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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

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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
explain the difference between accuracy and precision by describing a person weighing themselves on a scale
170 lb person ACCURATE but IMPRECISE scale = readings between 150-190 lbs INACCURATE but PRECISE scale = readings between 129-131 lbs
26
will an inaccurate or imprecise tool introduce bias or error? why?
bias is a SYSTEMATIC ERROR so only an INACCURATE tool will introduce bias, but an IMPRECISE tool will still introduce error
27
defn: random error
error introduced by random chance
28
how do we avoid random error?
usually overcome by a large sample size
29
defn: randomization
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
30
what will a proper randomization algorithm be equal to?
a coin toss or die roll
31
defn + func: blinded
the subjects and/or investigators do not have information about which group the subject is in to remove bias
32
defn: single-blind experiments
only the patient or the assessor is blinded
33
defn: assessor
the person who makes measurements on the patient or performs subjective evaluations
34
defn: double-blind experiments
the investigator, subject, and assessor all do not know the subject's group
35
how does the placebo effect differ between the control and treatment group WITHOUT blinding?
WITHOUT blinding, the placebo effect would be greatly reduced in the control group, but still be present in the treatment group
36
examples: binary vs. continuous vs. categorical variables
BINARY (yes vs no, better vs worse) CONTINUOUS (amount of weight lost, percent improvement in cardiac output) CATEGORICAL (state of residence, socioeconomic status)
37
what are the three types of observational studies?
1. cohort 2. cross-sectional 3. case-control
38
what do observational studies often look at?
the connections between exposures and outcomes
39
can observational studies demonstrate causality?
no, although the tendency toward causality can be demonstrated by Hill's criteria
40
defn: cohort studies
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
defn: cross-sectional studies
attempt to categorize patients into different groups at a single point in time
42
defn: case-control studies
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
defn: Hill's criteria
describe the components of an observed relationship that increase the likelihood of causality in the relationship
44
are all of the Hill's criteria necessary for a relationship to be causal?
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
why should relationships be described as correlations not causation for an observational study?
Hill's criteria do not provide any absolute guideline on whether a relationship is causal
46
what are the 9 Hill's criteria?
1. temporality 2. strength 3. dose-response relationship 4. consistency 5. plausibility 6. consideration of alternative explanations 7. experiment 8. specificty 9. coherence
47
defn: temporality (Hill's criteria)
the exposure (independent variable) MUST occur before the outcome (dependent variable)
48
defn: strength (Hill's criteria)
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
defn: dose-response relationship (Hill's criteria)
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
defn: consistency (Hill's criteria)
the relationship is found to be similar in multiple settings
51
defn: plausibility (Hill's criteria)
there is a reasonable mechanism for the independent variable to impact the dependent variable supported by existing literature
52
defn: consideration of alternative explanations (Hill's criteria)
if all other plausible explanations have been eliminated, the remaining explanation is more likely.
53
defn: experiment (Hill's criteria)
if an experiment can be performed, a causal relationship can be determined conclusively
54
defn: specificity (Hill's criteria)
the change in the outcome variable is only produced by an associated change in the independent variable
55
defn: coherence (Hill's criteria)
the new data and hypothesis are consistent with the current state of scientific knowledge
56
defn: bias vs. confounding
bias: a result of flaws in the data collection phase of an experimental or observational study confounding: an error during analysis
57
defn: selection bias
subjects used for the study are not representative of the target population
58
defn: detection bias + example
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
defn + aka: Hawthorne effect + why is this an example of bias?
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
defn: confounding
a data analysis error - the data may or may not be flawed, but an incorrect relationship is characterized
60
what is confounding inaccurately described as?
confounding bias or omitted variable bias
60
what are the four core ethical tenets of medicine?
1. beneficence 2. nonmaleficence 3. respect for patient autonomy 4. justice
60
defn + aka: confounding variables
aka: confounders defn: third-party variables that are the actual "cause" of a seemingly causal relationship between two variables
61
defn: beneficence
the obligation to act in the patient's best interest
62
defn: nonmaleficence
the obligation to avoid treatments or interventions in which the potential for harm outweighs the potential for benefit
63
defn: respect for patient autonomy
the responsibility to respect patients' decisions and choices about their own healthcare
64
defn: justice
the responsibility to treat similar patients with similar care and to distribute healthcare resources fairly
65
what are the three necessary pillars of research ethics and what document was this determined by?
1. respect for persons 2. justice 3. a slightly more inclusive version of beneficence the Belmont Report
66
defn: respect for persons
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
defn: informed consent
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
func: institutional review boards
put into place systematic protections against unethical studies
69
defn: vulnerable persons
children, pregnant individuals, and prisoners they require special protections above and beyond those taken with the general population
70
defn: justice in research
applies to both the SELECTION of a research topic and the EXECUTION of the research
71
defn: morally relevant differences + examples + non-examples
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
what is an example that may or may not be considered a morally relevant difference?
religion (to keep patient autonomy)
73
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?
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
in drug trials, can risk be put on a group that does not have the illness?
yes, as long as it has been address through informed consent and respect for persons has been maintained
75
defn: beneficence (research)
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
defn: equipoise
one cannot approach the research with the knowledge that one treatment is superior to the other
77
if it becomes evident that one treatment option is clearly superior before a study is scheduled to finish, what should happen?
the trial must be stopped because providing an inferior treatment is a net harm
78
defn: population
the complete group of every individual that satisfies the attributes of interest
79
defn: parameter
information that is calculated using every person in a population
80
defn: sample
any group taken from a population that does not include all individuals form the population ideally representative of a population
81
defn: statistic
information about a sample can be used to estimate population parameters (with large or repeated samples)
82
defn: internal validity vs. external validity
INTERNAL validity = support for causality EXTERNAL validity = generalizability
83
defn: high vs. low generalizability studies
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
what is an implication of the fact that we are interested in applying research to our patients?
we need to consider whether the data is sufficient for the recommendation or exclusion of any therapy or treatment plan
85
defn: statistically significant
not the result of random chance
86

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