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PFM > Week 5 ILAs > Flashcards

Week 5 ILAs Flashcards

1
Q

a type of descriptive study, detailed report on ONE patient, often used to describe unique cases or cases that show important variations of a disease

A

case report

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2
Q

a type of descriptive study, a series of group of cases reports on MULTIPLE patients who received a similar treatment, experienced a similar disease, or had a similar exposure; cannot show risk factor association with disease

A

case series

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3
Q

a type of descriptive study, frequency of disease and frequency of related factors are assessed in the present among INDIVIDUALS; measures disease prevalence; cannot show risk factor association DOES NOT ESTABLISH CAUSALITY

A

cross sectional

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4
Q

a type of descriptive study, compares frequency of disease and frequency of risk related factors across POPULATIONS

A

ecological

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5
Q

a type of analytical observational study, collecting data from filtered target audiences to understand issues particular to them

A

community surveys

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6
Q

a type of analytical observational study, compares a group of people with a disease to a group of people without a disease; attempts to identify risk factors and exposures that contribute to development of outcome of interest, measures are odds ratios

A

case-controls

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7
Q

a type of analytical observational study, compares a group with a given exposure or risk factor to a group without such risk factor/exposure; looks to see if risk factor is associated with later development of disease, can be retrospective or prospective, but risk factor MUST be present BEFORE disease development

A

cohort

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8
Q

a type of cohort, individuals are sampled and data collected about their past (useful to study rare diseases

A

retrospective

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9
Q

a type of cohort, individuals are followed over time and data is collected. No participants have disease at time of study onset (ex. Framingham Heart Study)

A

prospective

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10
Q

experimental studies involving humans, compares therapeutic benefits of >= 2 interventions, study quality improves when clinical trial is randomized, controlled, double blinded

A

clinical trials

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11
Q

a type of clinical trial, measures an intervention’s effect by randomly assigning individuals to an intervention group or control arm. considered “gold standard”

A

randomized controlled trial

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12
Q

a type of clinical trial, neither subject nor researcher knows whether the subject is in treatment or control group until clinical trial is over; makes results of study less likely to be biased

A

double blind

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13
Q

a type of clinical trial, trial of 2+ groups, one group gets active treatment, others get placebo, but everything else is same between groups, so that any difference in their outcome can be attributed to the active treatment

A

placebo-controlled trial

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14
Q

a type of clinical trial, test whether a new experimental treatment is not unacceptably less effective than an active control treatment already in use (no worse than standard treatment); underlying hypothesis is that the investigation treatment may not provide additional efficacy but may benefit patients or society regarding quality of life and/or cost

A

noninferiority trials

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15
Q

a type of clinical trial, similar to noninferiority, aims to show that a new treatment is no better and no worse than standard treatment

A

equivalence trials

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16
Q

a type of clinical trial, compares effect of series of 2 or more treatments on a subject, order of treatments is randomized, washout periods between treatments so subjects can act as own controls

A

crossover clinical trials

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17
Q

a type of clinical trial, all subjects analyzed according to original, randomly assigned treatment; no one excluded, tries to avoid various bias but may dilute true intervention effect in doing so

A

intention to treat analysis

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18
Q

phase of clinical trial, very small number of healthy volunteers or patients with disease of interest, open label, initial pharmacokinetic assessments via microdosing

A

phase 0

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19
Q

phase of clinical trial, small number of healthy volunteers or patients with disease of interest, open label, safety assessment via dose escalation to determine max tolerated dose

A

phase I

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20
Q

phase of clinical trial, moderate number of patients with disease of interest; randomized, controlled, anonymized, efficacy assessment and provides additional data on short term adverse side effects

A

phase II

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21
Q

phase of clinical trial, large number of patients with disease of interest

A

phase III

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22
Q

phase of clinical trial, postmarketing surveillance of patients after treatment is approved

A

phase IV

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23
Q

type of analytical interventional studies, evaluate the effects of interventions on health outcomes within a group that may be defined geographically or socially; can be randomized- groups, can be longitudinal cohort or cross sectional studies, if number of group is too small it can result in weak statistical power, ex) Kingston Newburgh Fluoride Trial

A

community interventions

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24
Q

considered highest quality evidence on research topic because their study design reduces bias and produces more reliable findings

A

systematic reviews and meta analyses

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25
Q

attempt to gather all research using defined methods to answer a specific question; entire process of selecting, evaluating, and synthesizing all available evidence

A

systematic reviews

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26
Q

method of statistical analysis that pools summary data (ex. means) from multiple studies to obtain a more precise estimate of the size of an effect; combining data from a systemic review

A

meta-analysis

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27
Q

when publication of a study results is based on direction, strength, or significance of the findings ex) positive findings more likely to be published, negative findings are not accepted

A

publication bias

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28
Q

helps determine if statistically significant results are meaningful; measures strength of relationship between 2 variables
= (mean of treatment group-mean of control group)/ standard deviation of control group
larger, the stronger the relationship between 2 variables

A

effect size

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29
Q

the extent of variability in study outcomes; estimated by meta analyses

A

heterogeneity

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30
Q

display of results from multiple studies on set of axes to check for heterogeneity

A

Forest plot

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31
Q

checks for existence of publication bias and heterogeneity

A

Funnel diagram

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32
Q

selection of a subset from a population to estimate characteristics of/represent the whole population

A

sampling

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33
Q

involves random selection, allowing strong statistical inferences about the entire population

A

probability sampling

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34
Q

involves non random selections based on convenience of other criteria, allowing easier collection of data

A

non-probability sampling

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35
Q

process by which participants in clinical trials are assigned by chance to separate groups that are given different treatments or other interventions

A

randomization

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36
Q

every member of a population has an equal chance of being selected (ex. using random number generator)

A

simple random sampling

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37
Q

population is divided into subgroups, then randomly or systemically sample individuals from each subgroup; can allow more precise conclusions by ensuring every subgroup properly represented

A

stratified random sampling

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38
Q

population is divided into subgroups (similar to overall population), then randomly select entire subgroup

A

cluster sampling

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39
Q

each member of a population is listed with a number; individuals are chosen at regular intervals

A

systematic

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40
Q

matched sampling pairs an individual in the group with an individual in the experimental group where the individuals share all characteristics EXCEPT THE ONE UNDER INVESTIGATION

A

matching

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41
Q

characteristics that prospective participants must have in order to be included in a study

A

inclusion criteria

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42
Q

factors that would disqualify a person from participating in a specific study

A

exclusion criteria

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43
Q

based on a single sequence of random assignments; more difficult to establish that the outcome was caused by treatment and not other variables; the researches ability to draw conclusions about study outcomes are greatly weakened due to threats to validity (ex. placebo effect)

A

simple randomization

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44
Q

blinds how trial participants are sorted into groups until moment of assignment; prevents selection bias affecting which patients are given treatment (which is what randomization is trying to avoid)

A

concealed allocation

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45
Q

the sum of all values divided by the total number of values, most affected by outliers (extreme values)
= sum of all values/ total number of values

A

mean

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46
Q

middle number in an ordered dataset

A

median

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47
Q

most frequent value; least affected by outliers

A

mode

48
Q

how much variability exists in a set of values, around the mean of these values

A

standard deviation

variance= (SD)^2
o=SD; n= sample size

49
Q

estimate of how much variability exists in a theoretical set of a sample means around the true population mean; decreases as a sample size increases

A

standard error

SE+ o/ sqrt(n)

50
Q

measure of dispersion of a sample (how closely the observations cluster around the mean); measure of the spread of a dataset

A

variability

51
Q

difference between the highest and lowest values

A

range

52
Q

range of the middle half of a distribution

A

interquartile range

53
Q

average distance from the mean

A

standard deviation

54
Q

average of squared distance from the mean

A

variance

55
Q

concept of how the data evens out, if a variable is extreme the first time you measure it, it will be closer to the average of the next time you measure it; describes how a random variable outside the norm eventually leads to return to the norm ex) winning streak
usually happens because of a sampling error

A

regression to the mean

56
Q

probability distribution that is symmetric about the mean, shows that data near the mean occur more frequently than data far from the mean, also called Gaussian distribution or bell shaped
for normal distribution, mean is the best measure of central tendency
for skewed data, median is better measure

A

normal distribution

57
Q

suggest 2 different populations; has 2 peaks or modes around which values tend to cluster within a single distribution

A

bimodal distribution

58
Q

mean > median > mode

A

positive skew

59
Q

mean < median < mode

A

negative skew

60
Q

conjecture based on knowledge obtained while formulating a question

A

hypothesis

61
Q

testing that the question or conjecture that the hypothesis is false, there is no statistically significant difference between the 2 groups
ex) there is no difference in students that have at least 6 hours of sleep the night prior to taking an exam vs students that study all/most of the night

A

null hypothesis

62
Q

that a drug or therapy performs better than chance
ex) students that have at least 6 hours of sleep prior to an exam will perform better on exams than students that study all night prior to exam

A

alternative hypothesis

63
Q

medical and biomedical research leads to discoveries and technologies of medicine that have direct application in clinical settings

A

parallelism between basic research and clinical practice

64
Q

formalizes the use of the scientific method in clinical decision making, use of the most current and best evidence from clinical trials to form diagnoses in individual patient cases; requires physicians to assess and understand what the best available evidence is, use his or her clinical judgment, and do so in the context of the patient’s values and preferences

A

evidence-based medicine

65
Q

to avoid personal biases within a RCT, the treating physician should not have any personal biases that one treatment is better than the other, there should be genuine uncertainty in the expert medical community whether a treatment will be beneficial
derives from assertion that no hypothesis can be rejected or accepted until an experiment is performed

A

equipoise in RCTs

66
Q

solves problems by forming possible explanations, or hypotheses, based on previous knowledge; search for order among facts by directing the process of fact selection and interpretation of observation
the more conclusive the evidence is the more probable the most reasonable hypothesis is

A

scientific method

67
Q

idiopathic

A
68
Q

Description: To examine whether a sedation strategy with dexmedetomidine can improve clinical outcomes in patients with sepsis undergoing ventilation. Patients received either sedation with dexmedetomidine (n = 100) or sedation without dexmedetomidine (control group; n = 101). This study represents an example of a:

A

randomized control trial

69
Q

Secondary HLH due to Streptococcus pneumoniae infection in a splenectomised patient for spherocytosis, a 37-year-old patient who was splenectomised in childhood for spherocytosis, without immuneprophylaxis induced by antipneumococcal vaccine. This study represents an example of a:

A

case study

70
Q

Sepsis has recently been defined as “life-threatening organ dysfunction caused by a dysregulated host response to infection”. A great amount of effort has been made to develop early treatments for sepsis through the Surviving Sepsis Campaign. Efforts have been made to define sepsis, septic shock and infection in the burn population but there is constant need for revisions. In this manuscript, we will discuss the differences in burn sepsis versus sepsis of the general population. This study represents an example of a:

A

systematic review

71
Q

We performed an observational study focusing on 129 very low birth weight infants. Thermal gradient alteration was defined as a difference of > 2°C maintained during 4 hours. We then determined its association with the late-onset sepsis variable through logistic regression. This study represents an example of a:

A

cohort study

72
Q

which study results would most likely lead to a large multicenter trial and may influence patient treatment?

A

randomized control trial

73
Q

induction of developmental defects in fetus by drugs or toxins, generally non inheritable type
determination: Tx pregnant female animals during early pregnancy
ex) thalidomide, alcohol, valproic acid

A

teratogenesis

74
Q

induction of genetic mutation in animals of any age leading to induction of inheritable abnormalities
determination: Ames test or “dominant lethal test”
ex) cancer chemotherapeutic agents

A

mutagenesis

75
Q

induction of malignant characteristics in cells
determination: Ames test exhibits moderate correlation with carcinogenicity in animal studies
ex) polycyclic aromatic hydrocarbons, coat tar, nitrosamines

A

carcinogenesis

76
Q

a detailed summary of results of all preclinical studies performed on a drug prepared by the developer, reviewed byFDA

A

investigational new drug application (IND)

77
Q

combined phases 1 and 2 of clinical trials

A

antineoplastic drugs

78
Q

financial and operational incentives for development of drugs to treat rare diseases

A

orphan disease

79
Q

most persuasive phases in clinical trials

A

phases 1-3

80
Q

least persuasive phase in clinical trials

A

phase 4- post marketing surveillance

81
Q

“generic” name of drug, only on per drug, US applied name committee

A

the non-proprietary name

82
Q

assigned by drug company, protected by law, paten lasts 20 years, “trade” name, registration lasts 50 years

A

the proprietary name

83
Q

requires written prescription, no refills without exam by MD, providers must keep in secured area

A

schedule II
prescription requirement for controlled substances

84
Q

prescription can be written or phoned by MD, DO, etc
prescription must be renewed every 6 months and can be refilled up to 6 times

A

schedules III and IV
prescription requirement for controlled substances

85
Q

prescription for many V’s (OTC), pt must be 18 years or older, and may need to sign pharmacist’s dispensing log
ex) cough syrup

A

schedule V
prescription requirement for controlled substances

86
Q

nonrandom sampling or treatment allocation of subjects such that the study population is not representative of the target population; most commonly a sampling bias
ex) the way a study ad is worded might discourage or encourage certain groups of people to participate

A

selection bias

87
Q

case and or controls selected from hospitals are less healthy and have different exposures

A

Berkson bias

88
Q

participants lost to follow up have different prognosis (or characteristics) than those who complete the study
ways to reduce: randomization, ensure choice of most appropriate comparison/reference group

A

attrition bias

89
Q

systematic error when participants do not remember previous events or experiences accurately and/or omit details ex) food journal
awareness of a disorder alters subjects’ recall, common in retrospective studies
ex) patients with a disease recall exposures after learning of similar cases

A

recall bias

90
Q

ways to reduce ___ bias- reduce time from exposure, use medical records to confirm self report, use other resources (diaries, calendars, texts, etc) to strengthen accuracy

A

recall bias

91
Q

information collected for use as a study variable is inaccurate, information gathered in systemically distorted manner
ex) using faulty sphygmomanometer
Hawthorne effect- participants change behaviors when they are aware they are being observed

ways to reduce:
use objective, standardized, previously tested methods of data collection, use placebo

A

measurement bias

92
Q

subjects in different groups are not treated the same; unfair amount of pressure applied to subjects, forcing them to complete responses quickly
ex) patients in treatment group spend more time in highly specialized hospital

A

procedure bias

93
Q

ways to reduce ___ bias: blinding and using a placebo reduce influence of participants and researches on procedures and interpretation of outcomes

A

procedure bias

94
Q

a factor related to both the exposure and the outcome distorts the effect on exposure on the outcome
ex) an uncontrolled study shows association btw drinking coffee and lung cancer. However, people who drink coffee may smoke more, which might explain this association

A

confounding bias

95
Q

ways to reduce ___ bias: multiple/repeated studies, crossover studies where subjects act as their own control, matching patients w/ similar characteristics in both treatment and control groups
effect modification: association shown differently in individual subgroups due to stratification by given factor even when there’s association btw exposure and outcome

A

confounding bias

96
Q

early detection interpreted as increased survival, but the disease course has not changed; early diagnosis of disease falsely makes it look like people are surviving longer
ex) breast cancer diagnosed early by mammography may seem to have exaggerated survival time because patients are known to have cancer for longer

A

lead time bias

97
Q

ways to reduce ____ bias: measure “back end” survival, adjust survival according to the severity of disease at the time of diagnosis

A

lead to time bias

98
Q

screening test detects diseases with long latency periods, while those with shorter latency periods become symptomatic earlier; overestimation of survival duration due to relative excess of cases detected that are slowly progressing
ex) slowly progressive cancer is more likely to detect by screening test than a rapidly progressive cancer

A

length time bias

99
Q

ways to reduce ___ bias: a randomized controlled trial assigning subjects to screening program or no screening

A

length time bias

100
Q

hypothesis of no difference or no relationship
ex) there is no association btw the disease and the risk factor in the population

A

null hypothesis (H0)

101
Q

hypothesis of some difference or relationship
ex) there is some association between the disease and the risk factor in the population

A

alternative hypothesis (H1)

102
Q

statistical tests performed to see if ____ hypothesis is true. If it is not, reject ____ and the ___ hypothesis is accepted and observed difference is statistically significant

A

null hypothesis (H0)
null hypothesis (H0)
alternative hypothesis (H1)

103
Q

probability of obtaining test reults at least as extreme as those observed during the test, assuming that H0 is correct
commonly accepted as 0.05
functions as evidence against H0
a small value (0.005) means there is a 5% chance the observed results happened merely by chance

A

P value

104
Q

Stating there is an effect or difference when one exists

A

H0 rejected in favor of H1/ Type I Error (a)

105
Q

stating there is no effect or difference when none exists

A

H0 not rejected/ Type II Error (b)

106
Q

also called false positive error, alpha is the probability of making a ___ error, increases significantly with multiple comparisons, if alpha increases= increase in statistical significance level

A

type I error (alpha)

107
Q

also called false negative error, Beta is the probability of making a ___ error.
when type __ error increases, type __ error decreases
Beta is the statistical power (1-B) which is the probability of rejecting H0 when it is false
increase sample size, increase power, decrease B

A

Type II error (beta)

108
Q

range of values likely to induce the true mean of population is expected to fall, with a specified probability

A

confidence interval

109
Q

comparison planned before data collection
based on prior knowledge, deductions, and theory

A

a priori analysis

110
Q

researchers choose additional comparisons to study after viewing the data
based on results of planned comparisons and viewing of the data
caveat: danger of fitting a theory around the data

A

post hoc analysis

111
Q

breaking down the sample into groups based on characteristics for comparison and to check consistency across population
can lead to spurious findings (false positives) and have too little power due to small sample sizes (false negatives)

A

subgroup analysis

112
Q

an investigator suspects that diphenhydramine use during the first trimester of pregnancy can cause neural tube defects. She estimates the risk of neural tube defect in the general population is 1:1000. What kind of study is this?

A

cohort study

113
Q

which parameter is most likely to be the least biased estimator of central tendency for this distribution of test scores?

A

mode

114
Q

500 women aged 40-54 are asked about meat consumption at routine check ups. 20% of the women are vegetarian. Over the next 5 years, 5 vegetarians and 43 non-vegetarians develop colorectal cancer. what kind of study is this ?

A

cohort study

115
Q

a group of patients with oropharyngeal cancer is matched to a group of patients without oropharyngeal cancer. their tobacco habits over the course of their lives are compared, and the researcher then compute the odds of tobacco use among the 2 groups. This is an example of

A

case control study

116
Q

a group of patients diagnosed with COVID 19 are contacted after diagnosis and at 6 and 12 months to identify prevalence of and risk factors for post acute sequelae of COVID 19. what kind of study is this

A

longitudinal study

117
Q

most useful technique in over-reporting from a placebo group

A

blinding

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