Couga Biostat Ethics

Front 1

Twin concordance study

Back 1

Compares the frequency with which both monozygotic twins or both dizygotic twins develop a disease. Measures heritability.

Front 2

Adoption study.

Back 2

Compares siblings raised by biologic vs adoptive parents. Measures heritability and influence of environmental factors.

Front 3

Define clinical trial.

Back 3

Experimental study involving humans. Compres therapeutic benefits of 2 or more treatments, or of treatment and placebo. Highest quality study when randomized controlled, and double blinded.

Front 4

Describe the study sample and purpose of each phase of clinical trials.

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(A) Phase I: Small number of patients, usually healthy; assess safety, toxicity, and pharmacokinetics.
(B) Phase II: Small number of patients with disease of interest; assesses treatment efficacy, optimal dosing, and adverse effects.
(C) Phase III: Large numbers of patients randomly assigned either to treatment under investigation or to the best available treatment (or placebo); compares the new treatment and the current standard of care. More convincing if double blinded.

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Meta analysis.

Back 5

Pools data from several studies to come to an overall conclusions. Achieves greater statistical power and integrates results of similar studies. Highest echelon of clinical evidence. May be limited by quality of individual studies or bias in study selection.

Front 6

Sensitivity

Back 6

Proportion of all people with disease who test positive. Value approaching 1 is desirable for ruling out disease and indicates low false negative rate. Used for screening diseases with low prevalence.
Sensitivity=TP/(TP+FN)

Front 7

Specificity

Back 7

Proportion of all people without disease who test negative.
Value approaching 1 is desirable for ruling IN disease and indicates a lot false positive rate.
Used as a confirmatory test after a positive screening test.
Specificity=TN/(TN+FP)

Front 8

Negative predictive value

Back 8

Proportion of negative test results that are true negative.
Probability that person actually is disease free given a negative test result.
NPV=TN/(FN+TN)

Front 9

Prevalence

Back 9

Point prevalence=(total cases in population in given time)/(total population at risk at a given time)
Prevalance is approximately incidence x disease duration.
Prevalence is>incidence for chronic diseases.
Prevalance=incidence or acute disease.

Front 10

Odds ratio for case control studies

Back 10

OR=(a/b)/(c/d)=ad/bc
Odds of having a disease in exposed group divided by odds of having disease in unexposed group. Approximates relative risk if prevalence of disease is not too high.

Front 11

Relative risk (RR) for cohort studies

Back 11

RR=[a/(a+b)]/[c/(c+d)]
Relative probability of getting a disease in the exposed group compared to the unexposed group.
Calculated as percent with disease in exposed group divided by percent with disease in unexposed group.

Front 12

Attributable risk

Back 12

AR=[a/(a+b)]-[c/(c+d)]
The difference in risk between exposed and unexposed groups, or the proportion of disease occurrences that are attributable to the exposure.

Front 13

Precision

Back 13

1. The consistency and reproducibility of a test (reliability)
2. The absence of random variation in the test.
Random error reduces precision in a test.

Front 14

Accuracy

Back 14

Accuracy is the trueness of test measurements (validity).
Systematic error reduces accuracy in test.

Front 15

Bias

Back 15

Occurs when 1 outcome is systematically favored over another. Systematic errors.

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Selection bias

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Nonrandom assignment to study group

Front 17

Recall bias

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Knowledge of presence of disorder alters recall by subjects

Front 18

Sampling bias

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Subjects are not representative relative to general population; therefore, results are not generalizable

Front 19

Late-look bias

Back 19

Information fathered at an inappropriate time

Front 20

Procedure bias

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Subjects in different gruops are not treated the same-e.g. more attention is paid to treatment group, stimulating greater complicance

Front 21

Confounding bias

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Occurs with 2 closely associated factors; the effect of 1 factor distorts or confuses the effect of the other

Front 22

Lead time bias

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Early detection confused with increased survival.

Front 23

Hawthorne effect

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Occurs when the group being studied changes its behavior to meet the expectations of the researcher.

Front 24

Ways to reduce bias:

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1. blind studies (double blind better)
2. placebo responses
3. crossover studies (each subject acts as own control)
4. randomization

Front 25

Describe positive skew statistical distribution

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Asymmetry with tail on right. Mean>median>mode

Front 26

Describe negative skew statistical distribution

Back 26

Asymmetry with tail on left.
Mean<median<mode

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Null hypothesis

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Hypothesis of no difference

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Alternative hypothesis

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Hypothesis that there is some difference

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Power

Back 29

(1-beta)
Probability of rejecting null hypothesis when it is in fact false, or the likelihood of finding a difference if one in fact exists. It depends on:
1. Total number of end points experienced by population.
2. Difference in compliance between treatment groups (differences in the mean values between groups).
3. size of expected effect.
If you increase the sample size you increase the power.

Front 30

Standard deviation vs standard error

Back 30

n=sample size
x=standard deviation
SEM=standard error of the mean.
SEM=x/square root of n
SEM<x, and SEM decreases as n increases.

Front 31

Confidence interval

Back 31

Range of values in which a specified probability of the means of repeated samples would be expected to fall.

Front 32

T test

Back 32

Checks difference b/w means of 2 groups

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ANOVA

Back 33

Checks difference between means of 3+ groups

Front 34

Chi squared

Back 34

Checks difference between 2 or more percentages or proportions of categorical outcomes (not mean values)

Front 35

Correlation coefficient

Back 35

R is always b/w -1 and 1. The closer the absolute value of r is to 1, the stronger the correlation b/w two variables.

Front 36

Primary, secondary, and tertiary prevention

Back 36

Primary-prevent disease occurrence (ex. Vaccination)
Secondary-early detection of disease (screening)
Tertiary-reduce disability from disease

Front 37

Reportable diseases

Back 37

Hep Hep Hep Hooray, the SSSMMART Chick is Gone!
HepA
HepB
HepC
HIV
Salmonella
Shigella
Syphilis
Measles
Mumps
AIDS
Rubella
Tuberculosis
Chickenpox
Gonorrhea

Front 38

Leading causes of death in US by age:
(1)Infants
(2) 1-14
(3) 15-24
(4) 25-64
(5) 65+

Back 38

(1)Infants: congenital anomalies, SGA/LBW, SIDS, maternal complications of pregnancy, RDS
(2) 1-14: Injuries, cancer, congenital anomalies, homicide, heart disease
(3) 15-24: Injuries, homicide, suicide, cancer, heart disease
(4) 25-64: Cancer, heart disease, injuries, suicide, stroke.
(5) 65+: heart disease, cancer, stroke, COPD, pneumonia, influenza

Front 39

Exceptions to informed consent

Back 39

-Patient lacks decision making capacity or is legally incompetent.
-Implied consent in an emergency.
-therapeutic privelage: withholding information when disclosure would severely harm the patient or undermine informed decision making capacity.
-waiver: patient waives right

Front 40

Two types of written advance directive:

Back 40

(1) living will-describes treatments the patient wishes to or not to receive if he/she becomes incapacitated.
(2) durable power of attorney-patient designates a surrogate to make medical decisions in the event that he/she loses decision making capacity.

Front 41

Exceptions to confidentiality:

Back 41

(1) Potential harm to others is serious.
(2) Liklihood of harm to self is great.
(3) no alternative means exist to warn or protect those at risk.
(3) Physicians can take steps to prevent harm:
Examples:
-Infectious disease
-Tarasoff decision: law requires physician to directly inform and protect potential victim from harm
-Child/elder abuse
-Impaired automobile drivers
-Suicidal/homicidal patients

Front 42

Requirements for civil suit under negligence (malpractice)

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1. physician had duty to patient (duty)
2. physician breached that duty (dereliction)
3. patient suffers harm (Damage)
3. breach of duty was what caused harm (Direct)

Front 43

Appropriate response:
Patient is noncompliant.

Back 43

Work to improve the physican-patient relationship.

Front 44

Appropriate response: Patient has difficulty taking medications.

Back 44

Provide written instructions; attempt to simplify the regimen.

Front 45

Appropriate response: family member asks for info about patients prognosis.

Back 45

Acoid discussing issues w/relatives without permission of the patient.

Front 46

Appropriate response: a 17 YO girl is pregnant and requests an abortion.

Back 46

Many states require parental notification or consent for minors wanting an abortion. Parental consent is not required for emergency situations, treatment of STD's medical care during pregnancy, and management of drug addiction.

Front 47

Appropriate response:
Terminally ill patient requests ending his life.

Back 47

In the overwhelming majority of states, refuse involvement in any form with physician assisted suicide. Physicans may, however, prescribe medically appropriate analgesics that coincidentally shorten the patients life.

Front 48

Appropriate response: Patient states that he finds you attractive.

Back 48

Ask direct, closed ended questions and use a chaperone if necessary. Romantic relationships with patients are never appropriate.

Front 49

Appropriate response: Patient refuses a necessary procedure or desires an uncessary one.

Back 49

Attempt to understand why the patient wants/does not want the procedure. Address the underlying concerns. Acoid performing uncessary procedures.

Front 50

Appropriate response: Patient is angry about the amnt of time he spent in the waiting room.

Back 50

Apologize to tha ptient for inconvenience. Stay away from exports to explain the delay.

Front 51

Appropriate response: Patient is upset with the way he was treated by another doctor.

Back 51

Suggest that the patient speak directly to that physician regarding his/her concerns. If the problem is with a member of his staff, tell the patient you will speak to that individual.

Front 52

Appropriate response: a child wishes to know more about his illness.

Back 52

Ask the parents have told the child about his illness. Parents of a child decide what info can be relayed about an illness.

Front 53

Appropriate response: Patients continue to smoke believing that cigarettes are good for them.

Back 53

Ask how the patients feel about his/her smoking. Offeradvice on cessation if the patient seems willing to make an effort to quit.

Front 54

Appropriate response: Minor requests condoms.

Back 54

Physicans can provide counsel and contracpetive to minors without parents' knowledge or consent.

Front 55

APGAR scale (description, components, and scoring)

Back 55

A 10 pt scale evaluated at 1 m and 5 m.
(1) Apperance (0=blue, 1=trunk pink, 2=all pink)
(2) Pulse (0=none, 2=<100/m, 3=>100/m)
(3) Grimace (0=none, 2=grimace, 3=grimace +cough)
(4) Activity (0=limp, 1=some, 2=active)
(5) Respiration (0=none, 1=irregular, 2=regular)

Front 56

low birth weight

Back 56

<25000g at birth. Associated with greater incidence of physical/emotional problems. Caused by prematurity or intrauterine growth retardation.

Front 57

Motor milestones for the following age groups:
(1) Birth-3m
(2) 3m
(3) 4-5m
(4) 7-9m
(5) 12-14m
(6) 15m
(7)18-24m
(8) 24-48m
(9) 24-36m
(10) 30-36m
(11) 3y
(12) 4y
(13) 6-11y

Back 57

(1) Birth-3m: Rooting reflex
(2) 3m: Holds head up, Moro reflex disappears
(3) 4-5m: Rolls front to back, sits when propped
(4) 7-9m: Sits alone, crawls
(5) 12-14m: Upgoing Babinski disappears
(6) 15m: walks
(7)12-24m: Climbs stairs, stacks 3 blocks
(8) 24-48m: "
(9) 24-36m"
(10) 30-36m: Stacks 9 blocks (number of blocks stacked=age in yrs x 3)
(11) 3y: rides tricycle, copies line or circle
(12) 4y: Simples drawings (stick figure), hopes on 1 foot, copies a cross
(13) 6-11y: Rides bicycle; copies a triangle (age 6)

Front 58

Cognitive/social milestones for the following age groups:
(1) Birth-3m
(2) 3m
(3) 4-5m
(4) 7-9m
(5) 12-14m
(6) 15m
(7)18-24m
(8) 24-48m
(9) 24-36m
(10) 30-36m
(11) 3y
(12) 4y
(13) 6-11y
(14) 11y (girls)/13y (boys)

Back 58

(1) Birth-3m: Orients to voice
(2) 3m: social smile
(3) 4-5m: recognizes people
(4) 7-9m: stranger anxiety
(5) 12-14m: n/a
(6) 15m: few words, separation anxiety
(7)12-24m: Object permanence; 200 words and 2 word sentences at 2
(8) 24-48m: parallel play
(9) 24-36m: core gender identity
(10) 30-36m: toilet training
(11) 3y: 900 words and complete sentences.
(12) 4y: cooperative play, imaginary friends, grooms self, brushes teeth, buttons and zips
(13) 6-11y: reads; understands death. Development of conscious (superego), same sex friends, identification w/same sex parent
(14) 11y (girls)/13y (boys): abstract reasoning (formal operations), formation of personality

Front 59

Tanner Stages of Development

Back 59

(1) Childhood
(2) Pubic hair begins to develop (adrenarche), increase size of testes, breast tissue elevation
(3) Increased pubic hair, darkens, becomes curly, increased penis size/length
(4) Increase penis width, darker scrotal skin, development of glans, raised areolae
(5) Adult; areolae no longer raised

Front 60

Changes in elderly
1-sexual
2-sleep
3-common medical conditions
4-psychiatric disorders
5-suicide rate
6-vision, hearing, immune response, bladder control
7-renal, pulmonary, GI fct
8-muscle mass, fat mass

Back 60

Changes in elderly
1-sexual:
Men=slower erection/ejac, longer refractory period
Women=vaginal shortening, thinning, and dryness
2-sleep: Decr REM, slow wave sleep. Incr latency, awakenings
3-common medical conditions: arthritis, HTN, HD, osteoperosis
4-psychiatric disorders: lower prevalence among healthy elderly than at other life stages (excluding comorbidities)
5-suicide rate (increased-males 65-74 have highest rates in US)
6-vision, hearing, immune response, bladder control (all decreased)
7-renal, pulmonary, GI (all decreased)
8-muscle mass (decr), fat mass (incr)

Front 61

Kubler Ross grief stages

Back 61

Denial, anger, bargaining, frieving (depression), acceptance
Do not have to occur in this order and greater than 1 can occur at once.

Front 62

Physiologic effects of stress

Back 62

-Induces production of FFA's
-Induced production of 17-OH (immunosuppression)
-Induces production of lipids, cholesterol, and catecholamines
-Affects water absorption
-Affects muscular tonicity
-Affects gastrocolic reflex
-Affects mucosal circulation

Front 63

Differential diagnosis for sexual dysfct

Back 63

Drug (antiHTN, neuroleptics, SSRI's, alcohol)
Diseases (depression, diabetes)
Psychological (performance anxiety)

Front 64

BMI (define and cutoffs)

Back 64

Measure of weight adjusted for height.
BMI=wt (kg)/ht(cm)2
<18.5 underwt
18.5-24.9 normal
25-29.9 overwt
>30 obese

Front 65

Describe the different stages of sleep (% of total sleep time, description, and EEG wave form); also include waveforms for being awake

Back 65

Awake eyes open (beta -highest frequency, lowest amplitude)
Awake eyes closed (alpha)
Stage1 (5%): Light sleep (theta)
Stage 2 (45%): deeper sleep; bruxism (Sleep spindles and K complexes)
Stage 3-4 (25%): Deepest, non REM sleep; sleepwalking, night terrors; bedwetting aka slow wave sleep (delta-lowest frequency, highest amplitude)
REM (25%): Dreams, loss of motor tone, possible memory processing fct, erections, increased brain oxygen use (beta)

Front 66

How are benzodiazepines useful for sleep aids?

Back 66

Shorten stage 4 sleep so are useful for night terrors and sleepwalking.

Front 67

How is imipramine used for sleep aid?

Back 67

Used to treat enuresis b/c it decreases stage 4 sleep.

Front 68

What neurotransmitter is necessary to initiate sleep?

Back 68

Serotonin predominance of raphe nucleus

Front 69

What neurotransmitter reduces REM sleep?

Back 69

NE

Front 70

What neurological structure is responsible for extraocular eye movements during REM?

Back 70

PPRF

Front 71

Principle neurotransmitter involved in REM sleep

Back 71

Ach

Front 72

Describe narcolepsy

Back 72

Disordered regulation of sleep-wake cycles. May include hypnagogic (before sleep) or hypnopompic (before awakening). Sleep episodes start with REM cycles. Cataplexy in some patients. Strong genetic component. Treat with stimulants (amphetamines, modafinil)

Front 73

Describe the neurologic control of circadian rhythm

Back 73

Driven by suprachiasmatic nucleus (SCN) of hypothalamus; controls ACTH, prolactin, melatonin, nocturnal NE release. SCN-->NE release-->pineal gland-->melatonin. SCN is regulated by environment (light).