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Statistical Signifcance

Basic terms:
n = sample size
N = population size
= standard deviation (the square root of the variance)
Rememer the percentage of samples that fall !ithin "# $# and %
standard deviations () of the mean:
&ercent of samples !ithin : '()
&ercent of samples !ithin $: *+)
&ercent of samples !ithin %: **,-)
Standard error of the mean (S./) = 01n
2he mean is calculated from a sample and changes from sample to
sample 3 the S./descries ho! much the mean can var4 from sample to
5orrelation coe6cient: calculates ho! closel4 related t!o measures
are7 values closer to " are more strongl4 correlated !hile values closer to
8" have strong negative correlation
5onfdence 9nterval (59): measures how reliable an estimate is
But rememer that for a *+) 59# +) of the time the outcome !ill
fall outside of the *+) range, :or a (;) 59# $;) of the time the outcome
!ill fall outside of the 59 range
9f the 59 range includes ;# the null h4pothesis is not re<ected 3 no
statisticall4 signifcant di=erence !as found
5alculates the proailit4 that the di=erent means et!een 2
groups is real
Requires normall4 distriuted# continuous measures
>N?@> (>nal4sis of @ariance)
Similar to the t8test# eAcept for 3 or more groups
Similar to t8test# eAcept it is used for categorical measures 3
calculates !hether or not a di=erence et!een t!o
percentages0proportions (not means) is real
Statistical Cistriutions

Statistical Distribution is a continuous proailit4 distriution# !hich is
a function that predicts the proailit4 that an oservation !ill fall
et!een t!o real numers, 2here are three main t4pes of
distriutions7 Normal Distribution, Bimodal Distribution, and
Skewed Distribution.

Statistical Characteristics: 2hese three statistical distriutions all share
the same underl4ing statistical traits,
Mean 8 >lso Dno!n as the average of oserved values,
.Aample: Set = ("# %# (# ";# ";# ";# "E# "(# "(# $$# $'# $-# %$)

" F % F ( F "; F "; F "; F "E F "( F "( F $$ F $' F $- F %$
= "**0"% = "-,%;( = !
Mean is appro"imatel# !
Mode 8 2he most frequentl4 occurring oservation in a set of data,
.Aample: Set = G"# %# (# ";# ";# ";# "E# "(# "(# $$# $'# $-# %$H
Mode is $# since "; is the most frequentl4 occurring oservation
!ithin this data set,
Median 8 2he middle value separating the lo!er half of a distriution from
the upper half of a distriution,
.Aample: Set = G"# %# (# ";# ";# ";# "E# "(# "(# $$# $'# $-# %$H
Median is %, or the !th &alue in the list since it is the eAact
middle value separating the upper half of the distriution from the lo!er

Normal Distribution:
>lso Dno!n as the 'aussian distribution
5an e defned 4 mean()* and standard de&iation(*.
9t is a s#mmetric distriution,
>t the highest point on the ell curve the mean + mode + median.
>ll oservations !ill fall !ithin a certain standard deviation
F08 " S2C = ,-.
F08 $ S2C = /0.
F08 % S2C = //.!.
Skewed Distribution:
Skewness is the measure of as4mmetr4 !ithin a proailit4
distriution, > sDe!ed distriution often indicates the presence of an
outlier !ithin the results
1ositi&e skew has the tail trailing o= to the right, /ode I /edian
I /ean
Negati&e skew has the tail trailing o= to the left, /ode J /edian
J /ean
K4potheses and .rror 24pes

Null K4pothesis (K;): no di=erence et!een $ groups, .Aamples:
Leeping lood sugars I "(; in criticall4 ill patients doesnMt decrease
>lternative K4pothesis (K"): there is a di=erence et!een $ groups
.Aample: treating septic patients !ith antiiotics lo!ers their
mortalit4 rate
24pe " .rror (N): incorrectl4 accept K" as true
2he p &alue measures the proailit4 of committing 24pe " errors
24pe $ .rror (O): failing to re<ect K; !hen the null h4pothesis is false
.Aample: declaring a guilt4 man innocent
O is the proailit4 of maDing this error
&o!er= "8O
&roailit4 of fnding a Ptrue e=ectP, 9ncludes oth re<ecting K; !hen
K; is false and accepting K" !hen K" is true
Cependent on sample size: the larger the sample# the more liDel4
the results reQect the events in the population
R sample size R the stud4Ms po!er
9ncidence S &revalence

1re&alence: proportion of population !0 a disease at a particular point in
time (i,e,# point prevalence) or during a particular period of time (i,e,#
period prevalence)
1oint pre&alence:
2otal T of cases of a disease at a given point in time 0 2otal population at
risD at that time
1eriod pre&alence:
2otal T of cases of a disease during a given period of time 0 2otal
population at risD during that time period
2ncidence: rate at !hich ne! cases occur in a population
9ncidence is the numer of ne! cases in a time period divided 4
the numer of people at risD for ecoming a ne! case,
T ne! cases
UT at risD for ecoming a ne! case
1re&alence + 2ncidence " Duration
8 5hronic diseases: prevalence J incidence
8 >cute (short8lived) diseases: prevalence V incidence
.Aample of a chronic disease in !hich prevalence J incidence:
8 prevalence of 9BC (inQammator4 o!el disease) is W%;; cases per
";;#;;; persons
8 annual incidence of 9BC is W"( ne! cases per 4ear per ";;#;;; persons
Specifcit4# Sensitivit4# &&@ S N&@

$X$ tales are often constructed !0 t!o8letter areviations:
Y 2&=true positive
8 :&=false positive
8 :N=false negative
8 2N=true negative
!0 single8letter variales:
8 a=2&
8 =:&
8 c=:N
8 d=2N
Zse !hichever convention !orDs est for 4ou,



&ositive 2est Result
(or RisD :actor
2& :& 2&F:&
Negative 2est Result
(or RisD :actor
2N :NF2N



&ositive 2est Result
(or RisD :actor
a aF
Negative 2est Result
(or RisD :actor
d cFd
Sensiti&it# + 31 rate + 4 5N rate + 316(3175N* + a6(a7c*
P9f 4ou have a disease# !hat ) of the time !ill 4our test e

", of true positive results 0 total T of positive persons

Zse high8sensitivit4 tests to rule out disease: 2ests !ith sensitivit4
close to " have a lo! false8negative rate
Speci8cit# + 3N rate + 4 51 rate + 3N6(3N751* + d6(b7d*
P9f 4ou donMt have a disease# !hat percent of the time !ill 4our test
e negative[P

", of true negative results 0 total T of negative persons

9ule in: 2ests !ith specifcit4 close to " have a lo! false8positive
9deal tests have oth high sensitivit4 and high specifcit4
/an4 tests are onl4 sensitive or onl4 specifc 3 use a sensitive test
to screen and a specifc test to confrm diagnosis
11: (positi&e predicti&e &alue* + 316(31751* + a6(a7b*
P9f 4ou get a positive test result# !hat ) of the time do
4ou K>@. the disease[P
N1: (negati&e predicti&e &alue* + 3N6(5N73N* + d6(c7d*
P9f 4ou get a negative test result# !hat ) of the time do
4ou N?2 have the disease[P
KereMs an eAample: \iven a test that checDs for the presence of P]P:
Sensitivit4 = a 0 (aFc) = -%"0(;* = *;)
Specifcit4 = d 0 (Fd) = "+;;0"--; = (+)
&&@ = a 0 (aF) = -%"0";;" = -%)
N&@ = d 0 (cFd) = "+;;0"+-( = *+)
&revalence = (aFc) 0 (aFFcFd) = (;*0$+-* = %$)
&redictive values are dependent on disease pre&alence, 9f
prevalence fell to %,$) (population sta4s the same):
a=-% 3 =%("
c=( 3 d=$""-
&&@ = a 0 (aF) = -%0E+E = "')
N&@ = d 0 (cFd) = $""-0$"$+ = **,')
:or eAample# compare the &&@ of a test result for chlam4dia in $
8 > convent
8 > homeless shelter
Because the pre&alence is liDel4 to e lo!er in the population from the
convent# the &&@of a positive result is also lo! in this population,
>solute RisD Reduction
;bsolute risk reduction: 2he di=erence in asolute risDs et!een $
groups given an intervention, Note that an intervention can decrease the
risD of a bad outcome or canincrease the chances of good outcome,
>RR = >R" Y >R$
.Aample ": >n eAperimental drug is designed to decrease
perioperative mortalit4 in patients !ith heart disease, 2he control group
receives eta locDers and eAperiences a "+) complication rate, 2he
eAperimental group receives the ne! drug and eAperiences a ";)
complication rate,
2he asolute risD reduction is "+8"; = +),
.Aample $: >n eAperimental drug is designed to reduce the risD of
ischemic stroDes follo!ing suarachnoid hemorrhage (S>K), 2he control
group receives a placeo and %+) of patients su=er an ischemic stroDe,
$;) of the patients in the treatment group su=er an ischemic stroDe,
2he asolute risD reduction is %+8$; = "+),
Numer Needed to 2reat or Karm

Numer needed to treat: 2he numer of su<ects needed for therapeutic
eneft to e oserved in one memer of the stud4 population,
>llo!s comparison of e6cac4 et!een di=erent treatments,
?ften compared to placeo or no treatment groups,
NN2 = "0(asolute risD reduction)
.Aample ": 9f the risD of developing lung cancer in 5incinatti is ",+)
and the risD in St, ^ouis is ;,+)# the numer of people !ho !ould have to
move from 5inncinatti to St, ^ouis for one person to avoid contracting lung
cancer due to the move !ould e ";; (NN2 = "0>RR = "0(;,;"+8;,;;+)),
.Aample $: > ne! drug is developed to decrease post8operative
leeding in anti8coagulated patients after orthopedic surger4, 2he control
group receives .noAaparin and has a +) complication (leeding) rate, 2he
treatment group receives Crug _ and has a $,+) complication (leeding)
2he >RR = +8$,+ = $,+)
2he NN2 = "0(;,;$+) = E;, 2hus E; people must e treated !ith Crug _ in
order to prevent one person from having a post8operative leed follo!ing
orthopedic surger4,
.Aample %: >spirin treatment in patients !ith acute m4ocardial
infarction decreases the %; da4 mortalit4 from "+) to +),
>RR = "+8+ = ";)
NN2 = "0(;,") = ";, 2hus "; people must e treated to prevent one
person from d4ing !ithin %; da4s of an acute /9,
Numer needed to harm: 2he numer of su<ects !ho must e eAposed to
a given risD factor for one person to e harmed,
NNK = "0(attriutale risD)
.Aample ": Sa4 that eAposure to a certain level of enzene is sho!n
to increase the risD of leuDemia 4 ;,+), 2he numer of people !ho !ould
have to e eAposed to enzene for one additional case of leuDemia to e
demonstrated relative to controls !ould e $;; (NNK = "0(attriutale
risD) = "0(;,;;+)),
.Aample: > ne! drug is developed to attempt to decrease the risD
of post8operative leeding in anti8coagulated patients after orthopedic
surger4, 2he control group receives .noAaparin and has a +) complication
rate, 2he treatment group receives Crug ] and has a ";) complication
2he absolute risk increase is ";8+ = +)
2he NNK = "0(;,;+) = $;, 2hus# $; people must e treated !ith Crug ] to
cause one patient to have post8operative leeding,
&recision and >ccurac4

1recision and accurac# are used to descrie the mean of a data set,
&recision: Reliailit4 of an estimate of the mean,
> more precise estimate is one in !hich data sets across multiple
tests agree !ith one another 3 narro!er confdence interval,
>ccurac4: Ko! close the estimate is to the true mean,
> more accurate estimate is one that lies closer to the true mean 3
!ider confdence intervals,

:alidit# is a term to used to descrie the qualit4 of a stud4 3 the
trust!orthiness of the results,
@alidit4 directl4 correlates !ith the accurac4 of the reported results,
2nternal :alidit# is an assessment of a stud4Ms design and eAecution and
evaluates !hether the stud4 adequatel4 and e=ectivel4 investigates the
h4potheses# such that the conclusions dra!n from the results are correct,
9nternal validit4 3 results are accurate,
9nternal validit4 is required if a stud4Ms fndings are to e
incorporated into clinical practice,
@ariales that a=ect internal validit4:
;BCD<5 1ower=
<"ternal &alidit# is a term used to descrie
the applicabilit# or >generali?ablilit#> of a stud4Ms fndings to
populations e4ond those that have een studied,
.Aternal validit4 3 the results of the stud4 are true outside of the
stud4 population,
@ariales that a=ect eAternal validit4 are demographic features that
di=er et!een stud4 populations and patient populations# such as age#
gender# past medical histor4# or location, 9f patients of certain
demographics !ere not included in a stud4# the fndings of that stud4 ma4
not e applicale to them,
9nternal @alidit4
9nternal validit4 can e evaluated using: ;BCD<5 1ower=,
;rms: Stud4 arms should e equivalent eAcept for the variale eing
.Aample: > stud4 of a ne! treatment regimen allo!s patients to
choose if the4 receive the ne! treatment or the current standard,
Ko!ever# the ne! treatment regimen ma4 result in urge incontinence,
.lderl4 patients# !ho have a much higher incidence of incontinence# might
enter the standard therap4 arm in higher numers# !hile 4ounger persons
might enter the ne! treatment regimen to otain relief for the disease
eing treated, 2he result might e that patients on the ne! regimen do
etter# if onl4 ecause the4 are on average 4ounger,
Blinding: Blinding prevents intentional and unintentional bias from eing
.Aample: > stud4 is not linded to patients or doctors, Coctors ma4
eAaggerate the e6cac4 of a drug# or patients ma4 have a placeo e=ect
that maDes the ne! drug looD etter than it reall4 is, ^iDe!ise# doctors
ma4 do!npla4 the adverse e=ects of a drug# or patients ma4 under8report
negative e=ects,
Compliance: Zniform adherence to the stud4 protocol is essential to
collecting consistent data,
.Aample: &atients in a clinical trial do not taDe an eAperimental
medication properl4, 9n the case of isphosphonates# this !ould result in
over8reporting of adverse e=ects of esophagitis# a common side e=ect of
Data: &roper methodolog4 must e implemented for data collection and
.Aample: > test is used to evaluate plasma levels of a drug# ut the
test has a !ide margin of error, Stud4 values for e=ective doses might
var4 !idel4# maDing even an e=ective drug di6cult to use due to
uncertaint4 aout its therapeutic !indo!,
<ligiblit#: >ppropriate eligiilit4 criteria eAcludes su<ects !ith Dno!n
confounders# !hile remaining general enough to recruit enough su<ects
for the stud4,
.Aample: > research stud4 is investigating the e6cac4 of a ne!
aerosol steroid preparation on post8nasal drip in patients !ith seasonal
allergies, 2he stud4 !ould !ant to eAclude patients !ho have
comoridities such as gastroesophageal reQuA# !hich can eAacerate
cough, Ko!ever# eAcluding patients !ith comoridities might eAclude so
man4 people that the stud4 !ould not achieve high enough po!er to e
5ollow@up: 9deall4# studies should seeD to have at least a *;) follo!8up
.Aample: > drug causes an allergic t4pe reaction in a small
proportion of su<ects, >=ected patients in a clinical trial of the drug
discontinue its use and are lost to follo!8up, 9f these patients are not
follo!ed up !ith# the adverse e=ect of this drug ma4 go under8reported or
1ower: 2he po!er of a stud4 refers to the liDelihood that the stud4 !ill
re<ect the null h4pothesis !hen it is false, > high po!er (J(;) is
considered su6cient) is needed to achieve internal validit4,
.Aamples: > stud4 has a ver4 small numer of su<ects, Signifcant
results are found# ut the po!er of the stud4 is small# since there is not
actuall4 much data to support it,
:or more information on prolems of eAperimental design# revie! Bias A
:or more information on errors in stud4 conclusions and po!er#
revie! B#potheses and <rrors,
.valuating RisD

Relative RisD measures the e=ect of e"posure on the chances of
developing a disease, .Aample:
W$;) of smoDers develop S5^5: a0(aF)
W") of non8smoDers develop small cell lung cancer: c0(cFd)
Relative risD of cigarette smoDing in the development of S5^5: $;
?dds ratio: useful !hen stud4 design prevents the relative risD from eing
calculated# notal4 the case@control design
9n case control studies# su<ects are chosen 4 outcome# not
2he odds ratio is calculated 4 dividing the odds of `casea eAposure
4 the odds of `controla eAposure,
2he odds ratio gives the liDelihood of the su<ect developing the
adverse outcome as compared to the placeo,
2he ?R approAimates RR onl4 !hen prevalence is low: aF V
>ttriutale RisD

;ttributable risk: 2he risD of an outcome attriutale to a given
>R = 9ncidence in eAposed group ()) Y 9ncidence in uneAposed group ()),
.Aample: > stud4 eAamines the association of stroDes !ith smoDing
cigarettes, 9n the eAposed group (i,e, smoDers)# there is a E;) rate of
stroDes, 9n the non8eAposed group (i,e, non8smoDers)# there is a $;) risD
of stroDes, 2he attriutale risD is $;),
2oddler _ears

"+ months to $,+ 4ears
Social characteristics and ages:
PRapprochementP (child repeatedl4 leaves mother ut returns for
reassurance): "'8$E months
P2errile t!oMsP (favorite !ord is PNoP): $E8%' months
2oilet training: %;8%' months
StacD ' locDs on top of each other: "(8$E months
5lim stairs: $ 4ears
2hro! a all: $ 4ears
&reschooler _ears

$,+ to ' 4ears
&h4sical ailities: LicD a all# alance on one foot: $,+ 4rs
Ride a tric4cle# cop# a line0circle: % 4ears
SticD dra!ings# hop on one foot: E 4ears
2oilet training: % 4ears (P1ee at threeP)
Social characteristics and ages:
Siling rivalr4# nightmares: $,+ to E 4ears
&arallel pla4 (not cooperative# ut share the ph4sical space): $,+ to
E 4ears
9maginar4 friends: E8' 4ears
5ooperative pla4: E8' 4ears
J 30 million Z,S, persons are older than '+ ("$,E) of total population)
&h4sical changes:
@isual S hearing impairment
b muscle mass
b !eight of rain# b cereral lood Qo!
/en: slo!er erection0e<aculation# R refractor4 period, comen:
vaginal dr4ness# vaginal shortening
SeAual interest doesnMt b
&s4chological changes:
Cepression: most common ps4chiatric disorder
Sleep patterns: b quantit4 and qualit4 of sleep
>s humans transition from middle age to old age and e4ond#
learning speed decreases, Ko!ever# intelligence seems to e una=ected
4 the aging process,
Ceath S Bereavement

2he process of d4ing: + Luler8Ross Stages
", Cenial: P2he diagnosis is incorrect,P
$, >nger: PKo! could 4ou let this happen to me[P
%, Bargaining: for eAample# argaining !ith \od
E, Cepression: patient ecomes emotionall4 detached# P9Mm going to
died!hatMs the point[P
+, >cceptance: patient accepts fate
Bereavement is normal grief, 5an e hard to di=erentiate from pathologic
grief0depression, Normal signs include:
Mild sleep disturances# guilt# !eight loss
9llusions are normal
2he most severe s4mptoms should diminish 4 $ months and most
s4mptoms should diminish 4 " 4ear
Signs of pathologic grief:
:eelings of !orthlessness
Suicidal ideation
Severe s4mptoms J $ months

2nCanc# is defned as the period of life from irth to ffteen months,
Bonding and attachment are vital functions in infanc4,
Bonding refers to emotional connection0desire to protect from the
caregiverMs perspective and t4picall4 forms in the frst t!o !eeDs of life,
2he parent must form a ond !ith the infant for infant
survival, 1h#sical contact andemotional connection can enhance the
parentMs ond to the infant
>n4thing that inhiits ph4sical or emotional contact et!een
mother and infant can result in poor ond formation, Neonatal
9espirator# Distress S#ndrome (N9DS* and prematurit# can oth
result in an infant eing ph4sicall4 separated from its mother follo!ing
irth# resulting in poor ond formation,
>n infant must also form an attachment to its primar4 caregiver,
>ttachment refers to a deep emotional connection felt 4 a child to!ards
its caregiver, >ttachment is the chief ps4chological tasD of infanc4,
?lder infants !ho have formed a normal attachment !ill sho! signs
of anAiet4 !hen separated from their mothers,2his is Dno!n as normal
separation an"iet#,
Separation anAiet4 t4picall4 egins around nine months,
&rolonged ph4sical or emotional asence of the mother of an infant
can lead to depression on the part of the infant,
.=ects of long8term ph4sical and emotional neglect from the
primar4 care8giver include failure to thrive# poor language sDills# lacD of
trust# and anaclitic depression (> memor4 device for these e=ects is
`Deak, Dordless, Danting, Dar#a)
2he Diagnostic and Statistical Manual of Mental Disorders 5th
Edition (DSM-5) defnes the attachment disorder that results from grossl4
pathological care as reacti&e attachment disorder (9;D*. 2he infant
!ith R>C usuall4 presents as !ithdra!n and unresponsive,
9nfants develop motor sDills according to a predictale pattern,
>n infant of three months !ould e eApected to e ale to lift its
head !hile in a prone position,
>n infant et!een four and siA months !ould e eApected
to roll o&er# sit unassisted# reach for o<ects# and grasp !ith entire hand
called Epalmar graspE,
>n infant et!een seven and eleven months !ould e eApected
to creep0crawl# pull itself into a standing position# grasp o<ects !ith
thum and forefnger (called `pincer graspa)# and thro! o<ects,
>n infant et!een t!elve and ffteen months !ould e eApected
to walk unassisted,
Social milestones also occur according to a pattern in infants,
>n infant et!een one and three months !ould e eApected
to smile in response to human face,
>n infant et!een four and siA months !ould e eApected to form
an attachment to a primar4 caregiver and recognize familiar people,
Stranger an"iet# is a form of distress sho!n 4 children !hen
eAposed to individuals unfamiliar to them,
>n infant et!een around siA months of age !ould e eApected to
sho! stranger an"iet#,
Separation anAiet4 is a form of distress sho!n 4 children !hen
separated from their primar4 caregiver, >s noted aove# separation
an"iet# is eApected to appear around nine months,
.arl4 language milestones to appear in infants are cooing and gurgling, >n
infant et!een one and three months !ould e eApected to coo or gurgle
in response to attention,
Babbling t4picall4 egins around siA months, Baling is defned
(in this conteAt) as creating vo!el0consonant cominations (mamama#
>n infant et!een seven and eleven months !ould e eApected
to imitate sounds# use gestures (!ave)# and respond to its name,
>n infant et!een t!elve and ffteen months !ould e eApected to
sa4 its frst !ords and understand that o<ects are present !hen hidden,
(this is called `obFect permanencea,)
> group of reQeAes called primitive reQeAes is present in infants7 in normal
infants# all primitive reQeAes disappear 4 one 4ear,
2he palmar grasp reQeA is !hen an infant reQeAivel4 grasps
fngers placed in its hand, 2his t4picall4 disappears around ' months,
2he rooting and sucking reQeA is !hen a childMs head turns
to!ard a cheeD stroDe in search of a nipple to sucD, 2his t4picall4
disappears around ' Y "$ months,
2he moro reGe" is !hen an infantMs arms and legs eAtend !hen
startled, 2his t4picall4 disappears around % months,
2he Babinski reGe" is !hen an infantMs ig toe dorsiQeAes in
response to rushing of the plantar surface of the foot, 2his t4picall4
disappears around ' months,

2here are + tanner stages of development
Stage 9: no puic hair# prepuertal
Stage 99: small amount of puic hair# males R testicular size#
females reast uds form
Stage 999: males R penis size0length# females reast uds elevate
and eAtend e4ond the areola
Stage 9@: adult8qualit4 puic hair# scrotum continues enlarging ut
also darDens# areola and nipple form a secondar# mound
Stage @: adult# areola returns to contour of the reast

&rematurit4 is defned as gestation I %- !eeDs ?R lo! irth !eight
(defned as H 20$$ grams)
>ssociated !ith teenage pregnanc4# poor maternal nutrition
&ostpartum Reactions
&ostpartum PluesP: s4mptoms last I $ !eeD post8deliver4
&ostpartum depression: s4mptoms egin !ithin E !Ds post8deliver4,
&atients feel hopeless# helpless
&ostpartum ps4chosis: s4mptoms egin $8% !Ds post8deliver4,
&atients hallucinate# are delusional# ma4 harm their children
Stud4 24pes
5ase8control stud4
Su<ects are divided into t!o groups: those !ith the disease (cases)
and those !ithout (controls),
Cata is gathered to see ho! man4 cases !ere eAposed to the risD
factor# then ho! man4 controls !ere eAposed# to see if eAposure rates are
increased in those !ith the disease,
2he outcome measured is an odds@ratio,
5ohort studies can e retrospective or prospective
Su<ects are divided into t!o groups: those !ith eAposure to a risD
factor# and those !ithout,
Cata is gathered to see if disease rates are increased in the group
!ith eAposure to the risD factor,
9elati&e risk is the statistical measurement used in cohort studies,
5ross8sectional stud4
Su<ects are asDed aout their risD factors and their disease status,
>ll information is ased on the present status of the su<ects,
2!in concordance stud4
5ompares the frequenc4 that monoz4gotic t!ins oth have a
disease !ith the frequenc4 found in diz4gotic t!ins,
>doption stud4
5ompares outcomes in t!ins that are raised in separate homes,
Bias S Reduction

24pes of Bias: selection# recall# sampling# procedure
Selection bias: Refers to ias introduced 4 the treatment choices
of su<ects, 9n other !ords# if the su<ects are allo!ed to choose !hich
arm of the stud4 (treatment# placeo# no treatment) the4 enter# a ias
ma4 e introduce to the stud4,
.Aample: > group of cancer patients are enrolled in a clinical trial for a
ne! t4rosine Dinase inhiitor, Su<ects !ith more severe prognoses ma4
e more !illing to undergo the eAperimental treatment# !hereas those
!ith etter prognoses ma4 e less !illing to taDe that risD, 2his could
result in an increased mortalit4 and moridit4 rate in the eAperimental
treatment group that is unrelated to the drugMs e6cac4,
Zltimatel4# selection bias is a diIerence between two groups due
to the treatment preCerences oC patients, rather than the clinical
&ariable in Juestion.
9ecall bias: 2he presence of illness ma4 a=ect the su<ectMs
memor4 of their medical histor4,
.Aample: &atients !ith alcoholic liver disease overestimating their past
consumption of alcohol after the4 are told of their diagnosis,
Sampling bias: Su<ects are not representative of the population
eing studied# thus fndings in those su<ects !ould not e valid in the
population eing studied,
.Aample: &eople !ho volunteer for a trial of a ne! anti8smoDing drug ma4
e more motivated than the average smoDer to quit smoDing, 2hus#
fndings amongst this group of unusuall4 motivated people !ould not
appl4 to the smoDing pulic at large,
1rocedure bias: groups arenMt treated the same (e,g, surger4
performed on one group and not another# or a medication is given to one
group ut no placeo is given to the other)
Bias can e reduced 4 linding# randomization# crossover# and placeos
Coule8linded studies: oth su<ect and eAperimenter are linded
to the treatment the su<ect receives
Randomization: su<ects randoml4 assigned to groups7 theoreticall4
ensures that the proportion of sicD su<ects is the same in control vs,
treatment groups
5rossover: \roup > receives treatment and \roup B receives
placeo 3 later in the stud4# \roup > receives placeo and \roup B
receives treatment
&laceo response: e "0% of patients respond to placeos
^evels of .vidence

^evel 9: .vidence otained from at least one properl4 designed
randomized controlled trial
^evel 998": .vidence otained from !ell8designed controlled trials
!ithout randomization
^evel 998$: .vidence otained from !ell8designed cohort or case8
control anal4tic studies# preferal4 from more than one center or research
^evel 999: ?pinions of respected authorities (e,g, eApert committees)
5linical 2rial &hases

5linical trials are eAperiments on humans# usuall4 to test safet4 and
e6cac4 of a ne! drug
&hase ; (PmicrodosingP)
> small numer of health4 su<ects are given a
single subtherapeutic dose to gather preliminar4 pharmacoDinetic and
pharmacod4namic data
9n phase "# a small numer of (normall4 health4) su<ects receive a single
2ests safet4# pharmacoDinetics# and pharmacod4namics
&hase 99
/id8sized groups (a fe! hundred) of patients !ith the disease to e
Cetermines dosing# eKcac## and adverse e=ects
&hase 999
^arge# multicenter trials involving patients !ith the disease to e
5ompares treatment to the current Pgold standardP
&hase 9@
&ost8marDeting surveillance
/edical Bioethics &rinciples

>utonom4: respect for the individual and their ailit4 to maDe their o!n
Benefcence: ph4sicians are oligated to eneft the patient or others
Non8malefcence: actions should not harm or ring harm to patients
fustice: ph4sicians must consider PfairnessP to the communit4 !hen
considering the consequences of an action
9nformed 5onsent

2o give informed consent# patients must e competent and understand
the follo!ing:
2he diagnosis# the treatment in question and alternatives to
treatment (including no treatment at all)# and the risDs F enefts
2he prognosis if he doesnMt consent to the procedure
5onsent can e !ithdra!n at an4 time prior to starting the
Special situation: uneApected fndings (e,g,# an uneApected malignanc4 is
&atient must give consent for an4 additional procedures
Situations that donMt require informed consent:
.mergenc4 procedures (e,g, trauma)
&atient lacDs decision8maDing capacit4
2herapeutic privilege: the patient is ps4chiatricall40emotionall4 too
unstale to handle information required for informed consent
9n these situations# if a healthcare proA4 or legal guardian are
availale# consent should e otained from them
9nformed consent for minors (children I "( 4ears old): &arents must give
consent# eAcept for E situations
", .mergencies
$, &regnanc4 treatment (eAcept aortion)
%, S2C treatment
E, Crug0alcohol dependence treatment
>dvance Cirectives

^iving cill: !ritten document dictating !hat treatments the patient
!ants0doesnMt !ant to receive
Zsuall4 focuses on life8sustaining treatment (e,g, mechanical
ventilation# cardiopulmonar4 resuscitation)
&o!er of >ttorne4: legall4 designates another person to maDe decisions
for the patient if the4 lose decision8maDing capacit4
?ral >dvance Cirective: patientMs statements regarding their !ishes
&rolematic ecause thereMs no record and is open to interpretation
.Aamples: P9 !ould totall4 e an organ donor if 9 died in a car
accident,P or P9 !ould never!ant to e on mechanical ventilation,P
Cefnition of Ceath

Kistoricall4 defned as as4stole 0 cardiac arrest
&rolematic ecause !e can pharmacologicall4 and mechanicall4
Deep the heart pumping (e,g, artifcial pacemaDers)
>lso prolematic ecause defrillation can often return patients
from cardiac arrest (the historic defnition !ould declare the patient dead
too earl4)
Brain death: defned in nationall4 adopted legislation as Pirreversile
cessation of all functions of the entire rain# including the rain stemP
>merican >ssociation of Neurolog4Ms clinical determinants:
") >sent rainstem reQeAes (e,g,# pupillar4# caloric# corneal#
phar4ngeal) and asence of e=ective respirator4 motion in the presence
of adequate oA4genation and h4percapnea (arterial p5?$ of '; mmKg)
K4percapnea maAimizes respirator4 drive
$) 5linical0neuroradiologic evidence of an etiolog4 adequate to
eAplain the clinical fndings (e,g, trauma# uncal herniation)
%) .Aclusion of reversile factors i,e, drug intoAication or od4 core
temperature I *;g: (Pnot dead until !arm and deadP)

&roof of malpractice requires the E CMs
Cereliction (negligence): the ph4sician deviated from the standards
of care
Cut4: the ph4sician had an estalished relationship !ith the patient
(4ou canMt e sued for malpractice 4 a patient 4ou never met)
Camages: the patient harmed
Cirect: the harm !as a direct result of the ph4sicianMs negligence
&unitive damages: requires proof of gross negligence7 meant to deter the
medical communit4 from committing similar reaches
SeAual relationships !ith patients (oth current and former) are a form of
/alpractice cases are <udged in civil court (vs, criminal) 3 di=erent
standard of <udgment
Not Pe4ond a reasonale doutP, 9nstead# the <ur4 simpl4 has to e
convinced that the patientMs claims are liDel4 to e true,
\ood Samaritan ^a!s
^a!s that protect healthcare providers from liailit4 for providing
professional help in emergenc4 situations
\oal: remove a arrier that maDes people reluctant to help strangers for
fear of mistaDes and their legal repercussions
.Aample: a man su=ers a cardiac arrest at the mall in front of a
second84ear medical student# !ho provides 5&R, 9n the process# the4
reaD some ris, 2he student canMt e sued,
\enerall4 doesnMt appl4 to medical professionals0emergenc4 responders
!hen the4 are acting as professionals# eAcept !hen the4 are volunteering
their services
2he la!s var4 from state8to8state# so fner points arenMt tested on
the ZS/^.
&atient 9ntervie!ing# 5onsultation#
.stalishing Rapport

\ood interpersonal and communication sDills are critical to an e=ective
patient intervie!,
2aDing the time to listen helps the patient feel more comfortale,
>llo!ing a moment of silence can encourage a quieter patient to speaD
more and disclose valuale information,
2he est intervie!ers are more focused on helping the patient than
on their o!n needs and !ants,
> De4 principle !hen maDing decisions aout interactions !ith other
professionals and the patientMs famil4 is that 4our frst dut4 is to the
patient# !hich includes respecting their autonom4 and privac4,
&atient permission is not required to share patient information !ith
another professional so long as the reason for doing so is to provide
proper treatment, :or eAample# a famil4 practitioner does not need the
patientMs consent to consult !ith a cardiologist,
&atient permission is required efore sharing information !ith famil4
and friends,
2here are eAceptions to the aove rules aout confdentialit4, :or
details info# revie! our 2opic on Con8dentialit#,
?ne of the De4 responsiilities of a ph4sician is to provide medical
education to the patient and to encourage lifest4le changes that promote
greater health,
.Aplain concepts in a !a4 that the patient can understand, >sD
questions to checD for understanding,
Be careful to not overurden the patient !ith too man4
goals0changes at a time,
Set specifc goals# and follo! up !ith the patient on their progress,
Zse questions from the mnemonic 5;9 CLMD<9 to gather information
aout the patientMs chief complaint
5requenc4 of occurrence
;ssociated s4mptoms
9adiation# meaning radiation of pain to a di=erent area
Character of the s4mptom (e,g, dull vs, sharp pain)
Lnset# or !hen the patient frst noticed the s4mptom
Mocation of the s4mptom
Duration of the s4mptom
<Aacerating factors
9elieving factors
2he ph4sicianMs approach to giving `ad ne!sa a=ects the ailit4 of the
patient and patientMs famil4 to cope !ith and manage their health moving
for!ard, 2he follo!ing sDills can help in such situations:
Be clear and unamiguous !hen communicating information, 2his
ma4 require multiple visits !ith the patient# as the4 ma4 not e ale to
assimilate all 4ou sa4 due to their emotional state,
>ns!er all questions, >sD aout the patientMs immediate needs,
Cepending on the famil4 d4namics# it ma4 e appropriate to have
the patientMs famil4 memers present,
?=er hope and help !hile eing completel4 honest aout the
patientMs prognosis,
5lose the intervie! 4 maDing plans for the near future,
9n so8called Pdi6cultP intervie!s such as !ith a silent# angr4# or
demanding patient# often the est thing is to calml4 asD the patient to
eAplain !h4 the4 feel the !a4 the4 do (`_ou appear angr4, 9s there a
reason !h4[a),
&h4sicians frequentl4 assume the patient is upset !ith them# !hen
more often it is someone or something else that is causing the patientMs
negative feelings, B4 discussing the prolem !ith them# 4ou are no! on
their PsideP and the4 are more !illing to trust 4ou,
9f the arriers to e=ective communication and treatment are
signifcant and not ale to e resolved# it ma4 e appropriate to refer the
patient to someone else,
> patientMs cultural0ethnic acDground impacts their decisions regarding
health care,
9t is important to respect a patientMs eliefs and preferences,
5are should e taDen to not falsel4 assume a patient has a certain
set of eliefs and preferences ased on their race or acDground ecause
if false# those assumptions could e a arrier to optimal care,

&h4sicians must Deep patient confdentialit4
5odifed in "**' K9&>> rules (federal la!)
.Aceptions: 2araso= decision and some situations !here persons are
"*-' 2araso= decision: mental health practitioners can reach
confdentialit4 to !arn intended victims if their patients threaten harm
.Aample threatened8persons situations (!here the 2araso= decision
can appl4): child ause# life8threatening situations# K9@F patients !ho
have unprotected seA
Sleep Cisorders
Sleep apnea: patient stops reathing during sleep
RisD factors: oesit4# elderl4
5entral sleep apnea: lacD respirator4 drive,
?structive sleep apnea: characterized 4 snoring7 often due to oesit4
(!eight of necDMs soft tissues)
&atients are chronicall4 tired ecause the4 canMt get deep sleep7
anoAia a!aDens them dozens of times to reathe
9nsomnia: di6cult4 falling asleep or sta4ing asleep
"84ear prevalence in ZS adults: ";8"+)
>ssociated !ith anAiet4 and situational stress
Narcoleps4: Psleep attacDsP !here patients suddenl4 fall asleep
2rue R./ sleep during these attacDs
/a4 involve catapleA4# !here the patient loses all muscle tone upon
startling0sneezing 3 collapses to the ground
2his is caused 4 loss of h4pocretin0oreAin producing neurons,
/a4 include h4pnagogic (<ust efore sleeping) and h4pnopompic
(occur during a!aDening) hallucinations
2reat !ith stimulants
Night terrors: patient a!aDes terrifed ut has no memor4 of dreaming
Zsuall4 occur in children
2aDe place during non8R./ (NR./) stage N% sleephin the >merican
>cadem4 of Sleep /edicine (>>S/# $;;-) sleep8staging s4stem i!hich
corresponds to stages % and E of the older Rechtscha=en and Lales (RSL)
s4stem ("*'()j
?ver!eight S ?esit4

/ost commonl4 defned 4 B/9 (od48mass8indeA)
ceight (Dg) 0 Keight
?ver!eight = B/9 $+,; to $*,*
?esit4 = B/9 J %;,;, 9n $;;'# aout %%) of ZS adults !ere oese
ZS ?esit4 2rends
SeAual C4sfunction

Ci=erential: ph4sical vs, ps4chological
&h4sical causes include diaetes0vascular disease# neurologic disorders#
endocrine d4sfunction# alcoholism0drug ause
&s4chological causes include stress and anAiet4 (including performance
anAiet4)# depression# histor4 of seAual trauma

>!aDe state: >lpha and Beta !aves
Beta !aves are most strongl4 associated !ith active thinDing and
>lpha !aves occur during a!aDe# relaAed (not concentrating) states
Sleep: R./ (rapid e4e movement) vs, non8R./ stages
R./ sleep: Psa!toothP !aves7 eta# alpha# and theta !aves also present
5haracterized 4 dreaming# penile0clitoral erections# R pulse and
B&# loss of motor tone
R./ t4picall4 lasts for ";8E; minutes and occur ever4 /$ minutes
2he e4e movements are driven 4 the &&R: (paramedian pontine
reticular formation)
Non8R./ (NR./) stage N" sleeph>merican >cadem4 of Sleep /edicine
(>>S/)# $;;-: the lightest state
5haracterized 4 b pulse0respirator4 rate0lood pressure
Non8R./ (NR./) stage N$ sleep (>>S/# $;;-): deeper than stage "
5omprises the greatest percent of sleep time (WE+) in 4oung
^ooD for L8compleAes and sleep spindles
Non8R./ (NR./) stage N% sleephin the >>S/ sleep staging s4stem
($;;-) istages % and E of the old Rechtscha=en and Lales (RSL) s4stem
("*'()j: the deepest# most relaAed part of sleep
Night terrors# sleep!alDing# enuresis occur during stage N% sleep
Stage N% sleep is characterized 4 delta !aves (slo! !aves)
Reportale Ciseases
Some diseases are reportale nationall4 (in ever4 state)
S2Cs: K9@# 5hlam4dia trachomatis# Neisseria gonorrhea# S4philis
2oAin8ased diseases: anthraA# otulinism
>roviruses (St, ^ouis encephalitis virus# cest Nile virus# etc)
Kepatitis > S B# chicDenpoA
@accined diseases: mumps# measles# ruella
5auses of Ceath

/ost common causes of death in the Znited States# ased on
$;;( 5C5 data:
L&erall most common causes oC death (i.e., combining all age
", Beart disease
$, /alignant neoplasms
%, 5hronic lo!er respirator4 disease
E, 5ererovascular disease
+, Znintentional in<ur4
', >lzheimer disease
-, Ciaetes mellitus
(, 9nQuenza S pneumonia
*, Nephritis
";, Suicide
I" 4ear of age:
", Congenital anomalies
$, Short gestation
%, S9CS (sudden infant death s4ndrome)
E, /aternal pregnanc4 complications
+, Znintentional in<ur4
"8E 4ears of age:
", Nnintentional inFur#
$, 5ongenital anomalies
%, Komicide
E, /alignant neoplasms
+, Keart disease
+8* 4ears of age:
", Nnintentional inFur#
$, /alignant neoplasms
%, 5ongenital anomalies
E, Komicide
+, Keart disease
";8"E 4ears of age:
", Nnintentional inFur#
$, /alignant neoplasms
%, Suicide
E, Komicide
+, 5ongenital anomalies
', Keart disease
"+8$E 4ears of age:
", Nnintentional inFur#
$, Komicide
%, Suicide
E, /alignant neoplasm
+, Keart disease
$+8%E 4ears of age:
", Nnintentional inFur#
$, Suicide
%, Komicide
E, /alignant neoplasms
+, Keart disease
', K9@
%+8EE 4ears of age:
", Nnintentional inFur#
$, /alignant neoplasms
%, Keart disease
E, Suicide
+, Komicide
', K9@
-, ^iver disease
E+8'E 4ears of age:
", Malignant neoplasms
$, Keart disease
%, Znintentional in<ur4
E, 5hronic lo!er respirator4 disease
+, Ciaetes mellitus
', ^iver disease
J '+ 4ears of age:
", Beart disease
$, /alignant neoplasms
%, 5hronic lo!er respirator4 disease
E, 5ererovascular disease
+, >lzheimer disease
/edicare vs, /edicaid
:ederal social insurance programs
/edicare functions as a single8pa4er health care s4stem
/edicare &art >: covers hospital fees
/edicare &art B: covers ph4sician services (e,g, outpatient)#
diagnostic tests
/edicare &art 5: allo!s /edicare recipients to receive their enefts
through private health insurance plans
/edicare &art C: &rescription drug plans (passed into la! in $;;')
/edicaid: for lo! income families0individuals
Cisease &revention

&rimar4 prevents disease from occurring: seatelt la!s (prevents
traumatic in<uries)# vaccinations
Secondar4 prevention relies on earl4 detection of disease process
and susequent interventions to prevent progression: screening
adominal ultrasounds in male smoDers (looDing for adominal aortic
2ertiar4 prevents late e=ects of disease: anticoagulation in patients
!ith deep vein thromoses (prevents pulmonar4 emolus)
9mportant &reventive /easures:
:oot eAams in diaetics
K9@ and 2B testing in drug users
&neumococcal S inQuenza vaccinations in elderl4 and
S2C testing in high8risD patients (e,g, seA !orDers