Professional Documents
Culture Documents
It is a mathematical fact that fifty percent of all doctors graduate in the ` Epidemiology &
bottom half of their class. Biostatistics 246
Author Unknown
` Ethics 253
There are two kinds of statistics: the kind you look up and the kind you
make up. ` The Well Patient 258
Rex Stout
` Healthcare Delivery 259
On a long enough time line, the survival rate for everyone drops to zero.
Chuck Palahniuk ` Quality and Safety 261
There are three kinds of lies: lies, damned lies, and statistics.
Mark Twain
Medical ethics questions may seem less concrete than questions from
other disciplines. For example, if a patient does or says something,
what should you do or say in response? Many medical students do not
diligently study these topics because the material is felt to be easy or a
matter of common sense. In our opinion, this is a missed opportunity.
245
246 SEC TION II PUBLIC HEALTH SCIENCES `
PUBLIC HEALTH SCIENCESEPIDEMIOLOGY & BIOSTATISTICS
`
PUBLIC HEALTH SCIENCESEPIDEMIOLOGY & BIOSTATISTICS
Observational studies
STUDY TYPE DESIGN MEASURES/EXAMPLE
Cross-sectional study Frequency of disease and frequency of risk- Disease prevalence.
related factors are assessed in the present. Can show risk factor association with disease, but
Asks, What is happening? does not establish causality.
Case-control study Compares a group of people with disease to a Odds ratio (OR).
group without disease. Patients with COPD had higher odds of a
Looks to see if odds of prior exposure or risk history of smoking than those without COPD.
factor differs by disease state.
Asks, What happened?
Cohort study Compares a group with a given exposure or risk Relative risk (RR).
factor to a group without such exposure. Smokers had a higher risk of developing COPD
Looks to see if exposure or risk factor is than nonsmokers.
associated with later development of disease.
Can be prospective (asks, Who will
develop disease?) or retrospective (asks,
Who developed the disease [exposed vs
nonexposed]?).
Twin concordance Compares the frequency with which both Measures heritability and influence of
study monozygotic twins vs both dizygotic twins environmental factors (nature vs nurture).
develop the same disease.
Adoption study Compares siblings raised by biological vs Measures heritability and influence of
adoptive parents. environmental factors.
Clinical trial Experimental study involving humans. Compares therapeutic benefits of 2 or more treatments,
or of treatment and placebo. Study quality improves when study is randomized, controlled, and
double-blinded (ie, neither patient nor doctor knows whether the patient is in the treatment or
control group). Triple-blind refers to the additional blinding of the researchers analyzing the data.
Four phases (Does the drug SWIM?).
DRUG TRIALS TYPICAL STUDY SAMPLE PURPOSE
Phase I Small number of healthy volunteers. Is it Safe? Assesses safety, toxicity,
pharmacokinetics, and pharmacodynamics.
Phase II Small number of patients with disease of Does it Work? Assesses treatment efficacy,
interest. optimal dosing, and adverse effects.
Phase III Large number of patients randomly assigned Is it as good or better? Compares the new
either to the treatment under investigation or treatment to the current standard of care (any
to the best available treatment (or placebo). Improvement?).
Phase IV Postmarketing surveillance of patients after Can it stay? Detects rare or long-term
treatment is approved. adverse effects. Can result in treatment being
withdrawn from Market.
PUBLIC HEALTH SCIENCES `
PUBLIC HEALTH SCIENCESEPIDEMIOLOGY & BIOSTATISTICS SEC TION II 247
Test
false negative.
NPV
Sensitivity and specificity are fixed properties FN TN = TN/(TN + FN)
of a test. PPV and NPV vary depending on Sensitivity Specificity Prevalence
TP + FN
disease prevalence in population being tested. = TP/(TP + FN) = TN/(TN + FP) (TP + FN + FP + TN)
Sensitivity (true- Proportion of all people with disease who test = TP / (TP + FN)
positive rate) positive, or the probability that when the = 1 false-negative rate
disease is present, the test is positive. SN-N-OUT = highly SeNsitive test, when
Value approaching 100% is desirable for ruling Negative, rules OUT disease
out disease and indicates a low false-negative If sensitivity is 100%, then FN is zero. So, all
rate. High sensitivity test used for screening in negatives must be TNs.
diseases with low prevalence.
Specificity (true- Proportion of all people without disease who = TN / (TN + FP)
negative rate) test negative, or the probability that when the = 1 false-positive rate
disease is absent, the test is negative. SP-P-IN = highly SPecific test, when Positive,
Value approaching 100% is desirable for rules IN disease
ruling in disease and indicates a low false- If specificity is 100%, then FP is zero. So, all
positive rate. High specificity test used for positives must be TPs.
confirmation after a positive screening test.
Positive predictive Proportion of positive test results that are true PPV = TP / (TP + FP)
value positive. PPV varies directly with pretest probability
Probability that a person who has a positive test (baseline risk, such as prevalence of disease):
result actually has the disease. high pretest probability phigh PPV
Negative predictive Proportion of negative test results that are true NPV = TN / (TN + FN)
value negative. NPV varies inversely with prevalence or pretest
Probability that a person with a negative test probability: high pretest probability p low NPV
result actually does not have the disease.
FN FP
Raising the cutoff point: Specicity PPV
A B C B C ( FN FP)
Sensitivity NPV
Test results
For example, in diabetes screening, raising the blood glucose cutoff level at which a patient is diagnosed will sensitivity, specicity,
PPV, and NPV. The opposite changes occur with decreasing the blood glucose cutoff level.
Likelihood ratio LRs can be multiplied with pretest odds of sensitivity True positive rate
LR+ = =
disease to estimate posttest odds. LR+ >10 and/ 1 specificity False positive rate
or LR < 0.1 are easy-to-remember indicators of
a very useful diagnostic test. 1 sensitivity False negative rate
LR = =
specificity True negative rate
248 SEC TION II PUBLIC HEALTH SCIENCES `
PUBLIC HEALTH SCIENCESEPIDEMIOLOGY & BIOSTATISTICS
Quantifying risk Definitions and formulas are based on the classic Disease
2 2 or contingency table.
or intervention
Risk factor
a b
c d
Incidence vs Incidence = # of new cases (during a specified Incidence looks at new cases (incidents).
prevalence rate # of people at risk time period)
# of existing cases (at a point in Prevalence looks at all current cases.
Recurrence Prevalence =
Total # of people time)
Incidence
in a population
Prevalence Prevalence = Incidence rate average duration
1 prevalence of disease
Mortality Cure
Prevalence incidence for short duration disease Prevalence pretest probability.
(eg, common cold). qprevalence pqPPV and rNPV.
Prevalence > incidence for chronic diseases, due to
large # of existing cases (eg, diabetes).
Precision vs accuracy
Precision (reliability) The consistency and reproducibility of a test. Random error r precision in a test.
The absence of random variation in a test. qprecision p r standard deviation.
q precision p q statistical power (1 ).
Accuracy (validity) The trueness of test measurements. Systematic error r accuracy in a test.
The absence of systematic error or bias in a test.
Accuracy Accuracy
High Low High Low
Statistical distribution
Measures of central Mean = (sum of values)/(total number of values). Most affected by outliers (extreme values).
tendency Median = middle value of a list of data sorted If there is an even number of values, the median
from least to greatest. will be the average of the middle two values.
Mode = most common value. Least affected by outliers.
Measures of Standard deviation = how much variability = SD; n = sample size.
dispersion exists in a set of values, around the mean of Variance = (SD)2.
these values. SE = /n.
Standard error = an estimate of how much SE r as n q.
variability exists in a (theoretical) set of sample
means around the true population mean.
Normal distribution Gaussian, also called bell-shaped.
1 +1
Mean = median = mode.
2 +2
3 +3
68%
95%
99.7%
Nonnormal distributions
Bimodal Suggests two different populations (eg,
metabolic polymorphism such as fast vs
slow acetylators; age at onset of Hodgkin
lymphoma; suicide rate by age).
Positive skew Typically, mean > median > mode. Mode
Median
Asymmetry with longer tail on right. Mean
Statistical hypotheses
Null (H0) Hypothesis of no difference or relationship (eg, Reality
there is no association between the disease and H1 H0
the risk factor in the population).
Alternative (H1) Hypothesis of some difference or relationship Power
Study rejects H0
(eg, there is some association between the ( 1 ) Type I error
disease and the risk factor in the population).
Confidence interval Range of values within which the true mean If the 95% CI for a mean difference between 2
of the population is expected to fall, with a variables includes 0, then there is no significant
specified probability. difference and H0 is not rejected.
CI for population mean = x Z(SE) If the 95% CI for odds ratio or relative risk
The 95% CI (corresponding to = .05) is often includes 1, H0 is not rejected.
used. If the CIs between 2 groups do not overlap
For the 95% CI, Z = 1.96. pstatistically significant difference exists.
For the 99% CI, Z = 2.58. If the CIs between 2 groups overlap p usually
no significant difference exists.
PUBLIC HEALTH SCIENCES `
BEHAVIORAL SCIENCEETHICS SEC TION II 253
Pearson correlation r is always between 1 and +1. The closer the absolute value of r is to 1, the stronger the linear
coefficient correlation between the 2 variables.
Positive r value p positive correlation (as one variable q, the other variable q).
Negative r value p negative correlation (as one variable q, the other variable r).
Coefficient of determination = r 2 (amount of variance in one variable that can be explained by
variance in another variable).
r = 0.8 r = 0.4 r=0 r = +0.4 r = +0.8
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BEHAVIORAL SCIENCEETHICS
Informed consent A process (not just a document/signature) that Exceptions to informed consent:
requires: Patient lacks decision-making capacity or is
Disclosure: discussion of pertinent legally incompetent
information Implied consent in an emergency
Understanding: ability to comprehend Therapeutic privilegewithholding
Capacity: ability to reason and make ones information when disclosure would severely
own decisions (distinct from competence, a harm the patient or undermine informed
legal determination) decision-making capacity
Voluntariness: freedom from coercion and Waiverpatient explicitly waives the right of
manipulation informed consent
Patients must have an intelligent understanding
of their diagnosis and the risks/benefits of
proposed treatment and alternative options,
including no treatment.
Patient must be informed that he or she can
revoke written consent at any time, even orally.
Consent for minors A minor is generally any person < 18 years old. Situations in which parental consent is usually
Parental consent laws in relation to healthcare not required:
vary by state. In general, parental consent Sex (contraception, STIs, pregnancy)
should be obtained, but exceptions exist for Drugs (substance abuse)
emergency treatment (eg, blood transfusions) Rock and roll (emergency/trauma)
or if minor is legally emancipated (eg, married, Physicians should always encourage healthy
self supporting, or in the military). minor-guardian communication.
Physician should seek a minors assent even if
their consent is not required.
Decision-making Physician must determine whether the patient is psychologically and legally capable of making a
capacity particular healthcare decision. Note that decisions made with capacity cannot be revoked simply
if the patient later loses capacity.
Capacity is determined by a physician for a specific healthcare-related decision (eg, to refuse
medical care). Competency is determined by a judge and usually refers to more global categories
of decision making (eg, legally unable to make any healthcare-related decision).
Components:
Patient is 18 years old or otherwise legally emancipated
Patient makes and communicates a choice
Patient is informed (knows and understands)
Decision remains stable over time
Decision is consistent with patients values and goals, not clouded by a mood disorder
Decision is not a result of altered mental status (eg, delirium, psychosis, intoxication)
PUBLIC HEALTH SCIENCES `
BEHAVIORAL SCIENCEETHICS SEC TION II 255
Advance directives Instructions given by a patient in anticipation of the need for a medical decision. Details vary per
state law.
Oral advance directive Incapacitated patients prior oral statements commonly used as guide. Problems arise from variance
in interpretation. If patient was informed, directive was specific, patient made a choice, and
decision was repeated over time to multiple people, then the oral directive is more valid.
Written advance Specifies specific healthcare interventions that a patient anticipates he or she would accept or reject
directive during treatment for a critical or life-threatening illness. A living will is an example.
Medical power of Patient designates an agent to make medical decisions in the event that he/she loses decision-
attorney making capacity. Patient may also specify decisions in clinical situations. Can be revoked by
patient if decision-making capacity is intact. More flexible than a living will.
Do not resuscitate DNR order applies to cardiopulmonary resuscitation (CPR). Other resuscitative measures that follow
order (cardioversion, intubation) are also typically avoided.
Surrogate decision- If a patient loses decision-making capacity and has not prepared an advance directive, individuals
maker (surrogates) who know the patient must determine what the patient would have done. Priority of
surrogates: spouse padult Children pParents pSiblings pother relatives (the spouse ChiPS
in).
Confidentiality Confidentiality respects patient privacy and autonomy. If patient is not present or is incapacitated,
disclosing information to family and friends should be guided by professional judgment of
patients best interest. The patient may voluntarily waive the right to confidentiality (eg, insurance
company request).
General principles for exceptions to confidentiality:
Potential physical harm to others is serious and imminent
Likelihood of harm to self is great
No alternative means exist to warn or to protect those at risk
Physicians can take steps to prevent harm
Examples of exceptions to patient confidentiality (many are state-specific) include the following
(The physicians good judgment SAVED the day):
Suicidal/homicidal patients
Abuse (children, elderly, and/or prisoners)
Duty to protectState-specific laws that sometimes allow physician to inform or somehow
protect potential Victim from harm.
Epileptic patients and other impaired automobile drivers.
Reportable Diseases (eg, STIs, hepatitis, food poisoning); physicians may have a duty to warn
public officials, who will then notify people at risk. Dangerous communicable diseases, such as
TB or Ebola, may require involuntary treatment.
256 SEC TION II PUBLIC HEALTH SCIENCES `
BEHAVIORAL SCIENCEETHICS
Ethical situations
SITUATION APPROPRIATE RESPONSE
Patient is not adherent. Attempt to identify the reason for nonadherence and determine his/her willingness to
change; do not coerce the patient into adhering and do not refer him/her to another
physician.
Patient desires an unnecessary Attempt to understand why the patient wants the procedure and address underlying
procedure. concerns. Do not refuse to see the patient and do not refer him/her to another
physician. Avoid performing unnecessary procedures.
Patient has difficulty taking Provide written instructions; attempt to simplify treatment regimens; use teach-back
medications. method (ask patient to repeat regimen back to physician) to ensure comprehension.
Family members ask for information Avoid discussing issues with relatives without the patients permission.
about patients prognosis.
A patients family member asks you Attempt to identify why the family member believes such information would be
not to disclose the results of a test detrimental to the patients condition. Explain that as long as the patient has decision-
if the prognosis is poor because making capacity and does not indicate otherwise, communication of information
the patient will be unable to concerning his/her care will not be withheld. However, if you believe the patient
handle it. might seriously harm himself or others if informed, then you may invoke therapeutic
privilege and withhold the information.
A 17-year-old girl is pregnant and Many states require parental notification or consent for minors for an abortion. Unless
requests an abortion. there are specific medical risks associated with pregnancy, a physician should not
sway the patients decision for an elective abortion (regardless of maternal age or fetal
condition).
A 15-year-old girl is pregnant and The patient retains the right to make decisions regarding her child, even if her parents
wants to keep the child. Her disagree. Provide information to the teenager about the practical issues of caring for
parents want you to tell her to give a baby. Discuss the options, if requested. Encourage discussion between the teenager
the child up for adoption. and her parents to reach the best decision.
A terminally ill patient requests In the overwhelming majority of states, refuse involvement in any form of physician-
physician assistance in ending assisted suicide. Physicians may, however, prescribe medically appropriate analgesics
his/her own life. that coincidentally shorten the patients life.
Patient is suicidal. Assess the seriousness of the threat. If it is serious, suggest that the patient remain in the
hospital voluntarily; patient can be hospitalized involuntarily if he/she refuses.
Patient states that he/she finds you Ask direct, closed-ended questions and use a chaperone if necessary. Romantic
attractive. relationships with patients are never appropriate.
A woman who had a mastectomy Find out why the patient feels this way. Do not offer falsely reassuring statements (eg,
says she now feels ugly. You still look good).
Patient is angry about the long time Acknowledge the patients anger, but do not take a patients anger personally. Apologize
he/she spent in the waiting room. for any inconvenience. Stay away from efforts to explain the delay.
Patient is upset with the way he/she Suggest that the patient speak directly to that physician regarding his/her concerns. If the
was treated by another doctor. problem is with a member of the office staff, tell the patient you will speak to that person.
An invasive test is performed on the Regardless of the outcome, a physician is ethically obligated to inform a patient that a
wrong patient. mistake has been made.
PUBLIC HEALTH SCIENCES `
BEHAVIORAL SCIENCEETHICS SEC TION II 257
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PUBLIC HEALTH SCIENCESTHE WELL PATIENT
Early developmental Milestone dates are ranges that have been approximated and vary by source. Children not meeting
milestones milestones may need assessment for potential developmental delay.
AGE MOTOR SOCIAL VERBAL/COGNITIVE
Infant Parents Start Observing,
012 mo Primitive reflexes disappear Social smile (by 2 mo) Orientsfirst to voice (by
Moro (by 3mo), rooting (by Stranger anxiety (by 6 mo) 4mo), then to name and
4mo), palmar (by 6 mo), Separation anxiety (by 9 mo) gestures (by 9mo)
Babinski (by 12mo) Object permanence (by 9 mo)
Posturelifts head up prone (by Oratorysays mama and
1mo), rolls and sits (by 6mo), dada (by 10 mo)
crawls (by 8 mo), stands (by
10mo), walks (by 1218 mo)
Pickspasses toys hand to
hand (by 6 mo), Pincer grasp
(by 10mo)
Points to objects (by 12 mo)
Toddler Child Rearing Working,
1236 mo Cruises, takes first steps (by Recreationparallel play (by Words200 words by age 2
12mo) 2436mo) (2zeros), 2-word sentences
Climbs stairs (by 18 mo) Rapprochementmoves away
Cubes stackednumber from and returns to mother
= age (yr) 3 (by 24 mo)
Cutleryfeeds self with fork Realizationcore gender
and spoon (by 20 mo) identity formed (by 36 mo)
Kicks ball (by 24 mo)
Preschool Dont Forget, theyre still Learning!
35 yr Drivetricycle (3 wheels at Freedomcomfortably spends Language1000 words by age
3yr) part of day away from mother 3 (3 zeros), uses complete
Drawingscopies line or (by 3 yr) sentences and prepositions
circle, stick figure (by 4 yr) Friendscooperative play, has (by 4 yr)
Dexterityhops on one foot imaginary friends (by 4 yr) Legendscan tell detailed
(by 4yr), uses buttons or stories (by 4 yr)
zippers, grooms self (by 5 yr)
Car seats for children Children should ride in rear-facing car seats until they are 2 years old and in car seats with a
harness until they are 4 years. Older children should use a booster seat until they are 8 years old
or until the seat belt fits properly. Children < 12 years old should not ride in a seat with a front-
facing airbag.
PUBLIC HEALTH SCIENCES `
PUBLIC HEALTH SCIENCESHEALTHCARE DELIVERY SEC TION II 259
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PUBLIC HEALTH SCIENCESHEALTHCARE DELIVERY
Disease prevention
Primary Prevent disease before it occurs (eg, HPV
vaccination)
Secondary Screen early for and manage existing but
asymptomatic disease (eg, Pap smear for
cervical cancer)
Tertiary Treatment to reduce complications from Quaternaryidentifying patients at risk of
disease that is ongoing or has long-term effects unnecessary treatment, protecting from the
(eg,chemotherapy) harm of new interventions (eg, electronic
sharing of patient records to avoid duplicating
recent laboratory and imaging studies)
Hospice care Medical care focused on providing comfort and palliation instead of definitive cure. Available to
patients on Medicare or Medicaid and in most private insurance plans whose life expectancy is
<6 months.
During end-of-life care, priority is given to improving the patients comfort and relieving pain, and
care often includes opioid medications. Facilitating comfort is prioritized over potential side
effects (eg, respiratory depression). This prioritization of positive effects over negative effects is
known as the principle of double effect.
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PUBLIC HEALTH SCIENCESQUALITY AND SAFET Y
Safety culture Organizational environment in which everyone Event reporting systems collect data on errors for
can freely bring up safety concerns without internal and external monitoring.
fear of censure. Facilitates error identification.
Human factors design Forcing functions (those that prevent Deficient designs hinder workflow and lead to
undesirable actions [eg, connecting feeding staff workarounds that bypass safety features
syringe to IV tubing]) are the most effective. (eg, patient ID barcodes affixed to computers
Standardization improves process reliability (eg, due to unreadable wristbands).
clinical pathways, guidelines, checklists).
Simplification reduces wasteful activities (eg,
consolidating electronic medical records
[EMRs]).
Harm
Defense
strategies
Types of medical May involve patient identification, diagnosis, monitoring, nosocomial infection, medications,
errors procedures, devices, documentation, handoffs. Errors causing harmful outcomes must be disclosed
to patients.
Active error Occurs at level of frontline operator (eg, wrong Immediate impact.
IV pump dose programmed).
Latent error Occurs in processes indirect from operator but Accident waiting to happen.
impacts patient care (eg, different types of IV
pumps used within same hospital).