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OBG Management is a leading publication in the ObGyn specialty addressing patient care and practice management under one cover.
gambling
compulsive behaviors
ammunition
assault rifle
black jack
Boko Haram
bondage
child abuse
cocaine
Daech
drug paraphernalia
explosion
gun
human trafficking
ISIL
ISIS
Islamic caliphate
Islamic state
mixed martial arts
MMA
molestation
national rifle association
NRA
nsfw
pedophile
pedophilia
poker
porn
pornography
psychedelic drug
recreational drug
sex slave rings
slot machine
terrorism
terrorist
Texas hold 'em
UFC
substance abuse
abuseed
abuseer
abusees
abuseing
abusely
abuses
aeolus
aeolused
aeoluser
aeoluses
aeolusing
aeolusly
aeoluss
ahole
aholeed
aholeer
aholees
aholeing
aholely
aholes
alcohol
alcoholed
alcoholer
alcoholes
alcoholing
alcoholly
alcohols
allman
allmaned
allmaner
allmanes
allmaning
allmanly
allmans
alted
altes
alting
altly
alts
analed
analer
anales
analing
anally
analprobe
analprobeed
analprobeer
analprobees
analprobeing
analprobely
analprobes
anals
anilingus
anilingused
anilinguser
anilinguses
anilingusing
anilingusly
anilinguss
anus
anused
anuser
anuses
anusing
anusly
anuss
areola
areolaed
areolaer
areolaes
areolaing
areolaly
areolas
areole
areoleed
areoleer
areolees
areoleing
areolely
areoles
arian
arianed
arianer
arianes
arianing
arianly
arians
aryan
aryaned
aryaner
aryanes
aryaning
aryanly
aryans
asiaed
asiaer
asiaes
asiaing
asialy
asias
ass
ass hole
ass lick
ass licked
ass licker
ass lickes
ass licking
ass lickly
ass licks
assbang
assbanged
assbangeded
assbangeder
assbangedes
assbangeding
assbangedly
assbangeds
assbanger
assbanges
assbanging
assbangly
assbangs
assbangsed
assbangser
assbangses
assbangsing
assbangsly
assbangss
assed
asser
asses
assesed
asseser
asseses
assesing
assesly
assess
assfuck
assfucked
assfucker
assfuckered
assfuckerer
assfuckeres
assfuckering
assfuckerly
assfuckers
assfuckes
assfucking
assfuckly
assfucks
asshat
asshated
asshater
asshates
asshating
asshatly
asshats
assholeed
assholeer
assholees
assholeing
assholely
assholes
assholesed
assholeser
assholeses
assholesing
assholesly
assholess
assing
assly
assmaster
assmastered
assmasterer
assmasteres
assmastering
assmasterly
assmasters
assmunch
assmunched
assmuncher
assmunches
assmunching
assmunchly
assmunchs
asss
asswipe
asswipeed
asswipeer
asswipees
asswipeing
asswipely
asswipes
asswipesed
asswipeser
asswipeses
asswipesing
asswipesly
asswipess
azz
azzed
azzer
azzes
azzing
azzly
azzs
babeed
babeer
babees
babeing
babely
babes
babesed
babeser
babeses
babesing
babesly
babess
ballsac
ballsaced
ballsacer
ballsaces
ballsacing
ballsack
ballsacked
ballsacker
ballsackes
ballsacking
ballsackly
ballsacks
ballsacly
ballsacs
ballsed
ballser
ballses
ballsing
ballsly
ballss
barf
barfed
barfer
barfes
barfing
barfly
barfs
bastard
bastarded
bastarder
bastardes
bastarding
bastardly
bastards
bastardsed
bastardser
bastardses
bastardsing
bastardsly
bastardss
bawdy
bawdyed
bawdyer
bawdyes
bawdying
bawdyly
bawdys
beaner
beanered
beanerer
beaneres
beanering
beanerly
beaners
beardedclam
beardedclamed
beardedclamer
beardedclames
beardedclaming
beardedclamly
beardedclams
beastiality
beastialityed
beastialityer
beastialityes
beastialitying
beastialityly
beastialitys
beatch
beatched
beatcher
beatches
beatching
beatchly
beatchs
beater
beatered
beaterer
beateres
beatering
beaterly
beaters
beered
beerer
beeres
beering
beerly
beeyotch
beeyotched
beeyotcher
beeyotches
beeyotching
beeyotchly
beeyotchs
beotch
beotched
beotcher
beotches
beotching
beotchly
beotchs
biatch
biatched
biatcher
biatches
biatching
biatchly
biatchs
big tits
big titsed
big titser
big titses
big titsing
big titsly
big titss
bigtits
bigtitsed
bigtitser
bigtitses
bigtitsing
bigtitsly
bigtitss
bimbo
bimboed
bimboer
bimboes
bimboing
bimboly
bimbos
bisexualed
bisexualer
bisexuales
bisexualing
bisexually
bisexuals
bitch
bitched
bitcheded
bitcheder
bitchedes
bitcheding
bitchedly
bitcheds
bitcher
bitches
bitchesed
bitcheser
bitcheses
bitchesing
bitchesly
bitchess
bitching
bitchly
bitchs
bitchy
bitchyed
bitchyer
bitchyes
bitchying
bitchyly
bitchys
bleached
bleacher
bleaches
bleaching
bleachly
bleachs
blow job
blow jobed
blow jober
blow jobes
blow jobing
blow jobly
blow jobs
blowed
blower
blowes
blowing
blowjob
blowjobed
blowjober
blowjobes
blowjobing
blowjobly
blowjobs
blowjobsed
blowjobser
blowjobses
blowjobsing
blowjobsly
blowjobss
blowly
blows
boink
boinked
boinker
boinkes
boinking
boinkly
boinks
bollock
bollocked
bollocker
bollockes
bollocking
bollockly
bollocks
bollocksed
bollockser
bollockses
bollocksing
bollocksly
bollockss
bollok
bolloked
bolloker
bollokes
bolloking
bollokly
bolloks
boner
bonered
bonerer
boneres
bonering
bonerly
boners
bonersed
bonerser
bonerses
bonersing
bonersly
bonerss
bong
bonged
bonger
bonges
bonging
bongly
bongs
boob
boobed
boober
boobes
boobies
boobiesed
boobieser
boobieses
boobiesing
boobiesly
boobiess
boobing
boobly
boobs
boobsed
boobser
boobses
boobsing
boobsly
boobss
booby
boobyed
boobyer
boobyes
boobying
boobyly
boobys
booger
boogered
boogerer
boogeres
boogering
boogerly
boogers
bookie
bookieed
bookieer
bookiees
bookieing
bookiely
bookies
bootee
booteeed
booteeer
booteees
booteeing
booteely
bootees
bootie
bootieed
bootieer
bootiees
bootieing
bootiely
booties
booty
bootyed
bootyer
bootyes
bootying
bootyly
bootys
boozeed
boozeer
boozees
boozeing
boozely
boozer
boozered
boozerer
boozeres
boozering
boozerly
boozers
boozes
boozy
boozyed
boozyer
boozyes
boozying
boozyly
boozys
bosomed
bosomer
bosomes
bosoming
bosomly
bosoms
bosomy
bosomyed
bosomyer
bosomyes
bosomying
bosomyly
bosomys
bugger
buggered
buggerer
buggeres
buggering
buggerly
buggers
bukkake
bukkakeed
bukkakeer
bukkakees
bukkakeing
bukkakely
bukkakes
bull shit
bull shited
bull shiter
bull shites
bull shiting
bull shitly
bull shits
bullshit
bullshited
bullshiter
bullshites
bullshiting
bullshitly
bullshits
bullshitsed
bullshitser
bullshitses
bullshitsing
bullshitsly
bullshitss
bullshitted
bullshitteded
bullshitteder
bullshittedes
bullshitteding
bullshittedly
bullshitteds
bullturds
bullturdsed
bullturdser
bullturdses
bullturdsing
bullturdsly
bullturdss
bung
bunged
bunger
bunges
bunging
bungly
bungs
busty
bustyed
bustyer
bustyes
bustying
bustyly
bustys
butt
butt fuck
butt fucked
butt fucker
butt fuckes
butt fucking
butt fuckly
butt fucks
butted
buttes
buttfuck
buttfucked
buttfucker
buttfuckered
buttfuckerer
buttfuckeres
buttfuckering
buttfuckerly
buttfuckers
buttfuckes
buttfucking
buttfuckly
buttfucks
butting
buttly
buttplug
buttpluged
buttpluger
buttpluges
buttpluging
buttplugly
buttplugs
butts
caca
cacaed
cacaer
cacaes
cacaing
cacaly
cacas
cahone
cahoneed
cahoneer
cahonees
cahoneing
cahonely
cahones
cameltoe
cameltoeed
cameltoeer
cameltoees
cameltoeing
cameltoely
cameltoes
carpetmuncher
carpetmunchered
carpetmuncherer
carpetmuncheres
carpetmunchering
carpetmuncherly
carpetmunchers
cawk
cawked
cawker
cawkes
cawking
cawkly
cawks
chinc
chinced
chincer
chinces
chincing
chincly
chincs
chincsed
chincser
chincses
chincsing
chincsly
chincss
chink
chinked
chinker
chinkes
chinking
chinkly
chinks
chode
chodeed
chodeer
chodees
chodeing
chodely
chodes
chodesed
chodeser
chodeses
chodesing
chodesly
chodess
clit
clited
cliter
clites
cliting
clitly
clitoris
clitorised
clitoriser
clitorises
clitorising
clitorisly
clitoriss
clitorus
clitorused
clitoruser
clitoruses
clitorusing
clitorusly
clitoruss
clits
clitsed
clitser
clitses
clitsing
clitsly
clitss
clitty
clittyed
clittyer
clittyes
clittying
clittyly
clittys
cocain
cocaine
cocained
cocaineed
cocaineer
cocainees
cocaineing
cocainely
cocainer
cocaines
cocaining
cocainly
cocains
cock
cock sucker
cock suckered
cock suckerer
cock suckeres
cock suckering
cock suckerly
cock suckers
cockblock
cockblocked
cockblocker
cockblockes
cockblocking
cockblockly
cockblocks
cocked
cocker
cockes
cockholster
cockholstered
cockholsterer
cockholsteres
cockholstering
cockholsterly
cockholsters
cocking
cockknocker
cockknockered
cockknockerer
cockknockeres
cockknockering
cockknockerly
cockknockers
cockly
cocks
cocksed
cockser
cockses
cocksing
cocksly
cocksmoker
cocksmokered
cocksmokerer
cocksmokeres
cocksmokering
cocksmokerly
cocksmokers
cockss
cocksucker
cocksuckered
cocksuckerer
cocksuckeres
cocksuckering
cocksuckerly
cocksuckers
coital
coitaled
coitaler
coitales
coitaling
coitally
coitals
commie
commieed
commieer
commiees
commieing
commiely
commies
condomed
condomer
condomes
condoming
condomly
condoms
coon
cooned
cooner
coones
cooning
coonly
coons
coonsed
coonser
coonses
coonsing
coonsly
coonss
corksucker
corksuckered
corksuckerer
corksuckeres
corksuckering
corksuckerly
corksuckers
cracked
crackwhore
crackwhoreed
crackwhoreer
crackwhorees
crackwhoreing
crackwhorely
crackwhores
crap
craped
craper
crapes
craping
craply
crappy
crappyed
crappyer
crappyes
crappying
crappyly
crappys
cum
cumed
cumer
cumes
cuming
cumly
cummin
cummined
cumminer
cummines
cumming
cumminged
cumminger
cumminges
cumminging
cummingly
cummings
cummining
cumminly
cummins
cums
cumshot
cumshoted
cumshoter
cumshotes
cumshoting
cumshotly
cumshots
cumshotsed
cumshotser
cumshotses
cumshotsing
cumshotsly
cumshotss
cumslut
cumsluted
cumsluter
cumslutes
cumsluting
cumslutly
cumsluts
cumstain
cumstained
cumstainer
cumstaines
cumstaining
cumstainly
cumstains
cunilingus
cunilingused
cunilinguser
cunilinguses
cunilingusing
cunilingusly
cunilinguss
cunnilingus
cunnilingused
cunnilinguser
cunnilinguses
cunnilingusing
cunnilingusly
cunnilinguss
cunny
cunnyed
cunnyer
cunnyes
cunnying
cunnyly
cunnys
cunt
cunted
cunter
cuntes
cuntface
cuntfaceed
cuntfaceer
cuntfacees
cuntfaceing
cuntfacely
cuntfaces
cunthunter
cunthuntered
cunthunterer
cunthunteres
cunthuntering
cunthunterly
cunthunters
cunting
cuntlick
cuntlicked
cuntlicker
cuntlickered
cuntlickerer
cuntlickeres
cuntlickering
cuntlickerly
cuntlickers
cuntlickes
cuntlicking
cuntlickly
cuntlicks
cuntly
cunts
cuntsed
cuntser
cuntses
cuntsing
cuntsly
cuntss
dago
dagoed
dagoer
dagoes
dagoing
dagoly
dagos
dagosed
dagoser
dagoses
dagosing
dagosly
dagoss
dammit
dammited
dammiter
dammites
dammiting
dammitly
dammits
damn
damned
damneded
damneder
damnedes
damneding
damnedly
damneds
damner
damnes
damning
damnit
damnited
damniter
damnites
damniting
damnitly
damnits
damnly
damns
dick
dickbag
dickbaged
dickbager
dickbages
dickbaging
dickbagly
dickbags
dickdipper
dickdippered
dickdipperer
dickdipperes
dickdippering
dickdipperly
dickdippers
dicked
dicker
dickes
dickface
dickfaceed
dickfaceer
dickfacees
dickfaceing
dickfacely
dickfaces
dickflipper
dickflippered
dickflipperer
dickflipperes
dickflippering
dickflipperly
dickflippers
dickhead
dickheaded
dickheader
dickheades
dickheading
dickheadly
dickheads
dickheadsed
dickheadser
dickheadses
dickheadsing
dickheadsly
dickheadss
dicking
dickish
dickished
dickisher
dickishes
dickishing
dickishly
dickishs
dickly
dickripper
dickrippered
dickripperer
dickripperes
dickrippering
dickripperly
dickrippers
dicks
dicksipper
dicksippered
dicksipperer
dicksipperes
dicksippering
dicksipperly
dicksippers
dickweed
dickweeded
dickweeder
dickweedes
dickweeding
dickweedly
dickweeds
dickwhipper
dickwhippered
dickwhipperer
dickwhipperes
dickwhippering
dickwhipperly
dickwhippers
dickzipper
dickzippered
dickzipperer
dickzipperes
dickzippering
dickzipperly
dickzippers
diddle
diddleed
diddleer
diddlees
diddleing
diddlely
diddles
dike
dikeed
dikeer
dikees
dikeing
dikely
dikes
dildo
dildoed
dildoer
dildoes
dildoing
dildoly
dildos
dildosed
dildoser
dildoses
dildosing
dildosly
dildoss
diligaf
diligafed
diligafer
diligafes
diligafing
diligafly
diligafs
dillweed
dillweeded
dillweeder
dillweedes
dillweeding
dillweedly
dillweeds
dimwit
dimwited
dimwiter
dimwites
dimwiting
dimwitly
dimwits
dingle
dingleed
dingleer
dinglees
dingleing
dinglely
dingles
dipship
dipshiped
dipshiper
dipshipes
dipshiping
dipshiply
dipships
dizzyed
dizzyer
dizzyes
dizzying
dizzyly
dizzys
doggiestyleed
doggiestyleer
doggiestylees
doggiestyleing
doggiestylely
doggiestyles
doggystyleed
doggystyleer
doggystylees
doggystyleing
doggystylely
doggystyles
dong
donged
donger
donges
donging
dongly
dongs
doofus
doofused
doofuser
doofuses
doofusing
doofusly
doofuss
doosh
dooshed
doosher
dooshes
dooshing
dooshly
dooshs
dopeyed
dopeyer
dopeyes
dopeying
dopeyly
dopeys
douchebag
douchebaged
douchebager
douchebages
douchebaging
douchebagly
douchebags
douchebagsed
douchebagser
douchebagses
douchebagsing
douchebagsly
douchebagss
doucheed
doucheer
douchees
doucheing
douchely
douches
douchey
doucheyed
doucheyer
doucheyes
doucheying
doucheyly
doucheys
drunk
drunked
drunker
drunkes
drunking
drunkly
drunks
dumass
dumassed
dumasser
dumasses
dumassing
dumassly
dumasss
dumbass
dumbassed
dumbasser
dumbasses
dumbassesed
dumbasseser
dumbasseses
dumbassesing
dumbassesly
dumbassess
dumbassing
dumbassly
dumbasss
dummy
dummyed
dummyer
dummyes
dummying
dummyly
dummys
dyke
dykeed
dykeer
dykees
dykeing
dykely
dykes
dykesed
dykeser
dykeses
dykesing
dykesly
dykess
erotic
eroticed
eroticer
erotices
eroticing
eroticly
erotics
extacy
extacyed
extacyer
extacyes
extacying
extacyly
extacys
extasy
extasyed
extasyer
extasyes
extasying
extasyly
extasys
fack
facked
facker
fackes
facking
fackly
facks
fag
faged
fager
fages
fagg
fagged
faggeded
faggeder
faggedes
faggeding
faggedly
faggeds
fagger
fagges
fagging
faggit
faggited
faggiter
faggites
faggiting
faggitly
faggits
faggly
faggot
faggoted
faggoter
faggotes
faggoting
faggotly
faggots
faggs
faging
fagly
fagot
fagoted
fagoter
fagotes
fagoting
fagotly
fagots
fags
fagsed
fagser
fagses
fagsing
fagsly
fagss
faig
faiged
faiger
faiges
faiging
faigly
faigs
faigt
faigted
faigter
faigtes
faigting
faigtly
faigts
fannybandit
fannybandited
fannybanditer
fannybandites
fannybanditing
fannybanditly
fannybandits
farted
farter
fartes
farting
fartknocker
fartknockered
fartknockerer
fartknockeres
fartknockering
fartknockerly
fartknockers
fartly
farts
felch
felched
felcher
felchered
felcherer
felcheres
felchering
felcherly
felchers
felches
felching
felchinged
felchinger
felchinges
felchinging
felchingly
felchings
felchly
felchs
fellate
fellateed
fellateer
fellatees
fellateing
fellately
fellates
fellatio
fellatioed
fellatioer
fellatioes
fellatioing
fellatioly
fellatios
feltch
feltched
feltcher
feltchered
feltcherer
feltcheres
feltchering
feltcherly
feltchers
feltches
feltching
feltchly
feltchs
feom
feomed
feomer
feomes
feoming
feomly
feoms
fisted
fisteded
fisteder
fistedes
fisteding
fistedly
fisteds
fisting
fistinged
fistinger
fistinges
fistinging
fistingly
fistings
fisty
fistyed
fistyer
fistyes
fistying
fistyly
fistys
floozy
floozyed
floozyer
floozyes
floozying
floozyly
floozys
foad
foaded
foader
foades
foading
foadly
foads
fondleed
fondleer
fondlees
fondleing
fondlely
fondles
foobar
foobared
foobarer
foobares
foobaring
foobarly
foobars
freex
freexed
freexer
freexes
freexing
freexly
freexs
frigg
frigga
friggaed
friggaer
friggaes
friggaing
friggaly
friggas
frigged
frigger
frigges
frigging
friggly
friggs
fubar
fubared
fubarer
fubares
fubaring
fubarly
fubars
fuck
fuckass
fuckassed
fuckasser
fuckasses
fuckassing
fuckassly
fuckasss
fucked
fuckeded
fuckeder
fuckedes
fuckeding
fuckedly
fuckeds
fucker
fuckered
fuckerer
fuckeres
fuckering
fuckerly
fuckers
fuckes
fuckface
fuckfaceed
fuckfaceer
fuckfacees
fuckfaceing
fuckfacely
fuckfaces
fuckin
fuckined
fuckiner
fuckines
fucking
fuckinged
fuckinger
fuckinges
fuckinging
fuckingly
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Informed consent: The more you know, the more you and your patient are protected
CASE: Surgeon accused of performing tubal ligation without consent
A patient was scheduled for an elective cesarean delivery to be performed by her ObGyn (Dr. Surgeon) at the nearby medical center. The patient was asked to sign an electronic signature pad in her ObGyn’s office, which transposed her signature onto an electronic form that she could not see at the time. She signed it. The consent was not printed out in the office but was added to her electronic medical record, and a copy was sent to her via email. Among other things, the consent included, “[Name] hereby agrees that all appropriate medical and surgical procedures as determined by the physicians and others in this hospital are in my best interest. No further consent is required to any of the treatment in this hospital.”
In the hospital, Dr. Surgeon spoke preoper- atively with the patient about cesarean delivery, the various risks and benefits, and the possibility and risks of an alternative trial of labor. Dr. Surgeon noted the conversation in the patient’s chart.
A nurse brought a standard hard copy “Zee Hospital Surgical Consent Form” to the patient. In a relevant part it provided, “I hereby consent to the surgical procedure Dr. Surgeon has discussed with me: _______” (the blank was filled in with “cesarean delivery”). The form continued: “He/She has explained the risks and benefits. I also authorize Dr. Surgeon, and such assistants as he/she may select, to perform this procedure. In his/her medical judgment, if additional procedures are appropriate, I hereby consent to their performance, in addition to the procedures listed in this form.” The patient signed the form.
While Dr. Surgeon was scrubbing for the delivery, the patient’s husband (also a surgeon at the hospital; Dr. Husband), stopped by, thanked Dr. Surgeon, and said, “Oh, by the way, my wife would like you to do a tubal ligation as well—she really wants it for health reasons. Her chronic hypertension skyrocketed during this pregnancy, and we don’t want any more children.”
“She didn’t mention that a little earlier while I was talking with her,” replied Dr. Surgeon, “but I can see how it would have slipped her mind.”
Dr. Surgeon performed the cesarean delivery and tubal ligation. All went well, with a healthy baby and mother. Several months later, the patient and Dr. Husband separated and sought divorce.
The patient, surprised by the cost of the hospital bill (Dr. Surgeon did not bill for his surgical services as a professional courtesy), was astonished to see a charge related to tubal ligation. Knowing how common billing mistakes were at Zee Hospital, she called to have the bill corrected. The clerk informed her that her medical record showed that a tubal ligation had been performed and that the bill was correct.
The patient sued Dr. Surgeon, Zee Hospital, and her (now former) husband, Dr. Husband, both for the cesarean delivery and the tubal ligation. Her claims are primarily based on the lack of informed consent.
What’s the verdict?
The patient likely has a strong case regarding the tubal ligation claim, but a weak case related to the cesarean delivery claim.
Read the ethical, medical, and legal implications of this case
Ethical and medical considerations
Although this case seems too strange for fiction, the basic facts are taken from events that did occur at a major institution. The puzzling features of this case are meant to be a cautionary tale: it is easy in the rush with the pressure of clinical practice to view informed consent as a bothersome technical detail. Yet as the following discussion suggests, adhering closely to the tenets of informed consent protects not only the fundamental interests of the patient but also the physicians and medical institutions.
Informed consent serves as protective communication
Informed consent at its core is a “process of communication” that involves you as the health care provider and the patient. It provides authority for an activity based upon an understanding of what that activity entails.1,2 Aspects of informed consent, from the physician−patient perspective, include the following:
- disclosure
- comprehension
- voluntary choice
- authorization.
In one other sense, informed consent is based on a fiduciary relationship between the ObGyn and patient.3 Overall, the process consists of an educational communication by the physician to the patient. Ideally, providers perceive the process from an ethical point of view that has been formalized by cases and statutes.4
Informed consent protects one of the most basic values of medicine and society: autonomy. From the perspective of moral philosophers, the principle of autonomy establishes the moral right to choose and follow one’s own plan for life and action.5,6 For ObGyns, the patient’s autonomy and her ability to participate in the medical decision-making process is of paramount importance. Informed consent is also a reflection of trust inherent to the physician−patient relationship.4
Informed consent is too often viewed as a mere legal formality. In truth, it melds legal and ethical values and concerns. The President’s Commission reflected this, noting that informed consent is rooted in “the fundamental recognition that adults are entitled to accept or reject health care intervention(s) on the basis of their own personal values and in furtherance of their own personal goals.”7
The historic perspective of informed consent dates back to Egyptian, Greek, and Roman eras. Dhar and Dhar suggest that the concept of “physicians’ love for humanity—philantropia” dates back to Plato and is complemented by the term “philotechnia” (love of medicine), all of which have evolved into today’s use of the terms “risks, benefits, and alternatives.”8
We emphasize that informed consent is much more than a legal concept. It has strong clinical roots because it provides an opportunity for physicians to improve communication with their patients. Informed consent is not a form; it is a process to be taken seriously.
Legal principles of informed consent
The famous New York case of Mary Schloendorff v. Society of New York Hospital, in 1914, heralded a principle that remains central in American law. Justice Benjamin Cardozo, writing for the majority, held that, “Every human being of adult years and sound mind has a right to determine what shall be done with his own body; and a surgeon who performs an operation without his patient’s consent commits an assault for which he is liable in damages.”9 The surgeon in the Schloendorff case had undertaken a gynecologic procedure—removal of a fibroid tumor—without patient consent. (In that case the hospital rather than the physician was sued, but the principle clearly applied to the physician.)
Over the last century, the American law of informed consent has developed in a number of ways.10 Lack of informed consent is now almost always considered a form of negligence rather than an intentional tort of battery. The details of the legal requirements vary from state to state as a result of statutory changes and court decisions. But in one way or another, to be “informed,” consent generally must include 4 things:
- a description of the procedure or intervention that is proposed
- the risks and benefits of the proposal—the focus here is generally on the risks of the treatment
- alternatives, if there are any (eg, pharmacologic vs surgical treatment)
- the consequences of not undertaking the proposed treatment (eg, the refusal to have a Papanicolaou smear).
A fifth point might be added—the offer to answer any questions or provide additional information.
These 4 or 5 basic items and the expanded list are efforts to simply describe the information that a reasonable person would need in order to make a decision that represents the patient’s values, personality, and preferences. (Informed consent is in some ways an ongoing process—since a patient may withdraw his/her consent.)
Exceptions to the informed consent requirement
Before turning to the facts in the hypothetical case, it is worth noting that there are 2 common exceptions to the informed consent requirement. The first is an emergency exception. When someone requires immediate attention and the patient is not conscious or capable of consent (nor is a “next of kin” available), treatment may proceed.
The second is therapeutic exception. Its designation is narrow, and it is risky to rely on it except in extreme circumstances. But when the very process of informing the patient of all the risks of a proposed treatment would create significant additional risks for the patient, the consent process may be modified. For example, for an extremely suggestable patient, describing certain risks might, in a psychosomatic way, cause the risk to be realized. In such cases, the record must be clearly documented. It is generally best to discuss the matter with a family member or other surrogate decision maker.
Read what went wrong in this case
What went wrong with consent in this case?
Our case illustrates a number of problems that occur when informed consent is not properly completed.
The electronic signature on the broadly stated consent form the patient initially signed in the office was nearly useless. She did not know what she was signing, did not have any chance to read it before signing, and was provided no help with any of the information factors of informed consent.
The surgical consent form is among the most interesting elements of this case. The form itself was seriously flawed because it contained no real evidence that the patient received information about the risks and alternatives. If the form is all there was, it would be a problem. But the conversation that Dr. Surgeon documented with the patient seemed to provide the basic elements of informed consent, including discussion of risks and benefits.
Oral informed consent is recognized in most states. To his credit, Dr. Surgeon appropriately recorded the conversation in the record. The risk of oral informed consent not backed up by text signature is that, if a dispute arises about the consent, it is difficult to prove details of what was said. (There was, of course, no such dispute about the cesarean delivery as it turned out in this case.)
Technological add-ons to consent: Pros and cons
Video and computer software are increasingly becoming an integral part of the informed consent process, and may improve comprehension by patients.11 Electronic consent may be helpful in proving what the patient was told during the consent process. A difficulty can result from overreliance on the electronic aspect and forgetting the human part of the informed consent equation. The health care team often can be productive parts of the informed consent process, but the surgeon must take ultimate responsibility for the informed consent.12
Was there informed consent for the tubal ligation?
The major problem in this case, of course, was the tubal ligation. It does not take much of an understanding of the legal niceties of informed consent to know that there was no real consent to this procedure. Dr. Husband did not have authority to consent, and his comment to Dr. Surgeon did not qualify as consent.
The hospital consent form may appear to provide some legal protection (“In his medical judgment, if additional procedures are appropriate, I hereby consent to doing those….”). Such language was once common in informed consent forms, but it offered little real consent except for trivial incidental processes (removal of an appendix) or where there was a real medical necessity for doing an expanded procedure (removal of a previously unknown cancerous growth).
Thus, Dr. Surgeon performed the sterilization without consent and may well be liable for that part of the surgery even though it did not turn out badly in a medical sense. If not for the tubal ligation, the damages would probably have been trivial. The real loss here is not a medical injury; it is the loss of reproductive capacity.
Protecting reproductive capacity. Modern law has been especially sensitive to protecting decisions regarding reproductive capacity. Therefore, the absence of clear consent to permanent sterilization is legally problematic. Dr. Surgeon may claim that he reasonably believed that the husband could give surrogate consent and it was too late to check with the patient herself. This situation does not fit well with the emergency exception, and it appears from the facts that Dr. Surgeon acted without informed consent to the sterilization.
Was it negligence or battery?
Dr. Surgeon. The most likely basis for liability for Dr. Surgeon is negligence. There is some argument that the tort of battery is a possibility because there was no consent at all for the sterilization. The claim would be that it was not the “information” that was lacking; it was the consent itself. The fact that Dr. Surgeon did not charge for his services would not absolve him of liability.
Dr. Husband. The potential liability of Dr. Husband is complicated by questions of whether he was acting in the capacity of a physician (which would likely involve the question of whether his malpractice insurance would be available), the degree to which he was acting in good faith, and facts we do not have in this case. If Dr. Husband gave consent (and thereby “caused”) the sterilization knowing that his wife did not want to have it or because of animus toward her (they were about to be separated and divorced, after all), there is the possibility of liability. (In some states a form of interspousal liability might complicate some of these claims—but that is a topic for another day.) He essentially took action for the purpose of wrongly causing the sterilization—which may be a battery (an intentional offensive or harmful touching). The legal rules around battery allow punitive damages as well as compensatory damages. In addition, many malpractice insurance policies provide limited coverage for intentional torts. To complicate matters further, it is not clear that Dr. Husband’s actions were related to his practice of medicine in any event (although Dr. Surgeon might claim that Dr. Husband’s expressed concern about his wife’s hypertension was enough to create a malpractice issue if Dr. Surgeon did not perform the verbally requested tubal ligation).
If, as we have speculated, Dr. Husband’s actions were motivated by improper personal considerations at the expense of a patient, he may also face medical board complaints from the patient. It is plausible that a state law makes it a criminal offense to wrongfully (or fraudulently) consent to medical treatment, particularly if related to reproductive capacity.
The hospital may face liability on several grounds, depending in part on the relationships between the hospital, Dr. Surgeon, and Dr. Husband. If Dr. Surgeon is an employee or agent of the hospital, he would be liable for his negligence. Even if Dr. Surgeon is technically an independent contractor, the failure of the hospital to offer more oversight concerning the surgical procedures in its facilities could give rise to a claim of negligence.
As to Dr. Husband, many of the same considerations are present. In addition, even if he is an agent of the hospital, the hospital may claim that his actions (especially if motivated by personal considerations) were a “lark of his own” and not in the course of his employment by the hospital.
Read about the clinical opportunity of informed consent
The clinical opportunity of informed consent
More than a technical legal doctrine, informed consent provides ObGyns an important opportunity for better communications with patients, and is a chance to create reasonable expectations and a more therapeutic relationship that involves the patient in care and decision making. It is likely that engaging the patient in good informed consent processes can set the stage for improved outcomes.
Interactive dialogue with the patient is one advised approach.10 This undertaking in part reflects that, as patients have more ready access to information in the digital age, they are positioned to play a more active role in health care decision making.
The benefits of informed consent are likely to be greatest if you view the process not as a technical legal requirement but as an excellent opportunity to engage the patient in her own care and treatment. Planning, intervention, and evaluation of care options as well as education regarding the medical problem at hand are integral to the informed consent process. And, of course, the right to consent is a “basic patient right” that in a sense guarantees that he/she has the right to make informed decisions regarding one’s care.6
Special considerations
Informed consent most often is associated with but not limited to surgical procedures (often performed with the use of surgical instruments and/or devices). It applies to diagnostic interventions as well as treatment. The more invasive or risky an intervention, the more important it is that the information is thorough.14,15
Pharmaceuticals have informed consent issues. The theory has been that pharmaceutical companies inform physicians of the risks and instructions for the use of pharmaceuticals and the physicians inform the patients. Indeed, traditionally pharmaceutical companies have gained immunity for “failure to warn” patients because the physicians were the “learned intermediaries” providing information to the public. Patient package inserts and pharmacists have taken over the informational role, but informed consent does apply to pharmaceuticals.
It is also worth noting that informed consent in any formal research study or the trial of new techniques, compounds, or devices requires a special process of approval by an institutional review board.
Set the stage for best outcomes
The main objective of informed consent is promoting the autonomy of your patient. That requires that she understand the risks, benefits, and alternatives associated with the procedure and the risks associated with a refusal of treatment. Done properly, this can result in your patient gaining confidence and trust in you as her provider.
Informed consent is a process that reflects our interactions with our patients. It is part of the broader commitment by the medical profession to “first do no harm.”
Share your thoughts! Send your Letter to the Editor to rbarbieri@frontlinemedcom.com. Please include your name and the city and state in which you practice.
- Grady C. Enduring and emerging challenges of informed consent. N Engl J Med. 2015;372(22):855–862.
- Faden RR, Beauchamp TL. History and theory of informed consent. New York, New York: Oxford University Press; 1986.
- Paterick TJ, Carson G, Allen M, Paterick TE. Medical informed consent: general considerations for physicians. Mayo Clin Proc. 2008;83(3):313–319.
- American College of Obstetricians and Gynecologists Committee on Ethics. ACOG Committee Opinion No. 439: Informed consent (reaffirmed 2015). Obstet Gynecol. 2009;114(2 pt 1):401–408.
- Jonsen A, Siegler M, Winslade W. Clinical Ethics: A Practical Approach to Ethical Decisions in Clinical Medicine. New York, New York: McGraw Hill; 2010.
- Menendez J. Informed consent: essential legal and ethical principles for nurses. JONAS Healthc Law Ethics Regul. 2013;15(4):140–144.
- Abram MB, Ballantine HT, Dunlop GR, et al; President’s Commission for the Study of Ethical Problems in Medicine and Biomedical and Behavioral Research. Making Health Care Decisions: The Ethical and Legal Implications of Informed Consent in the Patient-Practitioner Relationship. Volume One: Report. https://repository.library.georgetown.edu/bitstream/handle/10822/559354/making_health_care_decisions.pdf?sequence=1. Published October 1982. Accessed January 9, 2017.
- Dhar H, Dhar D. Informed consent in clinical practice and literature overview. Arch Gynecol Obstet. 2012;286(3):649–651.
- NE Schloendorff v Society of New York Hospital, 211 NY 125, 106 NE 93 1914.
- Avery D. Summary of informed consent and refusal. Am J Clinical Med. 2009;6(3):28–29.
- Pallett A, Phippen N, Miller C, Barnett J. Informed consent for hysterectomy: Does a video presentation improve patient comprehension? [poster 17F]. Obstet Gynecol. 2016;127(suppl):55S.
- Cainzos M, Gonzalez-Vinagre S. Informed consent in surgery. World J Surg. 2014;38(7):1587–1593.
- Weaver J. A problem with informed consent. J Am Coll Surg. 2009;209(2):286–287.
- Bunch W. Informed consent. Clin Orthop Relat Res. 2000;378:71–77.
- Peltier LF. Orthopedics: a history and iconography (Norman Orthopedic, No. 3). San Francisco, California: Jeremy Norman Co; 1993.
CASE: Surgeon accused of performing tubal ligation without consent
A patient was scheduled for an elective cesarean delivery to be performed by her ObGyn (Dr. Surgeon) at the nearby medical center. The patient was asked to sign an electronic signature pad in her ObGyn’s office, which transposed her signature onto an electronic form that she could not see at the time. She signed it. The consent was not printed out in the office but was added to her electronic medical record, and a copy was sent to her via email. Among other things, the consent included, “[Name] hereby agrees that all appropriate medical and surgical procedures as determined by the physicians and others in this hospital are in my best interest. No further consent is required to any of the treatment in this hospital.”
In the hospital, Dr. Surgeon spoke preoper- atively with the patient about cesarean delivery, the various risks and benefits, and the possibility and risks of an alternative trial of labor. Dr. Surgeon noted the conversation in the patient’s chart.
A nurse brought a standard hard copy “Zee Hospital Surgical Consent Form” to the patient. In a relevant part it provided, “I hereby consent to the surgical procedure Dr. Surgeon has discussed with me: _______” (the blank was filled in with “cesarean delivery”). The form continued: “He/She has explained the risks and benefits. I also authorize Dr. Surgeon, and such assistants as he/she may select, to perform this procedure. In his/her medical judgment, if additional procedures are appropriate, I hereby consent to their performance, in addition to the procedures listed in this form.” The patient signed the form.
While Dr. Surgeon was scrubbing for the delivery, the patient’s husband (also a surgeon at the hospital; Dr. Husband), stopped by, thanked Dr. Surgeon, and said, “Oh, by the way, my wife would like you to do a tubal ligation as well—she really wants it for health reasons. Her chronic hypertension skyrocketed during this pregnancy, and we don’t want any more children.”
“She didn’t mention that a little earlier while I was talking with her,” replied Dr. Surgeon, “but I can see how it would have slipped her mind.”
Dr. Surgeon performed the cesarean delivery and tubal ligation. All went well, with a healthy baby and mother. Several months later, the patient and Dr. Husband separated and sought divorce.
The patient, surprised by the cost of the hospital bill (Dr. Surgeon did not bill for his surgical services as a professional courtesy), was astonished to see a charge related to tubal ligation. Knowing how common billing mistakes were at Zee Hospital, she called to have the bill corrected. The clerk informed her that her medical record showed that a tubal ligation had been performed and that the bill was correct.
The patient sued Dr. Surgeon, Zee Hospital, and her (now former) husband, Dr. Husband, both for the cesarean delivery and the tubal ligation. Her claims are primarily based on the lack of informed consent.
What’s the verdict?
The patient likely has a strong case regarding the tubal ligation claim, but a weak case related to the cesarean delivery claim.
Read the ethical, medical, and legal implications of this case
Ethical and medical considerations
Although this case seems too strange for fiction, the basic facts are taken from events that did occur at a major institution. The puzzling features of this case are meant to be a cautionary tale: it is easy in the rush with the pressure of clinical practice to view informed consent as a bothersome technical detail. Yet as the following discussion suggests, adhering closely to the tenets of informed consent protects not only the fundamental interests of the patient but also the physicians and medical institutions.
Informed consent serves as protective communication
Informed consent at its core is a “process of communication” that involves you as the health care provider and the patient. It provides authority for an activity based upon an understanding of what that activity entails.1,2 Aspects of informed consent, from the physician−patient perspective, include the following:
- disclosure
- comprehension
- voluntary choice
- authorization.
In one other sense, informed consent is based on a fiduciary relationship between the ObGyn and patient.3 Overall, the process consists of an educational communication by the physician to the patient. Ideally, providers perceive the process from an ethical point of view that has been formalized by cases and statutes.4
Informed consent protects one of the most basic values of medicine and society: autonomy. From the perspective of moral philosophers, the principle of autonomy establishes the moral right to choose and follow one’s own plan for life and action.5,6 For ObGyns, the patient’s autonomy and her ability to participate in the medical decision-making process is of paramount importance. Informed consent is also a reflection of trust inherent to the physician−patient relationship.4
Informed consent is too often viewed as a mere legal formality. In truth, it melds legal and ethical values and concerns. The President’s Commission reflected this, noting that informed consent is rooted in “the fundamental recognition that adults are entitled to accept or reject health care intervention(s) on the basis of their own personal values and in furtherance of their own personal goals.”7
The historic perspective of informed consent dates back to Egyptian, Greek, and Roman eras. Dhar and Dhar suggest that the concept of “physicians’ love for humanity—philantropia” dates back to Plato and is complemented by the term “philotechnia” (love of medicine), all of which have evolved into today’s use of the terms “risks, benefits, and alternatives.”8
We emphasize that informed consent is much more than a legal concept. It has strong clinical roots because it provides an opportunity for physicians to improve communication with their patients. Informed consent is not a form; it is a process to be taken seriously.
Legal principles of informed consent
The famous New York case of Mary Schloendorff v. Society of New York Hospital, in 1914, heralded a principle that remains central in American law. Justice Benjamin Cardozo, writing for the majority, held that, “Every human being of adult years and sound mind has a right to determine what shall be done with his own body; and a surgeon who performs an operation without his patient’s consent commits an assault for which he is liable in damages.”9 The surgeon in the Schloendorff case had undertaken a gynecologic procedure—removal of a fibroid tumor—without patient consent. (In that case the hospital rather than the physician was sued, but the principle clearly applied to the physician.)
Over the last century, the American law of informed consent has developed in a number of ways.10 Lack of informed consent is now almost always considered a form of negligence rather than an intentional tort of battery. The details of the legal requirements vary from state to state as a result of statutory changes and court decisions. But in one way or another, to be “informed,” consent generally must include 4 things:
- a description of the procedure or intervention that is proposed
- the risks and benefits of the proposal—the focus here is generally on the risks of the treatment
- alternatives, if there are any (eg, pharmacologic vs surgical treatment)
- the consequences of not undertaking the proposed treatment (eg, the refusal to have a Papanicolaou smear).
A fifth point might be added—the offer to answer any questions or provide additional information.
These 4 or 5 basic items and the expanded list are efforts to simply describe the information that a reasonable person would need in order to make a decision that represents the patient’s values, personality, and preferences. (Informed consent is in some ways an ongoing process—since a patient may withdraw his/her consent.)
Exceptions to the informed consent requirement
Before turning to the facts in the hypothetical case, it is worth noting that there are 2 common exceptions to the informed consent requirement. The first is an emergency exception. When someone requires immediate attention and the patient is not conscious or capable of consent (nor is a “next of kin” available), treatment may proceed.
The second is therapeutic exception. Its designation is narrow, and it is risky to rely on it except in extreme circumstances. But when the very process of informing the patient of all the risks of a proposed treatment would create significant additional risks for the patient, the consent process may be modified. For example, for an extremely suggestable patient, describing certain risks might, in a psychosomatic way, cause the risk to be realized. In such cases, the record must be clearly documented. It is generally best to discuss the matter with a family member or other surrogate decision maker.
Read what went wrong in this case
What went wrong with consent in this case?
Our case illustrates a number of problems that occur when informed consent is not properly completed.
The electronic signature on the broadly stated consent form the patient initially signed in the office was nearly useless. She did not know what she was signing, did not have any chance to read it before signing, and was provided no help with any of the information factors of informed consent.
The surgical consent form is among the most interesting elements of this case. The form itself was seriously flawed because it contained no real evidence that the patient received information about the risks and alternatives. If the form is all there was, it would be a problem. But the conversation that Dr. Surgeon documented with the patient seemed to provide the basic elements of informed consent, including discussion of risks and benefits.
Oral informed consent is recognized in most states. To his credit, Dr. Surgeon appropriately recorded the conversation in the record. The risk of oral informed consent not backed up by text signature is that, if a dispute arises about the consent, it is difficult to prove details of what was said. (There was, of course, no such dispute about the cesarean delivery as it turned out in this case.)
Technological add-ons to consent: Pros and cons
Video and computer software are increasingly becoming an integral part of the informed consent process, and may improve comprehension by patients.11 Electronic consent may be helpful in proving what the patient was told during the consent process. A difficulty can result from overreliance on the electronic aspect and forgetting the human part of the informed consent equation. The health care team often can be productive parts of the informed consent process, but the surgeon must take ultimate responsibility for the informed consent.12
Was there informed consent for the tubal ligation?
The major problem in this case, of course, was the tubal ligation. It does not take much of an understanding of the legal niceties of informed consent to know that there was no real consent to this procedure. Dr. Husband did not have authority to consent, and his comment to Dr. Surgeon did not qualify as consent.
The hospital consent form may appear to provide some legal protection (“In his medical judgment, if additional procedures are appropriate, I hereby consent to doing those….”). Such language was once common in informed consent forms, but it offered little real consent except for trivial incidental processes (removal of an appendix) or where there was a real medical necessity for doing an expanded procedure (removal of a previously unknown cancerous growth).
Thus, Dr. Surgeon performed the sterilization without consent and may well be liable for that part of the surgery even though it did not turn out badly in a medical sense. If not for the tubal ligation, the damages would probably have been trivial. The real loss here is not a medical injury; it is the loss of reproductive capacity.
Protecting reproductive capacity. Modern law has been especially sensitive to protecting decisions regarding reproductive capacity. Therefore, the absence of clear consent to permanent sterilization is legally problematic. Dr. Surgeon may claim that he reasonably believed that the husband could give surrogate consent and it was too late to check with the patient herself. This situation does not fit well with the emergency exception, and it appears from the facts that Dr. Surgeon acted without informed consent to the sterilization.
Was it negligence or battery?
Dr. Surgeon. The most likely basis for liability for Dr. Surgeon is negligence. There is some argument that the tort of battery is a possibility because there was no consent at all for the sterilization. The claim would be that it was not the “information” that was lacking; it was the consent itself. The fact that Dr. Surgeon did not charge for his services would not absolve him of liability.
Dr. Husband. The potential liability of Dr. Husband is complicated by questions of whether he was acting in the capacity of a physician (which would likely involve the question of whether his malpractice insurance would be available), the degree to which he was acting in good faith, and facts we do not have in this case. If Dr. Husband gave consent (and thereby “caused”) the sterilization knowing that his wife did not want to have it or because of animus toward her (they were about to be separated and divorced, after all), there is the possibility of liability. (In some states a form of interspousal liability might complicate some of these claims—but that is a topic for another day.) He essentially took action for the purpose of wrongly causing the sterilization—which may be a battery (an intentional offensive or harmful touching). The legal rules around battery allow punitive damages as well as compensatory damages. In addition, many malpractice insurance policies provide limited coverage for intentional torts. To complicate matters further, it is not clear that Dr. Husband’s actions were related to his practice of medicine in any event (although Dr. Surgeon might claim that Dr. Husband’s expressed concern about his wife’s hypertension was enough to create a malpractice issue if Dr. Surgeon did not perform the verbally requested tubal ligation).
If, as we have speculated, Dr. Husband’s actions were motivated by improper personal considerations at the expense of a patient, he may also face medical board complaints from the patient. It is plausible that a state law makes it a criminal offense to wrongfully (or fraudulently) consent to medical treatment, particularly if related to reproductive capacity.
The hospital may face liability on several grounds, depending in part on the relationships between the hospital, Dr. Surgeon, and Dr. Husband. If Dr. Surgeon is an employee or agent of the hospital, he would be liable for his negligence. Even if Dr. Surgeon is technically an independent contractor, the failure of the hospital to offer more oversight concerning the surgical procedures in its facilities could give rise to a claim of negligence.
As to Dr. Husband, many of the same considerations are present. In addition, even if he is an agent of the hospital, the hospital may claim that his actions (especially if motivated by personal considerations) were a “lark of his own” and not in the course of his employment by the hospital.
Read about the clinical opportunity of informed consent
The clinical opportunity of informed consent
More than a technical legal doctrine, informed consent provides ObGyns an important opportunity for better communications with patients, and is a chance to create reasonable expectations and a more therapeutic relationship that involves the patient in care and decision making. It is likely that engaging the patient in good informed consent processes can set the stage for improved outcomes.
Interactive dialogue with the patient is one advised approach.10 This undertaking in part reflects that, as patients have more ready access to information in the digital age, they are positioned to play a more active role in health care decision making.
The benefits of informed consent are likely to be greatest if you view the process not as a technical legal requirement but as an excellent opportunity to engage the patient in her own care and treatment. Planning, intervention, and evaluation of care options as well as education regarding the medical problem at hand are integral to the informed consent process. And, of course, the right to consent is a “basic patient right” that in a sense guarantees that he/she has the right to make informed decisions regarding one’s care.6
Special considerations
Informed consent most often is associated with but not limited to surgical procedures (often performed with the use of surgical instruments and/or devices). It applies to diagnostic interventions as well as treatment. The more invasive or risky an intervention, the more important it is that the information is thorough.14,15
Pharmaceuticals have informed consent issues. The theory has been that pharmaceutical companies inform physicians of the risks and instructions for the use of pharmaceuticals and the physicians inform the patients. Indeed, traditionally pharmaceutical companies have gained immunity for “failure to warn” patients because the physicians were the “learned intermediaries” providing information to the public. Patient package inserts and pharmacists have taken over the informational role, but informed consent does apply to pharmaceuticals.
It is also worth noting that informed consent in any formal research study or the trial of new techniques, compounds, or devices requires a special process of approval by an institutional review board.
Set the stage for best outcomes
The main objective of informed consent is promoting the autonomy of your patient. That requires that she understand the risks, benefits, and alternatives associated with the procedure and the risks associated with a refusal of treatment. Done properly, this can result in your patient gaining confidence and trust in you as her provider.
Informed consent is a process that reflects our interactions with our patients. It is part of the broader commitment by the medical profession to “first do no harm.”
Share your thoughts! Send your Letter to the Editor to rbarbieri@frontlinemedcom.com. Please include your name and the city and state in which you practice.
CASE: Surgeon accused of performing tubal ligation without consent
A patient was scheduled for an elective cesarean delivery to be performed by her ObGyn (Dr. Surgeon) at the nearby medical center. The patient was asked to sign an electronic signature pad in her ObGyn’s office, which transposed her signature onto an electronic form that she could not see at the time. She signed it. The consent was not printed out in the office but was added to her electronic medical record, and a copy was sent to her via email. Among other things, the consent included, “[Name] hereby agrees that all appropriate medical and surgical procedures as determined by the physicians and others in this hospital are in my best interest. No further consent is required to any of the treatment in this hospital.”
In the hospital, Dr. Surgeon spoke preoper- atively with the patient about cesarean delivery, the various risks and benefits, and the possibility and risks of an alternative trial of labor. Dr. Surgeon noted the conversation in the patient’s chart.
A nurse brought a standard hard copy “Zee Hospital Surgical Consent Form” to the patient. In a relevant part it provided, “I hereby consent to the surgical procedure Dr. Surgeon has discussed with me: _______” (the blank was filled in with “cesarean delivery”). The form continued: “He/She has explained the risks and benefits. I also authorize Dr. Surgeon, and such assistants as he/she may select, to perform this procedure. In his/her medical judgment, if additional procedures are appropriate, I hereby consent to their performance, in addition to the procedures listed in this form.” The patient signed the form.
While Dr. Surgeon was scrubbing for the delivery, the patient’s husband (also a surgeon at the hospital; Dr. Husband), stopped by, thanked Dr. Surgeon, and said, “Oh, by the way, my wife would like you to do a tubal ligation as well—she really wants it for health reasons. Her chronic hypertension skyrocketed during this pregnancy, and we don’t want any more children.”
“She didn’t mention that a little earlier while I was talking with her,” replied Dr. Surgeon, “but I can see how it would have slipped her mind.”
Dr. Surgeon performed the cesarean delivery and tubal ligation. All went well, with a healthy baby and mother. Several months later, the patient and Dr. Husband separated and sought divorce.
The patient, surprised by the cost of the hospital bill (Dr. Surgeon did not bill for his surgical services as a professional courtesy), was astonished to see a charge related to tubal ligation. Knowing how common billing mistakes were at Zee Hospital, she called to have the bill corrected. The clerk informed her that her medical record showed that a tubal ligation had been performed and that the bill was correct.
The patient sued Dr. Surgeon, Zee Hospital, and her (now former) husband, Dr. Husband, both for the cesarean delivery and the tubal ligation. Her claims are primarily based on the lack of informed consent.
What’s the verdict?
The patient likely has a strong case regarding the tubal ligation claim, but a weak case related to the cesarean delivery claim.
Read the ethical, medical, and legal implications of this case
Ethical and medical considerations
Although this case seems too strange for fiction, the basic facts are taken from events that did occur at a major institution. The puzzling features of this case are meant to be a cautionary tale: it is easy in the rush with the pressure of clinical practice to view informed consent as a bothersome technical detail. Yet as the following discussion suggests, adhering closely to the tenets of informed consent protects not only the fundamental interests of the patient but also the physicians and medical institutions.
Informed consent serves as protective communication
Informed consent at its core is a “process of communication” that involves you as the health care provider and the patient. It provides authority for an activity based upon an understanding of what that activity entails.1,2 Aspects of informed consent, from the physician−patient perspective, include the following:
- disclosure
- comprehension
- voluntary choice
- authorization.
In one other sense, informed consent is based on a fiduciary relationship between the ObGyn and patient.3 Overall, the process consists of an educational communication by the physician to the patient. Ideally, providers perceive the process from an ethical point of view that has been formalized by cases and statutes.4
Informed consent protects one of the most basic values of medicine and society: autonomy. From the perspective of moral philosophers, the principle of autonomy establishes the moral right to choose and follow one’s own plan for life and action.5,6 For ObGyns, the patient’s autonomy and her ability to participate in the medical decision-making process is of paramount importance. Informed consent is also a reflection of trust inherent to the physician−patient relationship.4
Informed consent is too often viewed as a mere legal formality. In truth, it melds legal and ethical values and concerns. The President’s Commission reflected this, noting that informed consent is rooted in “the fundamental recognition that adults are entitled to accept or reject health care intervention(s) on the basis of their own personal values and in furtherance of their own personal goals.”7
The historic perspective of informed consent dates back to Egyptian, Greek, and Roman eras. Dhar and Dhar suggest that the concept of “physicians’ love for humanity—philantropia” dates back to Plato and is complemented by the term “philotechnia” (love of medicine), all of which have evolved into today’s use of the terms “risks, benefits, and alternatives.”8
We emphasize that informed consent is much more than a legal concept. It has strong clinical roots because it provides an opportunity for physicians to improve communication with their patients. Informed consent is not a form; it is a process to be taken seriously.
Legal principles of informed consent
The famous New York case of Mary Schloendorff v. Society of New York Hospital, in 1914, heralded a principle that remains central in American law. Justice Benjamin Cardozo, writing for the majority, held that, “Every human being of adult years and sound mind has a right to determine what shall be done with his own body; and a surgeon who performs an operation without his patient’s consent commits an assault for which he is liable in damages.”9 The surgeon in the Schloendorff case had undertaken a gynecologic procedure—removal of a fibroid tumor—without patient consent. (In that case the hospital rather than the physician was sued, but the principle clearly applied to the physician.)
Over the last century, the American law of informed consent has developed in a number of ways.10 Lack of informed consent is now almost always considered a form of negligence rather than an intentional tort of battery. The details of the legal requirements vary from state to state as a result of statutory changes and court decisions. But in one way or another, to be “informed,” consent generally must include 4 things:
- a description of the procedure or intervention that is proposed
- the risks and benefits of the proposal—the focus here is generally on the risks of the treatment
- alternatives, if there are any (eg, pharmacologic vs surgical treatment)
- the consequences of not undertaking the proposed treatment (eg, the refusal to have a Papanicolaou smear).
A fifth point might be added—the offer to answer any questions or provide additional information.
These 4 or 5 basic items and the expanded list are efforts to simply describe the information that a reasonable person would need in order to make a decision that represents the patient’s values, personality, and preferences. (Informed consent is in some ways an ongoing process—since a patient may withdraw his/her consent.)
Exceptions to the informed consent requirement
Before turning to the facts in the hypothetical case, it is worth noting that there are 2 common exceptions to the informed consent requirement. The first is an emergency exception. When someone requires immediate attention and the patient is not conscious or capable of consent (nor is a “next of kin” available), treatment may proceed.
The second is therapeutic exception. Its designation is narrow, and it is risky to rely on it except in extreme circumstances. But when the very process of informing the patient of all the risks of a proposed treatment would create significant additional risks for the patient, the consent process may be modified. For example, for an extremely suggestable patient, describing certain risks might, in a psychosomatic way, cause the risk to be realized. In such cases, the record must be clearly documented. It is generally best to discuss the matter with a family member or other surrogate decision maker.
Read what went wrong in this case
What went wrong with consent in this case?
Our case illustrates a number of problems that occur when informed consent is not properly completed.
The electronic signature on the broadly stated consent form the patient initially signed in the office was nearly useless. She did not know what she was signing, did not have any chance to read it before signing, and was provided no help with any of the information factors of informed consent.
The surgical consent form is among the most interesting elements of this case. The form itself was seriously flawed because it contained no real evidence that the patient received information about the risks and alternatives. If the form is all there was, it would be a problem. But the conversation that Dr. Surgeon documented with the patient seemed to provide the basic elements of informed consent, including discussion of risks and benefits.
Oral informed consent is recognized in most states. To his credit, Dr. Surgeon appropriately recorded the conversation in the record. The risk of oral informed consent not backed up by text signature is that, if a dispute arises about the consent, it is difficult to prove details of what was said. (There was, of course, no such dispute about the cesarean delivery as it turned out in this case.)
Technological add-ons to consent: Pros and cons
Video and computer software are increasingly becoming an integral part of the informed consent process, and may improve comprehension by patients.11 Electronic consent may be helpful in proving what the patient was told during the consent process. A difficulty can result from overreliance on the electronic aspect and forgetting the human part of the informed consent equation. The health care team often can be productive parts of the informed consent process, but the surgeon must take ultimate responsibility for the informed consent.12
Was there informed consent for the tubal ligation?
The major problem in this case, of course, was the tubal ligation. It does not take much of an understanding of the legal niceties of informed consent to know that there was no real consent to this procedure. Dr. Husband did not have authority to consent, and his comment to Dr. Surgeon did not qualify as consent.
The hospital consent form may appear to provide some legal protection (“In his medical judgment, if additional procedures are appropriate, I hereby consent to doing those….”). Such language was once common in informed consent forms, but it offered little real consent except for trivial incidental processes (removal of an appendix) or where there was a real medical necessity for doing an expanded procedure (removal of a previously unknown cancerous growth).
Thus, Dr. Surgeon performed the sterilization without consent and may well be liable for that part of the surgery even though it did not turn out badly in a medical sense. If not for the tubal ligation, the damages would probably have been trivial. The real loss here is not a medical injury; it is the loss of reproductive capacity.
Protecting reproductive capacity. Modern law has been especially sensitive to protecting decisions regarding reproductive capacity. Therefore, the absence of clear consent to permanent sterilization is legally problematic. Dr. Surgeon may claim that he reasonably believed that the husband could give surrogate consent and it was too late to check with the patient herself. This situation does not fit well with the emergency exception, and it appears from the facts that Dr. Surgeon acted without informed consent to the sterilization.
Was it negligence or battery?
Dr. Surgeon. The most likely basis for liability for Dr. Surgeon is negligence. There is some argument that the tort of battery is a possibility because there was no consent at all for the sterilization. The claim would be that it was not the “information” that was lacking; it was the consent itself. The fact that Dr. Surgeon did not charge for his services would not absolve him of liability.
Dr. Husband. The potential liability of Dr. Husband is complicated by questions of whether he was acting in the capacity of a physician (which would likely involve the question of whether his malpractice insurance would be available), the degree to which he was acting in good faith, and facts we do not have in this case. If Dr. Husband gave consent (and thereby “caused”) the sterilization knowing that his wife did not want to have it or because of animus toward her (they were about to be separated and divorced, after all), there is the possibility of liability. (In some states a form of interspousal liability might complicate some of these claims—but that is a topic for another day.) He essentially took action for the purpose of wrongly causing the sterilization—which may be a battery (an intentional offensive or harmful touching). The legal rules around battery allow punitive damages as well as compensatory damages. In addition, many malpractice insurance policies provide limited coverage for intentional torts. To complicate matters further, it is not clear that Dr. Husband’s actions were related to his practice of medicine in any event (although Dr. Surgeon might claim that Dr. Husband’s expressed concern about his wife’s hypertension was enough to create a malpractice issue if Dr. Surgeon did not perform the verbally requested tubal ligation).
If, as we have speculated, Dr. Husband’s actions were motivated by improper personal considerations at the expense of a patient, he may also face medical board complaints from the patient. It is plausible that a state law makes it a criminal offense to wrongfully (or fraudulently) consent to medical treatment, particularly if related to reproductive capacity.
The hospital may face liability on several grounds, depending in part on the relationships between the hospital, Dr. Surgeon, and Dr. Husband. If Dr. Surgeon is an employee or agent of the hospital, he would be liable for his negligence. Even if Dr. Surgeon is technically an independent contractor, the failure of the hospital to offer more oversight concerning the surgical procedures in its facilities could give rise to a claim of negligence.
As to Dr. Husband, many of the same considerations are present. In addition, even if he is an agent of the hospital, the hospital may claim that his actions (especially if motivated by personal considerations) were a “lark of his own” and not in the course of his employment by the hospital.
Read about the clinical opportunity of informed consent
The clinical opportunity of informed consent
More than a technical legal doctrine, informed consent provides ObGyns an important opportunity for better communications with patients, and is a chance to create reasonable expectations and a more therapeutic relationship that involves the patient in care and decision making. It is likely that engaging the patient in good informed consent processes can set the stage for improved outcomes.
Interactive dialogue with the patient is one advised approach.10 This undertaking in part reflects that, as patients have more ready access to information in the digital age, they are positioned to play a more active role in health care decision making.
The benefits of informed consent are likely to be greatest if you view the process not as a technical legal requirement but as an excellent opportunity to engage the patient in her own care and treatment. Planning, intervention, and evaluation of care options as well as education regarding the medical problem at hand are integral to the informed consent process. And, of course, the right to consent is a “basic patient right” that in a sense guarantees that he/she has the right to make informed decisions regarding one’s care.6
Special considerations
Informed consent most often is associated with but not limited to surgical procedures (often performed with the use of surgical instruments and/or devices). It applies to diagnostic interventions as well as treatment. The more invasive or risky an intervention, the more important it is that the information is thorough.14,15
Pharmaceuticals have informed consent issues. The theory has been that pharmaceutical companies inform physicians of the risks and instructions for the use of pharmaceuticals and the physicians inform the patients. Indeed, traditionally pharmaceutical companies have gained immunity for “failure to warn” patients because the physicians were the “learned intermediaries” providing information to the public. Patient package inserts and pharmacists have taken over the informational role, but informed consent does apply to pharmaceuticals.
It is also worth noting that informed consent in any formal research study or the trial of new techniques, compounds, or devices requires a special process of approval by an institutional review board.
Set the stage for best outcomes
The main objective of informed consent is promoting the autonomy of your patient. That requires that she understand the risks, benefits, and alternatives associated with the procedure and the risks associated with a refusal of treatment. Done properly, this can result in your patient gaining confidence and trust in you as her provider.
Informed consent is a process that reflects our interactions with our patients. It is part of the broader commitment by the medical profession to “first do no harm.”
Share your thoughts! Send your Letter to the Editor to rbarbieri@frontlinemedcom.com. Please include your name and the city and state in which you practice.
- Grady C. Enduring and emerging challenges of informed consent. N Engl J Med. 2015;372(22):855–862.
- Faden RR, Beauchamp TL. History and theory of informed consent. New York, New York: Oxford University Press; 1986.
- Paterick TJ, Carson G, Allen M, Paterick TE. Medical informed consent: general considerations for physicians. Mayo Clin Proc. 2008;83(3):313–319.
- American College of Obstetricians and Gynecologists Committee on Ethics. ACOG Committee Opinion No. 439: Informed consent (reaffirmed 2015). Obstet Gynecol. 2009;114(2 pt 1):401–408.
- Jonsen A, Siegler M, Winslade W. Clinical Ethics: A Practical Approach to Ethical Decisions in Clinical Medicine. New York, New York: McGraw Hill; 2010.
- Menendez J. Informed consent: essential legal and ethical principles for nurses. JONAS Healthc Law Ethics Regul. 2013;15(4):140–144.
- Abram MB, Ballantine HT, Dunlop GR, et al; President’s Commission for the Study of Ethical Problems in Medicine and Biomedical and Behavioral Research. Making Health Care Decisions: The Ethical and Legal Implications of Informed Consent in the Patient-Practitioner Relationship. Volume One: Report. https://repository.library.georgetown.edu/bitstream/handle/10822/559354/making_health_care_decisions.pdf?sequence=1. Published October 1982. Accessed January 9, 2017.
- Dhar H, Dhar D. Informed consent in clinical practice and literature overview. Arch Gynecol Obstet. 2012;286(3):649–651.
- NE Schloendorff v Society of New York Hospital, 211 NY 125, 106 NE 93 1914.
- Avery D. Summary of informed consent and refusal. Am J Clinical Med. 2009;6(3):28–29.
- Pallett A, Phippen N, Miller C, Barnett J. Informed consent for hysterectomy: Does a video presentation improve patient comprehension? [poster 17F]. Obstet Gynecol. 2016;127(suppl):55S.
- Cainzos M, Gonzalez-Vinagre S. Informed consent in surgery. World J Surg. 2014;38(7):1587–1593.
- Weaver J. A problem with informed consent. J Am Coll Surg. 2009;209(2):286–287.
- Bunch W. Informed consent. Clin Orthop Relat Res. 2000;378:71–77.
- Peltier LF. Orthopedics: a history and iconography (Norman Orthopedic, No. 3). San Francisco, California: Jeremy Norman Co; 1993.
- Grady C. Enduring and emerging challenges of informed consent. N Engl J Med. 2015;372(22):855–862.
- Faden RR, Beauchamp TL. History and theory of informed consent. New York, New York: Oxford University Press; 1986.
- Paterick TJ, Carson G, Allen M, Paterick TE. Medical informed consent: general considerations for physicians. Mayo Clin Proc. 2008;83(3):313–319.
- American College of Obstetricians and Gynecologists Committee on Ethics. ACOG Committee Opinion No. 439: Informed consent (reaffirmed 2015). Obstet Gynecol. 2009;114(2 pt 1):401–408.
- Jonsen A, Siegler M, Winslade W. Clinical Ethics: A Practical Approach to Ethical Decisions in Clinical Medicine. New York, New York: McGraw Hill; 2010.
- Menendez J. Informed consent: essential legal and ethical principles for nurses. JONAS Healthc Law Ethics Regul. 2013;15(4):140–144.
- Abram MB, Ballantine HT, Dunlop GR, et al; President’s Commission for the Study of Ethical Problems in Medicine and Biomedical and Behavioral Research. Making Health Care Decisions: The Ethical and Legal Implications of Informed Consent in the Patient-Practitioner Relationship. Volume One: Report. https://repository.library.georgetown.edu/bitstream/handle/10822/559354/making_health_care_decisions.pdf?sequence=1. Published October 1982. Accessed January 9, 2017.
- Dhar H, Dhar D. Informed consent in clinical practice and literature overview. Arch Gynecol Obstet. 2012;286(3):649–651.
- NE Schloendorff v Society of New York Hospital, 211 NY 125, 106 NE 93 1914.
- Avery D. Summary of informed consent and refusal. Am J Clinical Med. 2009;6(3):28–29.
- Pallett A, Phippen N, Miller C, Barnett J. Informed consent for hysterectomy: Does a video presentation improve patient comprehension? [poster 17F]. Obstet Gynecol. 2016;127(suppl):55S.
- Cainzos M, Gonzalez-Vinagre S. Informed consent in surgery. World J Surg. 2014;38(7):1587–1593.
- Weaver J. A problem with informed consent. J Am Coll Surg. 2009;209(2):286–287.
- Bunch W. Informed consent. Clin Orthop Relat Res. 2000;378:71–77.
- Peltier LF. Orthopedics: a history and iconography (Norman Orthopedic, No. 3). San Francisco, California: Jeremy Norman Co; 1993.
Should coffee consumption be added as an adjunct to the postoperative care of gynecologic oncology patients?
EXPERT COMMENTARY
Postoperative ileus is a common complication following abdominal surgery, particularly for patients undergoing laparotomy. Ileus is frustrating for patients and providers alike, and its occurrence may prolong the length of hospital stay, increase the cost of care, worsen patient satisfaction, and potentially delay postoperative treatments, such as chemotherapy for patients with gynecologic malignancies. The etiology of ileus is multifactorial, but it is thought to be caused primarily by a local inflammatory response from mechanical handling and irritation of the bowel. Although various interventions, such as laxatives, peripheral mu antagonists, and chewing gum, have been shown to reduce the occurrence of ileus, the effectiveness of these interventions varies, and ileus remains a major source of morbidity.1
Details of the study
To investigate whether coffee consumption accelerates recovery of bowel function following surgery, Güngördük and colleagues conducted a randomized controlled trial of coffee consumption after laparotomy with hysterectomy and staging for patients with gynecologic malignancies. This intervention avoids costs associated with drugs such as oral mu antagonists.
The trial included 114 women; after surgery, 58 were assigned to consume coffee 3 times daily and 56 received routine postoperative care without coffee consumption. The primary outcome measure was the time to the first passage of flatus after surgery. Time to first bowel movement and time to tolerance of a solid diet were secondary outcomes.
The results of this trial are consistent with prior study findings in colorectal surgery.2 Güngördük and associates found that patients in the coffee-consumption group, compared with controls, had reduced the time to flatus by 12 hours (mean [SD] time to flatus, 30.2 [8.0] vs 40.2 [12.1] hours; P<.001), shortened time to full diet by 1.3 days (mean [SD] time to tolerate food, 3.4 [1.2] vs 4.7 [1.6] days; P<.001), reduced time to first bowel movement by 12 hours (43.1 [9.4] vs 58.5 [17.0] hours; P<.001), and shortened length of hospital stay by 1 day. Symptoms of ileus were reduced from 52% to 14% with coffee consumption.
Study limitation. An important weakness of this study is that although the authors defined the severity of ileus by time to resolution, they did not define what constituted a diagnosis of ileus in the first place.
Unanswered questions. Coffee is a known diarrhetic, so it is not unexpected that its use shortened time to flatus and first bowel movement. What is not known, however, is whether coffee consumption improves recovery. The significance of a 1-day reduction in hospital stay is unclear given the relatively prolonged hospitalization (6 to 7 days) seen in this investigation of patients with mixed gynecologic malignancies who underwent staging only. In contrast, another study showed that, for patients managed within an enhanced recovery pathway (a multimodal perioperative care enhancement protocol), median length of stay was 4 days for patients who underwent staging alone and 5 days for patients with ovarian cancer (40% underwent enteric resections).3 Thus, the effects of coffee consumption are unclear for patients managed with an optimized perioperative pathway.
The improvement in oral intake is also of questionable significance since these patients tolerated a solid diet 3 to 4 days after surgery, compared with the evening of surgery for most patients managed with enhanced recovery.
Incisional injection of liposomal bupivacaine has been associated with a reduction in the rate of ileus from 22% to 11% after complex cytoreduction for ovarian cancer when added to an existing enhanced recovery pathway; rates were only 5% for patients undergoing staging alone.4 These findings may be due to the significant reduction in opioid use that accompanied the use of liposomal bupivacaine.
--SEAN C. DOWDY, MD
Share your thoughts! Send your Letter to the Editor to rbarbieri@frontlinemedcom.com. Please include your name and the city and state in which you practice.
- Nelson G, Altman AD, Nick A, et al. Guidelines for post- operative care in gynecologic/oncology surgery: Enhanced Recovery After Surgery (ERAS) Society recommendations--part II. Gynecol Oncol. 2016;140(2):323-332.
- Müller SA, Rahbari NN, Schneider F, et al. Randomized clinical trial on the effect of coffee on postoperative ileus following elective colectomy. Br J Surg. 2012;99(11):1530-1538.
- Kalogera E, Bakkum-Gamez JN, Jankowski CJ, et al. Enhanced recovery in gynecologic surgery. Obstet Gynecol. 2013;122 (2 pt 1):319-328.
- Kalogera E, Bakkum-Gamez JN, Weaver AL, et al. Abdominal incision injection of liposomal bupivacaine and opioid use after laparotomy for gynecologic malignancies. Obstet Gynecol. 2016;128(5):1009-1017.
EXPERT COMMENTARY
Postoperative ileus is a common complication following abdominal surgery, particularly for patients undergoing laparotomy. Ileus is frustrating for patients and providers alike, and its occurrence may prolong the length of hospital stay, increase the cost of care, worsen patient satisfaction, and potentially delay postoperative treatments, such as chemotherapy for patients with gynecologic malignancies. The etiology of ileus is multifactorial, but it is thought to be caused primarily by a local inflammatory response from mechanical handling and irritation of the bowel. Although various interventions, such as laxatives, peripheral mu antagonists, and chewing gum, have been shown to reduce the occurrence of ileus, the effectiveness of these interventions varies, and ileus remains a major source of morbidity.1
Details of the study
To investigate whether coffee consumption accelerates recovery of bowel function following surgery, Güngördük and colleagues conducted a randomized controlled trial of coffee consumption after laparotomy with hysterectomy and staging for patients with gynecologic malignancies. This intervention avoids costs associated with drugs such as oral mu antagonists.
The trial included 114 women; after surgery, 58 were assigned to consume coffee 3 times daily and 56 received routine postoperative care without coffee consumption. The primary outcome measure was the time to the first passage of flatus after surgery. Time to first bowel movement and time to tolerance of a solid diet were secondary outcomes.
The results of this trial are consistent with prior study findings in colorectal surgery.2 Güngördük and associates found that patients in the coffee-consumption group, compared with controls, had reduced the time to flatus by 12 hours (mean [SD] time to flatus, 30.2 [8.0] vs 40.2 [12.1] hours; P<.001), shortened time to full diet by 1.3 days (mean [SD] time to tolerate food, 3.4 [1.2] vs 4.7 [1.6] days; P<.001), reduced time to first bowel movement by 12 hours (43.1 [9.4] vs 58.5 [17.0] hours; P<.001), and shortened length of hospital stay by 1 day. Symptoms of ileus were reduced from 52% to 14% with coffee consumption.
Study limitation. An important weakness of this study is that although the authors defined the severity of ileus by time to resolution, they did not define what constituted a diagnosis of ileus in the first place.
Unanswered questions. Coffee is a known diarrhetic, so it is not unexpected that its use shortened time to flatus and first bowel movement. What is not known, however, is whether coffee consumption improves recovery. The significance of a 1-day reduction in hospital stay is unclear given the relatively prolonged hospitalization (6 to 7 days) seen in this investigation of patients with mixed gynecologic malignancies who underwent staging only. In contrast, another study showed that, for patients managed within an enhanced recovery pathway (a multimodal perioperative care enhancement protocol), median length of stay was 4 days for patients who underwent staging alone and 5 days for patients with ovarian cancer (40% underwent enteric resections).3 Thus, the effects of coffee consumption are unclear for patients managed with an optimized perioperative pathway.
The improvement in oral intake is also of questionable significance since these patients tolerated a solid diet 3 to 4 days after surgery, compared with the evening of surgery for most patients managed with enhanced recovery.
Incisional injection of liposomal bupivacaine has been associated with a reduction in the rate of ileus from 22% to 11% after complex cytoreduction for ovarian cancer when added to an existing enhanced recovery pathway; rates were only 5% for patients undergoing staging alone.4 These findings may be due to the significant reduction in opioid use that accompanied the use of liposomal bupivacaine.
--SEAN C. DOWDY, MD
Share your thoughts! Send your Letter to the Editor to rbarbieri@frontlinemedcom.com. Please include your name and the city and state in which you practice.
EXPERT COMMENTARY
Postoperative ileus is a common complication following abdominal surgery, particularly for patients undergoing laparotomy. Ileus is frustrating for patients and providers alike, and its occurrence may prolong the length of hospital stay, increase the cost of care, worsen patient satisfaction, and potentially delay postoperative treatments, such as chemotherapy for patients with gynecologic malignancies. The etiology of ileus is multifactorial, but it is thought to be caused primarily by a local inflammatory response from mechanical handling and irritation of the bowel. Although various interventions, such as laxatives, peripheral mu antagonists, and chewing gum, have been shown to reduce the occurrence of ileus, the effectiveness of these interventions varies, and ileus remains a major source of morbidity.1
Details of the study
To investigate whether coffee consumption accelerates recovery of bowel function following surgery, Güngördük and colleagues conducted a randomized controlled trial of coffee consumption after laparotomy with hysterectomy and staging for patients with gynecologic malignancies. This intervention avoids costs associated with drugs such as oral mu antagonists.
The trial included 114 women; after surgery, 58 were assigned to consume coffee 3 times daily and 56 received routine postoperative care without coffee consumption. The primary outcome measure was the time to the first passage of flatus after surgery. Time to first bowel movement and time to tolerance of a solid diet were secondary outcomes.
The results of this trial are consistent with prior study findings in colorectal surgery.2 Güngördük and associates found that patients in the coffee-consumption group, compared with controls, had reduced the time to flatus by 12 hours (mean [SD] time to flatus, 30.2 [8.0] vs 40.2 [12.1] hours; P<.001), shortened time to full diet by 1.3 days (mean [SD] time to tolerate food, 3.4 [1.2] vs 4.7 [1.6] days; P<.001), reduced time to first bowel movement by 12 hours (43.1 [9.4] vs 58.5 [17.0] hours; P<.001), and shortened length of hospital stay by 1 day. Symptoms of ileus were reduced from 52% to 14% with coffee consumption.
Study limitation. An important weakness of this study is that although the authors defined the severity of ileus by time to resolution, they did not define what constituted a diagnosis of ileus in the first place.
Unanswered questions. Coffee is a known diarrhetic, so it is not unexpected that its use shortened time to flatus and first bowel movement. What is not known, however, is whether coffee consumption improves recovery. The significance of a 1-day reduction in hospital stay is unclear given the relatively prolonged hospitalization (6 to 7 days) seen in this investigation of patients with mixed gynecologic malignancies who underwent staging only. In contrast, another study showed that, for patients managed within an enhanced recovery pathway (a multimodal perioperative care enhancement protocol), median length of stay was 4 days for patients who underwent staging alone and 5 days for patients with ovarian cancer (40% underwent enteric resections).3 Thus, the effects of coffee consumption are unclear for patients managed with an optimized perioperative pathway.
The improvement in oral intake is also of questionable significance since these patients tolerated a solid diet 3 to 4 days after surgery, compared with the evening of surgery for most patients managed with enhanced recovery.
Incisional injection of liposomal bupivacaine has been associated with a reduction in the rate of ileus from 22% to 11% after complex cytoreduction for ovarian cancer when added to an existing enhanced recovery pathway; rates were only 5% for patients undergoing staging alone.4 These findings may be due to the significant reduction in opioid use that accompanied the use of liposomal bupivacaine.
--SEAN C. DOWDY, MD
Share your thoughts! Send your Letter to the Editor to rbarbieri@frontlinemedcom.com. Please include your name and the city and state in which you practice.
- Nelson G, Altman AD, Nick A, et al. Guidelines for post- operative care in gynecologic/oncology surgery: Enhanced Recovery After Surgery (ERAS) Society recommendations--part II. Gynecol Oncol. 2016;140(2):323-332.
- Müller SA, Rahbari NN, Schneider F, et al. Randomized clinical trial on the effect of coffee on postoperative ileus following elective colectomy. Br J Surg. 2012;99(11):1530-1538.
- Kalogera E, Bakkum-Gamez JN, Jankowski CJ, et al. Enhanced recovery in gynecologic surgery. Obstet Gynecol. 2013;122 (2 pt 1):319-328.
- Kalogera E, Bakkum-Gamez JN, Weaver AL, et al. Abdominal incision injection of liposomal bupivacaine and opioid use after laparotomy for gynecologic malignancies. Obstet Gynecol. 2016;128(5):1009-1017.
- Nelson G, Altman AD, Nick A, et al. Guidelines for post- operative care in gynecologic/oncology surgery: Enhanced Recovery After Surgery (ERAS) Society recommendations--part II. Gynecol Oncol. 2016;140(2):323-332.
- Müller SA, Rahbari NN, Schneider F, et al. Randomized clinical trial on the effect of coffee on postoperative ileus following elective colectomy. Br J Surg. 2012;99(11):1530-1538.
- Kalogera E, Bakkum-Gamez JN, Jankowski CJ, et al. Enhanced recovery in gynecologic surgery. Obstet Gynecol. 2013;122 (2 pt 1):319-328.
- Kalogera E, Bakkum-Gamez JN, Weaver AL, et al. Abdominal incision injection of liposomal bupivacaine and opioid use after laparotomy for gynecologic malignancies. Obstet Gynecol. 2016;128(5):1009-1017.
Women’s Preventive Services Initiative Guidelines provide consensus for practicing ObGyns
The Patient Protection and Affordable Care Act of 2010 (ACA) intended that women have access to critical preventive health services without a copay or deductible. The Institute of Medicine (IOM) was asked to help identify those critical preventive women’s health services. In 2011, the IOM Committee on Preventive Services for Women recommended that all women have access to 9 preventive services, among them1:
- screening for gestational diabetes mellitus (GDM)
- human papilloma virus testing
- contraceptive methods and counseling
- well-woman visits.
The Health Resources and Services Administration (HRSA) of the US Department of Health and Human Services agreed to update the recommended preventive services every 5 years.
In March 2016, HRSA entered into a 5-year cooperative agreement with the American College of Obstetricians and Gynecologists (ACOG) to update the guidelines and to develop additional recommendations to enhance women’s health.2 ACOG launched the Women’s Preventive Services Initiative (WPSI) to develop the 2016 update.
The 5-year grant with HRSA will address many more preventive health services for women across their lifespan as well as implementation strategies so that women receive consistent and appropriate care, regardless of the health care provider’s specialty. The WPSI recognizes that the selection of a provider for well-woman care will be determined as much by a woman’s needs and preferences as by her access to health care services and health plan availability.
The WPSI draft recommendations were released for public comment in September 2016,2 and HRSA approved the recommendations in December 2016.3 In this editorial, I provide a look at which organizations comprise the WPSI and a summary of the 9 recommended preventive health services.
Who makes up the Women’s Preventive Services Initiative?
The WPSI is a collaboration between professional societies and consumer organizations. The goal of the WPSI is “to promote health over the course of a woman’s lifetime through disease prevention and preventive healthcare.” The WPSI advisory panel provides oversight to the effort and the multidisciplinary steering committee develops the recommendations. The WPSI advisory panel includes leaders and experts from 4 major professional organizations, whose members provide the majority of women’s health care in the United States:
- ACOG
- American College of Physicians (ACP)
- American Academy of Family Physicians (AAFP)
- National Association of Nurse Practitioners in Women’s Health (NPWH).
The multidisciplinary steering committee includes the members of the advisory panel, representatives from 17 professional and consumer organizations, a patient representative, and representatives from 6 federal agencies. The WPSI is currently chaired by Jeanne Conry, MD, PhD, past president of ACOG. The steering committee used evidence-based best practices to develop the guidelines and relied heavily on the foundation provided by the 2011 IOM report.1
The 9 WPSI recommendations
Much of the text below is directly quoted from the final recommendations. When a recommendation is paraphrased it is not placed in quotations.
Recommendation 1: Breast cancer screening for average-risk women
“Average-risk women should initiate mammography screening for breast cancer no earlier than age 40 and no later than age 50 years. Screeningmammography should occur at least biennially and as frequently as annually. Screening should continue through at least age 74 years and age alone should not be the basis to stop screening.”
Decisions about when to initiate screening for women between 40 and 50 years of age, how often to screen, and when to stop screening should be based on shared decision making involving the woman and her clinician.
Recommendation 2: Breastfeeding services and supplies
Women should be provided “comprehensive lactation support services including counseling, education and breast feeding equipment and supplies during the antenatal, perinatal, and postpartum periods.” These services will support the successful initiation and maintenance of breastfeeding. Women should have access to double electric breast pumps.
Recommendation 3: Screening for cervical cancer
Average-risk women should initiate cervical cancer screening with cervical cytology at age 21 years and have cervical cytology testing every 3 years from 21 to 29 years of age. “Cotesting with cytology and human papillomavirus (HPV) testing is not recommended for women younger than 30 years. Women aged 30 to 65 years should be screened with cytology and HPV testing every 5 years or cytology alone every 3 years.” Women who have received the HPV vaccine should be screened using these guidelines. Cervical cancer screening is not recommended for women younger than 21 years or older than 65 years who have had adequate prior screening and are not at high risk for cervical cancer. Cervical cancer screening is also not recommended for women who have had a hysterectomy with removal of the cervix and no personal history of cervical intraepithelial neoplasia grade 2 or 3 within the past 20 years.
Recommendation 4: Contraception
Adolescent and adult women should have access to the full range of US Food and Drug Administration–approved female-controlled contraceptives to prevent unintended pregnancy and improve birth outcomes. Multiple visits with a clinician may be needed to select an optimal contraceptive.
Recommendation 5: Screening for gestational diabetes mellitus
Pregnant women should be screened for GDM between 24 and 28 weeks’ gestation to prevent adverse birth outcomes. Screening should be performed with a “50 gm oral glucose challenge test followed by a 3-hour 100 gm oral glucose tolerance test” if the results on the initial oral glucose tolerance test are abnormal. This testing sequence has high sensitivity and specificity. Women with risk factors for diabetes mellitus should be screened for diabetes at the first prenatal visit using current best clinical practice.
Recommendation 6: Screening for human immunodeficiency virus (HIV) infection
Adolescents and women should receive education and risk assessment for HIV annually and should be tested for HIV at least once during their lifetime. Based on assessed risk, screening annually may be appropriate. “Screening for HIV is recommended for all pregnant women upon initiation of prenatal care with retesting during pregnancy based on risk factors. Rapid HIV testing is recommended for pregnant women who present in active labor with an undocumented HIV status.” Risk-based screening does not identify approximately 20% of HIV-infected people. Hence screening annually may be reasonable.
Recommendation 7: Screening for interpersonal and domestic violence
All adolescents and women should be screened annually for both interpersonal violence (IPV) and domestic violence (DV). Intervention services should be available to all adolescents and women. IPV and DV are prevalent problems, and they are often undetected by clinicians. Hence annual screening is recommended.
Recommendation 8: Counseling for sexually transmitted infections
Adolescents and women should be assessed for sexually transmittedinfection (STI) risk. Risk factors include:
- “age younger than 25 years,
- a recent STI,
- a new sex partner,
- multiple partners,
- a partner with concurrent partners,
- a partner with an STI, and
- a lack of or inconsistent condom use.”
Women at increased risk for an STI should receive behavioral counseling.
Recommendation 9: Well-woman preventive visits
Women should “receive at least one preventive care visit per year beginning in adolescence and continuing across the lifespan to ensure that the recommended preventive services including preconception and many services necessary for prenatal and interconception care are obtained. The primary purpose of these visits is the delivery and coordination of recommended preventive services as determined by age and risk factors.”
- Abridged guidelines for the Women's Preventive Services Initiative can be found here: http://www.womenspreventivehealth.org/wp-content/uploads/2017/01/WPSI_2016AbridgedReport.pdf.
- Evidence-based summaries and appendices are available at this link: http://www.womenspreventivehealth.org/wp-content/uploads/2016/12/Evidence-Summaries-and-Appendices.pdf.
I plan on using these recommendations to guide my practice
Historically, many high-profile expert professional groups have developed their own women’s health services guidelines. The proliferation of conflicting guidelines confused both patients and clinicians. Dueling guidelines likely undermine public health because they result in confusion among patients and inconsistent care across the many disciplines that provide medical services to women.
The proliferation of conflicting guidelines for mammography screening for breast cancer is a good example of how dueling guidelines can undermine public health (TABLE).4−7 The WPSI has done a great service to women and clinicians by creating a shared framework for consistently providing critical services across a woman’s entire life. I plan on using these recommendations to guide my practice. Patients and clinicians will greatly benefit from the exceptionally thoughtful women’s preventive services guidelines provided by the WPSI.
Share your thoughts! Send your Letter to the Editor to rbarbieri@frontlinemedcom.com. Please include your name and the city and state in which you practice.
- Institute of Medicine. Clinical preventive services for women: closing the gaps. Washington DC: The National Academies Press; 2011. http://nap.edu/13181. Accessed January 16, 2017.
- American Congress of Obstetricians and Gynecologists (ACOG). Women's Preventive Services Initiative (WPSI). http://www.acog.org/About-ACOG/ACOG-Departments/Annual-Womens-Health-Care/Womens-Preventive-Services-Initiative. Accessed January 16, 2017.
- Health Resources and Services Administration website. Women's preventive services guidelines. https://www.hrsa.gov/womensguidelines/. Accessed January 16, 2017.
- American College of Obstetricians and Gynecologists. Practice bulletin no. 122: breast cancer screening. Obstet Gynecol. 2011;118(2 pt 1):372-382.
- Oeffinger KC, Fontham ET, Etzioni R, et al. Breast cancer screening for women at average risk: 2015 guideline update from the American Cancer Society. JAMA. 2015;314(15):1599-1614.
- American Academy of Family Physicians website. Clinical preventive service recommendation: breast cancer. http://www.aafp.org/patient-care/clinical-recommendations/all/breast-cancer.html. Accessed January 16, 2017.
- US Preventive Services Task Force. Screening for breast cancer: U.S. Preventive Services Task Force recommendation statement. Ann Intern Med. 2009;151(10):716-726.
The Patient Protection and Affordable Care Act of 2010 (ACA) intended that women have access to critical preventive health services without a copay or deductible. The Institute of Medicine (IOM) was asked to help identify those critical preventive women’s health services. In 2011, the IOM Committee on Preventive Services for Women recommended that all women have access to 9 preventive services, among them1:
- screening for gestational diabetes mellitus (GDM)
- human papilloma virus testing
- contraceptive methods and counseling
- well-woman visits.
The Health Resources and Services Administration (HRSA) of the US Department of Health and Human Services agreed to update the recommended preventive services every 5 years.
In March 2016, HRSA entered into a 5-year cooperative agreement with the American College of Obstetricians and Gynecologists (ACOG) to update the guidelines and to develop additional recommendations to enhance women’s health.2 ACOG launched the Women’s Preventive Services Initiative (WPSI) to develop the 2016 update.
The 5-year grant with HRSA will address many more preventive health services for women across their lifespan as well as implementation strategies so that women receive consistent and appropriate care, regardless of the health care provider’s specialty. The WPSI recognizes that the selection of a provider for well-woman care will be determined as much by a woman’s needs and preferences as by her access to health care services and health plan availability.
The WPSI draft recommendations were released for public comment in September 2016,2 and HRSA approved the recommendations in December 2016.3 In this editorial, I provide a look at which organizations comprise the WPSI and a summary of the 9 recommended preventive health services.
Who makes up the Women’s Preventive Services Initiative?
The WPSI is a collaboration between professional societies and consumer organizations. The goal of the WPSI is “to promote health over the course of a woman’s lifetime through disease prevention and preventive healthcare.” The WPSI advisory panel provides oversight to the effort and the multidisciplinary steering committee develops the recommendations. The WPSI advisory panel includes leaders and experts from 4 major professional organizations, whose members provide the majority of women’s health care in the United States:
- ACOG
- American College of Physicians (ACP)
- American Academy of Family Physicians (AAFP)
- National Association of Nurse Practitioners in Women’s Health (NPWH).
The multidisciplinary steering committee includes the members of the advisory panel, representatives from 17 professional and consumer organizations, a patient representative, and representatives from 6 federal agencies. The WPSI is currently chaired by Jeanne Conry, MD, PhD, past president of ACOG. The steering committee used evidence-based best practices to develop the guidelines and relied heavily on the foundation provided by the 2011 IOM report.1
The 9 WPSI recommendations
Much of the text below is directly quoted from the final recommendations. When a recommendation is paraphrased it is not placed in quotations.
Recommendation 1: Breast cancer screening for average-risk women
“Average-risk women should initiate mammography screening for breast cancer no earlier than age 40 and no later than age 50 years. Screeningmammography should occur at least biennially and as frequently as annually. Screening should continue through at least age 74 years and age alone should not be the basis to stop screening.”
Decisions about when to initiate screening for women between 40 and 50 years of age, how often to screen, and when to stop screening should be based on shared decision making involving the woman and her clinician.
Recommendation 2: Breastfeeding services and supplies
Women should be provided “comprehensive lactation support services including counseling, education and breast feeding equipment and supplies during the antenatal, perinatal, and postpartum periods.” These services will support the successful initiation and maintenance of breastfeeding. Women should have access to double electric breast pumps.
Recommendation 3: Screening for cervical cancer
Average-risk women should initiate cervical cancer screening with cervical cytology at age 21 years and have cervical cytology testing every 3 years from 21 to 29 years of age. “Cotesting with cytology and human papillomavirus (HPV) testing is not recommended for women younger than 30 years. Women aged 30 to 65 years should be screened with cytology and HPV testing every 5 years or cytology alone every 3 years.” Women who have received the HPV vaccine should be screened using these guidelines. Cervical cancer screening is not recommended for women younger than 21 years or older than 65 years who have had adequate prior screening and are not at high risk for cervical cancer. Cervical cancer screening is also not recommended for women who have had a hysterectomy with removal of the cervix and no personal history of cervical intraepithelial neoplasia grade 2 or 3 within the past 20 years.
Recommendation 4: Contraception
Adolescent and adult women should have access to the full range of US Food and Drug Administration–approved female-controlled contraceptives to prevent unintended pregnancy and improve birth outcomes. Multiple visits with a clinician may be needed to select an optimal contraceptive.
Recommendation 5: Screening for gestational diabetes mellitus
Pregnant women should be screened for GDM between 24 and 28 weeks’ gestation to prevent adverse birth outcomes. Screening should be performed with a “50 gm oral glucose challenge test followed by a 3-hour 100 gm oral glucose tolerance test” if the results on the initial oral glucose tolerance test are abnormal. This testing sequence has high sensitivity and specificity. Women with risk factors for diabetes mellitus should be screened for diabetes at the first prenatal visit using current best clinical practice.
Recommendation 6: Screening for human immunodeficiency virus (HIV) infection
Adolescents and women should receive education and risk assessment for HIV annually and should be tested for HIV at least once during their lifetime. Based on assessed risk, screening annually may be appropriate. “Screening for HIV is recommended for all pregnant women upon initiation of prenatal care with retesting during pregnancy based on risk factors. Rapid HIV testing is recommended for pregnant women who present in active labor with an undocumented HIV status.” Risk-based screening does not identify approximately 20% of HIV-infected people. Hence screening annually may be reasonable.
Recommendation 7: Screening for interpersonal and domestic violence
All adolescents and women should be screened annually for both interpersonal violence (IPV) and domestic violence (DV). Intervention services should be available to all adolescents and women. IPV and DV are prevalent problems, and they are often undetected by clinicians. Hence annual screening is recommended.
Recommendation 8: Counseling for sexually transmitted infections
Adolescents and women should be assessed for sexually transmittedinfection (STI) risk. Risk factors include:
- “age younger than 25 years,
- a recent STI,
- a new sex partner,
- multiple partners,
- a partner with concurrent partners,
- a partner with an STI, and
- a lack of or inconsistent condom use.”
Women at increased risk for an STI should receive behavioral counseling.
Recommendation 9: Well-woman preventive visits
Women should “receive at least one preventive care visit per year beginning in adolescence and continuing across the lifespan to ensure that the recommended preventive services including preconception and many services necessary for prenatal and interconception care are obtained. The primary purpose of these visits is the delivery and coordination of recommended preventive services as determined by age and risk factors.”
- Abridged guidelines for the Women's Preventive Services Initiative can be found here: http://www.womenspreventivehealth.org/wp-content/uploads/2017/01/WPSI_2016AbridgedReport.pdf.
- Evidence-based summaries and appendices are available at this link: http://www.womenspreventivehealth.org/wp-content/uploads/2016/12/Evidence-Summaries-and-Appendices.pdf.
I plan on using these recommendations to guide my practice
Historically, many high-profile expert professional groups have developed their own women’s health services guidelines. The proliferation of conflicting guidelines confused both patients and clinicians. Dueling guidelines likely undermine public health because they result in confusion among patients and inconsistent care across the many disciplines that provide medical services to women.
The proliferation of conflicting guidelines for mammography screening for breast cancer is a good example of how dueling guidelines can undermine public health (TABLE).4−7 The WPSI has done a great service to women and clinicians by creating a shared framework for consistently providing critical services across a woman’s entire life. I plan on using these recommendations to guide my practice. Patients and clinicians will greatly benefit from the exceptionally thoughtful women’s preventive services guidelines provided by the WPSI.
Share your thoughts! Send your Letter to the Editor to rbarbieri@frontlinemedcom.com. Please include your name and the city and state in which you practice.
The Patient Protection and Affordable Care Act of 2010 (ACA) intended that women have access to critical preventive health services without a copay or deductible. The Institute of Medicine (IOM) was asked to help identify those critical preventive women’s health services. In 2011, the IOM Committee on Preventive Services for Women recommended that all women have access to 9 preventive services, among them1:
- screening for gestational diabetes mellitus (GDM)
- human papilloma virus testing
- contraceptive methods and counseling
- well-woman visits.
The Health Resources and Services Administration (HRSA) of the US Department of Health and Human Services agreed to update the recommended preventive services every 5 years.
In March 2016, HRSA entered into a 5-year cooperative agreement with the American College of Obstetricians and Gynecologists (ACOG) to update the guidelines and to develop additional recommendations to enhance women’s health.2 ACOG launched the Women’s Preventive Services Initiative (WPSI) to develop the 2016 update.
The 5-year grant with HRSA will address many more preventive health services for women across their lifespan as well as implementation strategies so that women receive consistent and appropriate care, regardless of the health care provider’s specialty. The WPSI recognizes that the selection of a provider for well-woman care will be determined as much by a woman’s needs and preferences as by her access to health care services and health plan availability.
The WPSI draft recommendations were released for public comment in September 2016,2 and HRSA approved the recommendations in December 2016.3 In this editorial, I provide a look at which organizations comprise the WPSI and a summary of the 9 recommended preventive health services.
Who makes up the Women’s Preventive Services Initiative?
The WPSI is a collaboration between professional societies and consumer organizations. The goal of the WPSI is “to promote health over the course of a woman’s lifetime through disease prevention and preventive healthcare.” The WPSI advisory panel provides oversight to the effort and the multidisciplinary steering committee develops the recommendations. The WPSI advisory panel includes leaders and experts from 4 major professional organizations, whose members provide the majority of women’s health care in the United States:
- ACOG
- American College of Physicians (ACP)
- American Academy of Family Physicians (AAFP)
- National Association of Nurse Practitioners in Women’s Health (NPWH).
The multidisciplinary steering committee includes the members of the advisory panel, representatives from 17 professional and consumer organizations, a patient representative, and representatives from 6 federal agencies. The WPSI is currently chaired by Jeanne Conry, MD, PhD, past president of ACOG. The steering committee used evidence-based best practices to develop the guidelines and relied heavily on the foundation provided by the 2011 IOM report.1
The 9 WPSI recommendations
Much of the text below is directly quoted from the final recommendations. When a recommendation is paraphrased it is not placed in quotations.
Recommendation 1: Breast cancer screening for average-risk women
“Average-risk women should initiate mammography screening for breast cancer no earlier than age 40 and no later than age 50 years. Screeningmammography should occur at least biennially and as frequently as annually. Screening should continue through at least age 74 years and age alone should not be the basis to stop screening.”
Decisions about when to initiate screening for women between 40 and 50 years of age, how often to screen, and when to stop screening should be based on shared decision making involving the woman and her clinician.
Recommendation 2: Breastfeeding services and supplies
Women should be provided “comprehensive lactation support services including counseling, education and breast feeding equipment and supplies during the antenatal, perinatal, and postpartum periods.” These services will support the successful initiation and maintenance of breastfeeding. Women should have access to double electric breast pumps.
Recommendation 3: Screening for cervical cancer
Average-risk women should initiate cervical cancer screening with cervical cytology at age 21 years and have cervical cytology testing every 3 years from 21 to 29 years of age. “Cotesting with cytology and human papillomavirus (HPV) testing is not recommended for women younger than 30 years. Women aged 30 to 65 years should be screened with cytology and HPV testing every 5 years or cytology alone every 3 years.” Women who have received the HPV vaccine should be screened using these guidelines. Cervical cancer screening is not recommended for women younger than 21 years or older than 65 years who have had adequate prior screening and are not at high risk for cervical cancer. Cervical cancer screening is also not recommended for women who have had a hysterectomy with removal of the cervix and no personal history of cervical intraepithelial neoplasia grade 2 or 3 within the past 20 years.
Recommendation 4: Contraception
Adolescent and adult women should have access to the full range of US Food and Drug Administration–approved female-controlled contraceptives to prevent unintended pregnancy and improve birth outcomes. Multiple visits with a clinician may be needed to select an optimal contraceptive.
Recommendation 5: Screening for gestational diabetes mellitus
Pregnant women should be screened for GDM between 24 and 28 weeks’ gestation to prevent adverse birth outcomes. Screening should be performed with a “50 gm oral glucose challenge test followed by a 3-hour 100 gm oral glucose tolerance test” if the results on the initial oral glucose tolerance test are abnormal. This testing sequence has high sensitivity and specificity. Women with risk factors for diabetes mellitus should be screened for diabetes at the first prenatal visit using current best clinical practice.
Recommendation 6: Screening for human immunodeficiency virus (HIV) infection
Adolescents and women should receive education and risk assessment for HIV annually and should be tested for HIV at least once during their lifetime. Based on assessed risk, screening annually may be appropriate. “Screening for HIV is recommended for all pregnant women upon initiation of prenatal care with retesting during pregnancy based on risk factors. Rapid HIV testing is recommended for pregnant women who present in active labor with an undocumented HIV status.” Risk-based screening does not identify approximately 20% of HIV-infected people. Hence screening annually may be reasonable.
Recommendation 7: Screening for interpersonal and domestic violence
All adolescents and women should be screened annually for both interpersonal violence (IPV) and domestic violence (DV). Intervention services should be available to all adolescents and women. IPV and DV are prevalent problems, and they are often undetected by clinicians. Hence annual screening is recommended.
Recommendation 8: Counseling for sexually transmitted infections
Adolescents and women should be assessed for sexually transmittedinfection (STI) risk. Risk factors include:
- “age younger than 25 years,
- a recent STI,
- a new sex partner,
- multiple partners,
- a partner with concurrent partners,
- a partner with an STI, and
- a lack of or inconsistent condom use.”
Women at increased risk for an STI should receive behavioral counseling.
Recommendation 9: Well-woman preventive visits
Women should “receive at least one preventive care visit per year beginning in adolescence and continuing across the lifespan to ensure that the recommended preventive services including preconception and many services necessary for prenatal and interconception care are obtained. The primary purpose of these visits is the delivery and coordination of recommended preventive services as determined by age and risk factors.”
- Abridged guidelines for the Women's Preventive Services Initiative can be found here: http://www.womenspreventivehealth.org/wp-content/uploads/2017/01/WPSI_2016AbridgedReport.pdf.
- Evidence-based summaries and appendices are available at this link: http://www.womenspreventivehealth.org/wp-content/uploads/2016/12/Evidence-Summaries-and-Appendices.pdf.
I plan on using these recommendations to guide my practice
Historically, many high-profile expert professional groups have developed their own women’s health services guidelines. The proliferation of conflicting guidelines confused both patients and clinicians. Dueling guidelines likely undermine public health because they result in confusion among patients and inconsistent care across the many disciplines that provide medical services to women.
The proliferation of conflicting guidelines for mammography screening for breast cancer is a good example of how dueling guidelines can undermine public health (TABLE).4−7 The WPSI has done a great service to women and clinicians by creating a shared framework for consistently providing critical services across a woman’s entire life. I plan on using these recommendations to guide my practice. Patients and clinicians will greatly benefit from the exceptionally thoughtful women’s preventive services guidelines provided by the WPSI.
Share your thoughts! Send your Letter to the Editor to rbarbieri@frontlinemedcom.com. Please include your name and the city and state in which you practice.
- Institute of Medicine. Clinical preventive services for women: closing the gaps. Washington DC: The National Academies Press; 2011. http://nap.edu/13181. Accessed January 16, 2017.
- American Congress of Obstetricians and Gynecologists (ACOG). Women's Preventive Services Initiative (WPSI). http://www.acog.org/About-ACOG/ACOG-Departments/Annual-Womens-Health-Care/Womens-Preventive-Services-Initiative. Accessed January 16, 2017.
- Health Resources and Services Administration website. Women's preventive services guidelines. https://www.hrsa.gov/womensguidelines/. Accessed January 16, 2017.
- American College of Obstetricians and Gynecologists. Practice bulletin no. 122: breast cancer screening. Obstet Gynecol. 2011;118(2 pt 1):372-382.
- Oeffinger KC, Fontham ET, Etzioni R, et al. Breast cancer screening for women at average risk: 2015 guideline update from the American Cancer Society. JAMA. 2015;314(15):1599-1614.
- American Academy of Family Physicians website. Clinical preventive service recommendation: breast cancer. http://www.aafp.org/patient-care/clinical-recommendations/all/breast-cancer.html. Accessed January 16, 2017.
- US Preventive Services Task Force. Screening for breast cancer: U.S. Preventive Services Task Force recommendation statement. Ann Intern Med. 2009;151(10):716-726.
- Institute of Medicine. Clinical preventive services for women: closing the gaps. Washington DC: The National Academies Press; 2011. http://nap.edu/13181. Accessed January 16, 2017.
- American Congress of Obstetricians and Gynecologists (ACOG). Women's Preventive Services Initiative (WPSI). http://www.acog.org/About-ACOG/ACOG-Departments/Annual-Womens-Health-Care/Womens-Preventive-Services-Initiative. Accessed January 16, 2017.
- Health Resources and Services Administration website. Women's preventive services guidelines. https://www.hrsa.gov/womensguidelines/. Accessed January 16, 2017.
- American College of Obstetricians and Gynecologists. Practice bulletin no. 122: breast cancer screening. Obstet Gynecol. 2011;118(2 pt 1):372-382.
- Oeffinger KC, Fontham ET, Etzioni R, et al. Breast cancer screening for women at average risk: 2015 guideline update from the American Cancer Society. JAMA. 2015;314(15):1599-1614.
- American Academy of Family Physicians website. Clinical preventive service recommendation: breast cancer. http://www.aafp.org/patient-care/clinical-recommendations/all/breast-cancer.html. Accessed January 16, 2017.
- US Preventive Services Task Force. Screening for breast cancer: U.S. Preventive Services Task Force recommendation statement. Ann Intern Med. 2009;151(10):716-726.
Letters to the Editor: Your patients are talking: Isn’t it time you take responsibility for your online reputation?
“YOUR PATIENTS ARE TALKING: ISN’T IT TIME YOU TAKE RESPONSIBILITY FOR YOUR ONLINE REPUTATION?”
RON ROMANO AND NEIL H. BAUM, MD (NOVEMBER 2016)
Eschews meaningless Internet obfuscation
As a practicing physician I don’t have time for social media and its accompanying advertising rationale; it’s a wasteland that replaces television. My patients and I go one-on-one, eye-to-eye, and eschew meaningless Internet obfuscation. Don’t we have better things to do with our physician/patient relationship than check online reviews?
Warren Kendall, MD
Grants Pass, Oregon
Share your thoughts! Send your Letter to the Editor to rbarbieri@frontlinemedcom.com. Please include your name and the city and state in which you practice.
“YOUR PATIENTS ARE TALKING: ISN’T IT TIME YOU TAKE RESPONSIBILITY FOR YOUR ONLINE REPUTATION?”
RON ROMANO AND NEIL H. BAUM, MD (NOVEMBER 2016)
Eschews meaningless Internet obfuscation
As a practicing physician I don’t have time for social media and its accompanying advertising rationale; it’s a wasteland that replaces television. My patients and I go one-on-one, eye-to-eye, and eschew meaningless Internet obfuscation. Don’t we have better things to do with our physician/patient relationship than check online reviews?
Warren Kendall, MD
Grants Pass, Oregon
Share your thoughts! Send your Letter to the Editor to rbarbieri@frontlinemedcom.com. Please include your name and the city and state in which you practice.
“YOUR PATIENTS ARE TALKING: ISN’T IT TIME YOU TAKE RESPONSIBILITY FOR YOUR ONLINE REPUTATION?”
RON ROMANO AND NEIL H. BAUM, MD (NOVEMBER 2016)
Eschews meaningless Internet obfuscation
As a practicing physician I don’t have time for social media and its accompanying advertising rationale; it’s a wasteland that replaces television. My patients and I go one-on-one, eye-to-eye, and eschew meaningless Internet obfuscation. Don’t we have better things to do with our physician/patient relationship than check online reviews?
Warren Kendall, MD
Grants Pass, Oregon
Share your thoughts! Send your Letter to the Editor to rbarbieri@frontlinemedcom.com. Please include your name and the city and state in which you practice.
Letters to the Editor: Should we change instruments and gloves after closing the uterus?
“PREVENTING INFECTION AFTER CESAREAN DELIVERY: 5 MORE EVIDENCE-BASED MEASURES TO CONSIDER”
KATHRYN E. PATRICK, MD; SARA L. DEATSMAN, MD; AND PATRICK DUFF, MD (DECEMEBER 2016)
Should we change instruments and gloves after closing the uterus?
In reference to the recent article series on preventing infection after cesarean delivery by Drs. Patrick, Deatsman, and Duff, what are the thoughts on using clean instruments and changing gloves after closing the uterus?
Gerrit J. Schipper, MD
Frederick, Maryland
❯❯ Drs. Patrick, Deatsman, and Duff respond:
We appreciate Dr. Schipper’s thoughtful question concerning our recent articles. At present, we are not aware of any rigorous studies that have evaluated the possible protective effect of changing to a different set of surgical instruments after closure of the uterus.
The second part of the question concerning the effect of changing gloves at a certain point in the operation is more intriguing. In an earlier report from our institution, we showed that the dominant hand of the operator becomes heavily contaminated with bacteria during the process of extracting the fetal head from the lower uterine segment.1 The contamination is particularly heavy when the patient has had an extended duration of labor in the presence of ruptured membranes. In a subsequent investigation, we showed that avoidance of manual extraction of the placenta, a process in which the now-contaminated glove of the operator is placed between the placenta and the uterine wall, significantly reduced the frequency of postcesarean endometritis even in patients who already were receiving systemic antibiotic prophylaxis.2 Whether changing gloves after delivery of the baby will further decrease the frequency of postcesarean endometritis, beyond that which can be achieved with systemic antibiotic prophylaxis combined with delivery of the placenta by traction on the cord, has not been studied in a systematic manner.
Given the low frequency of infection that can be achieved with these 2 methods, it would require a very large sample size to show that glove change offered an additional protective effect. Nevertheless, on a practical basis, we think it is very reasonable to change the glove on the dominant hand following a difficult extraction of the presenting part in a patient who has had an extended duration of labor and ruptured membranes. The glove change is particularly important if manual extraction of the placenta is contemplated.
Of note, we would like to acknowledge that the US Food and Drug Administration finalized a ban on the use of powdered surgical gloves effective January 18, 2017.3 The aerosolized glove powder on latex gloves contains proteins that can provoke severe respiratory allergic reactions in patients who are sensitive to latex. Even powdered synthetic gloves can cause airway inflammation, wound inflammation, and postoperative adhesions.
“DOES ONE PARTICULAR CESAREAN TECHNIQUE CONFER BETTER MATERNAL AND NEONATAL OUTCOMES?”
JOHN M. THORP JR, MD (EXAMINING THE EVIDENCE; NOVEMBER 2016)
Choosing a cesarean technique based on “evidence”
I appreciate the commentary by Dr. Thorp concerning cesarean delivery techniques. I have always thought that there was no difference in the outcomes of the various techniques. However, we will continue to waver to the peer pressure of this evidence-based stuff—until we find out later, like now—until things change again. “The more things change, the more they remain the same.”
Dr. Smart Ebinne
Port Harcourt, Nigeria
Share your thoughts! Send your Letter to the Editor to rbarbieri@frontlinemedcom.com. Please include your name and the city and state in which you practice.
- Yancey MK, Clark P, Duff P. The frequency of glove contamination during cesarean delivery. Obstet Gynecol. 1994;83(4):538–542.
- Lasley DS, Eblen A, Yancey MK, Duff P. The effect of placental removal method on the incidence of postcesarean infections. Am J Obstet Gynecol. 1997;176(6):1250–1254.
- US Food and Drug Administration. Banned devices; powdered surgeon’s gloves, powdered patient examination gloves, and absorbable powder for lubricating a surgeon’s glove. Final rule. Fed Regist. 2016;81(243):91722–91731.
“PREVENTING INFECTION AFTER CESAREAN DELIVERY: 5 MORE EVIDENCE-BASED MEASURES TO CONSIDER”
KATHRYN E. PATRICK, MD; SARA L. DEATSMAN, MD; AND PATRICK DUFF, MD (DECEMEBER 2016)
Should we change instruments and gloves after closing the uterus?
In reference to the recent article series on preventing infection after cesarean delivery by Drs. Patrick, Deatsman, and Duff, what are the thoughts on using clean instruments and changing gloves after closing the uterus?
Gerrit J. Schipper, MD
Frederick, Maryland
❯❯ Drs. Patrick, Deatsman, and Duff respond:
We appreciate Dr. Schipper’s thoughtful question concerning our recent articles. At present, we are not aware of any rigorous studies that have evaluated the possible protective effect of changing to a different set of surgical instruments after closure of the uterus.
The second part of the question concerning the effect of changing gloves at a certain point in the operation is more intriguing. In an earlier report from our institution, we showed that the dominant hand of the operator becomes heavily contaminated with bacteria during the process of extracting the fetal head from the lower uterine segment.1 The contamination is particularly heavy when the patient has had an extended duration of labor in the presence of ruptured membranes. In a subsequent investigation, we showed that avoidance of manual extraction of the placenta, a process in which the now-contaminated glove of the operator is placed between the placenta and the uterine wall, significantly reduced the frequency of postcesarean endometritis even in patients who already were receiving systemic antibiotic prophylaxis.2 Whether changing gloves after delivery of the baby will further decrease the frequency of postcesarean endometritis, beyond that which can be achieved with systemic antibiotic prophylaxis combined with delivery of the placenta by traction on the cord, has not been studied in a systematic manner.
Given the low frequency of infection that can be achieved with these 2 methods, it would require a very large sample size to show that glove change offered an additional protective effect. Nevertheless, on a practical basis, we think it is very reasonable to change the glove on the dominant hand following a difficult extraction of the presenting part in a patient who has had an extended duration of labor and ruptured membranes. The glove change is particularly important if manual extraction of the placenta is contemplated.
Of note, we would like to acknowledge that the US Food and Drug Administration finalized a ban on the use of powdered surgical gloves effective January 18, 2017.3 The aerosolized glove powder on latex gloves contains proteins that can provoke severe respiratory allergic reactions in patients who are sensitive to latex. Even powdered synthetic gloves can cause airway inflammation, wound inflammation, and postoperative adhesions.
“DOES ONE PARTICULAR CESAREAN TECHNIQUE CONFER BETTER MATERNAL AND NEONATAL OUTCOMES?”
JOHN M. THORP JR, MD (EXAMINING THE EVIDENCE; NOVEMBER 2016)
Choosing a cesarean technique based on “evidence”
I appreciate the commentary by Dr. Thorp concerning cesarean delivery techniques. I have always thought that there was no difference in the outcomes of the various techniques. However, we will continue to waver to the peer pressure of this evidence-based stuff—until we find out later, like now—until things change again. “The more things change, the more they remain the same.”
Dr. Smart Ebinne
Port Harcourt, Nigeria
Share your thoughts! Send your Letter to the Editor to rbarbieri@frontlinemedcom.com. Please include your name and the city and state in which you practice.
“PREVENTING INFECTION AFTER CESAREAN DELIVERY: 5 MORE EVIDENCE-BASED MEASURES TO CONSIDER”
KATHRYN E. PATRICK, MD; SARA L. DEATSMAN, MD; AND PATRICK DUFF, MD (DECEMEBER 2016)
Should we change instruments and gloves after closing the uterus?
In reference to the recent article series on preventing infection after cesarean delivery by Drs. Patrick, Deatsman, and Duff, what are the thoughts on using clean instruments and changing gloves after closing the uterus?
Gerrit J. Schipper, MD
Frederick, Maryland
❯❯ Drs. Patrick, Deatsman, and Duff respond:
We appreciate Dr. Schipper’s thoughtful question concerning our recent articles. At present, we are not aware of any rigorous studies that have evaluated the possible protective effect of changing to a different set of surgical instruments after closure of the uterus.
The second part of the question concerning the effect of changing gloves at a certain point in the operation is more intriguing. In an earlier report from our institution, we showed that the dominant hand of the operator becomes heavily contaminated with bacteria during the process of extracting the fetal head from the lower uterine segment.1 The contamination is particularly heavy when the patient has had an extended duration of labor in the presence of ruptured membranes. In a subsequent investigation, we showed that avoidance of manual extraction of the placenta, a process in which the now-contaminated glove of the operator is placed between the placenta and the uterine wall, significantly reduced the frequency of postcesarean endometritis even in patients who already were receiving systemic antibiotic prophylaxis.2 Whether changing gloves after delivery of the baby will further decrease the frequency of postcesarean endometritis, beyond that which can be achieved with systemic antibiotic prophylaxis combined with delivery of the placenta by traction on the cord, has not been studied in a systematic manner.
Given the low frequency of infection that can be achieved with these 2 methods, it would require a very large sample size to show that glove change offered an additional protective effect. Nevertheless, on a practical basis, we think it is very reasonable to change the glove on the dominant hand following a difficult extraction of the presenting part in a patient who has had an extended duration of labor and ruptured membranes. The glove change is particularly important if manual extraction of the placenta is contemplated.
Of note, we would like to acknowledge that the US Food and Drug Administration finalized a ban on the use of powdered surgical gloves effective January 18, 2017.3 The aerosolized glove powder on latex gloves contains proteins that can provoke severe respiratory allergic reactions in patients who are sensitive to latex. Even powdered synthetic gloves can cause airway inflammation, wound inflammation, and postoperative adhesions.
“DOES ONE PARTICULAR CESAREAN TECHNIQUE CONFER BETTER MATERNAL AND NEONATAL OUTCOMES?”
JOHN M. THORP JR, MD (EXAMINING THE EVIDENCE; NOVEMBER 2016)
Choosing a cesarean technique based on “evidence”
I appreciate the commentary by Dr. Thorp concerning cesarean delivery techniques. I have always thought that there was no difference in the outcomes of the various techniques. However, we will continue to waver to the peer pressure of this evidence-based stuff—until we find out later, like now—until things change again. “The more things change, the more they remain the same.”
Dr. Smart Ebinne
Port Harcourt, Nigeria
Share your thoughts! Send your Letter to the Editor to rbarbieri@frontlinemedcom.com. Please include your name and the city and state in which you practice.
- Yancey MK, Clark P, Duff P. The frequency of glove contamination during cesarean delivery. Obstet Gynecol. 1994;83(4):538–542.
- Lasley DS, Eblen A, Yancey MK, Duff P. The effect of placental removal method on the incidence of postcesarean infections. Am J Obstet Gynecol. 1997;176(6):1250–1254.
- US Food and Drug Administration. Banned devices; powdered surgeon’s gloves, powdered patient examination gloves, and absorbable powder for lubricating a surgeon’s glove. Final rule. Fed Regist. 2016;81(243):91722–91731.
- Yancey MK, Clark P, Duff P. The frequency of glove contamination during cesarean delivery. Obstet Gynecol. 1994;83(4):538–542.
- Lasley DS, Eblen A, Yancey MK, Duff P. The effect of placental removal method on the incidence of postcesarean infections. Am J Obstet Gynecol. 1997;176(6):1250–1254.
- US Food and Drug Administration. Banned devices; powdered surgeon’s gloves, powdered patient examination gloves, and absorbable powder for lubricating a surgeon’s glove. Final rule. Fed Regist. 2016;81(243):91722–91731.
Disrupted placenta: Infant anemia
Disrupted placenta: Infant anemia
An Obgyn recommended an elective transverse low incision cesarean delivery at a prenatal visit. Due to severe weather, the ObGyn was unable to come to the hospital; an on-call ObGyn consulted with the ObGyn by phone. Cesarean delivery resulted in disruption of the placenta. When the infant’s blood gasses test results were abnormal, he was transferred to the neonatal intensive care unit, where anemia was diagnosed. The infant was hospitalized for 31 days.
PARENTS’ CLAIM:
The on-call ObGyn caused the child’s injury by performing a transverse low incision. A testifying radiology expert said that ultrasonography (US) taken 5 weeks before delivery showed an anterior low-lying placenta but a clear field existed that would have allowed a vertical incision without placental disruption.
PHYSICIAN’S DEFENSE:
The delivery was within the standard of care. The ObGyn did not have access to the US cited by the testifying radiologist; standard of care did not require that she have access to them. A transverse incision minimizes blood loss; a vertical incision would have disrupted a larger area of placenta. The infant had normal blood gasses at delivery; any injury was not related to placental disruption.
VERDICT:
A Virginia defense verdict was returned.
Child has spastic CP after long labor
A 17-year-old woman's baby was delivered using vacuum extraction after a prolonged labor. Two days after birth, US results revealed diffuse brain edema in the baby. Magnetic resonance imaging demonstrated an absence of brain parenchyma in the left and right hemispheres. The baby received a diagnosis of spastic cerebral palsy (CP). She has little voluntary movement and requires a feeding tube, a portable aspiration device, and in-home attendant care.
PARENT’S CLAIM:
The baby underwent a hypoxic ischemic event during labor. Four hospital physicians
DEFENDANTS’ DEFENSE:
The fetus did not have a fetal heart rate pattern that would have required an earlier delivery. The injury sustained by the baby was not compatible with a prolonged hypoxic event and was more likely caused by a genetic defect. The infant suffered a subacute brain injury at least 1 week before delivery.
VERDICT:
The hospital settled for $1.25 million. A California defense verdict was returned for the physicians.
Misdiagnosed ectopic pregnancy
After a home pregnancy test was positive, a 27-year-old woman reported vaginal spotting and cramping to her ObGyn. When no uterine contents showed on US, the ObGyn suspected an ectopic pregnancy and recommended termination of pregnancy. The woman requested another US; an appointment was scheduled for the next day. Instead of waiting, the woman went to an emergency department (ED) that night. Bloodwork confirmed the pregnancy but US results showed no evidence of an intrauterine pregnancy. The ED physician diagnosed an ectopic pregnancy. The on-call ObGyn concurred and recommended termination of pregnancy by surgical intervention or methotrexate. The patient chose methotrexate, which was administered, and she was discharged.
In the on-call ObGyn’s office a week later, the patient’s beta-hGC levels had not decreased. US revealed 2 intrauterine pregnancies, one with a heartbeat. The on-call ObGyn immediately referred the patient to a maternal-fetal medicine specialist. New US results showed evidence of an abnormal intrauterine pregnancy and a second gestational sac with no embryo. Two days later US showed a twin pregnancy: a 6-week fetal pole with no heartbeat and the other with no fetal pole or yolk sac. A dilation and curettage was performed.
PARENTS’ CLAIM:
The on-call ObGyn misdiagnosed an ectopic pregnancy, failed to order additional testing, and failed to observe the patient for 48 to 72 hours before administering methotrexate. This led to the loss of twins.
DEFENDANTS’ DEFENSE:
An ectopic pregnancy is an emergency that requires prompt diagnosis and treatment. There were sufficient signs for the on-call ObGyn to diagnose an ectopic pregnancy. She would have violated the standard of care if she had not administered treatment.
VERDICT:
The hospital settled for $127,000 before trial. An Illinois defense verdict was returned.
These cases were selected by the editors of OBG Management from Medical Malpractice Verdicts, Settlements & Experts, with permission of the editor, Lewis Laska (www.verdictslaska.com). The information available to the editors about the cases presented here is sometimes incomplete. Moreover, the cases may or may not have merit. Nevertheless, these cases represent the types of clinical situations that typically result in litigation and are meant to illustrate nationwide variation in jury verdicts and awards.
Share your thoughts! Send your Letter to the Editor to rbarbieri@frontlinemedcom.com. Please include your name and the city and state in which you practice.
Disrupted placenta: Infant anemia
An Obgyn recommended an elective transverse low incision cesarean delivery at a prenatal visit. Due to severe weather, the ObGyn was unable to come to the hospital; an on-call ObGyn consulted with the ObGyn by phone. Cesarean delivery resulted in disruption of the placenta. When the infant’s blood gasses test results were abnormal, he was transferred to the neonatal intensive care unit, where anemia was diagnosed. The infant was hospitalized for 31 days.
PARENTS’ CLAIM:
The on-call ObGyn caused the child’s injury by performing a transverse low incision. A testifying radiology expert said that ultrasonography (US) taken 5 weeks before delivery showed an anterior low-lying placenta but a clear field existed that would have allowed a vertical incision without placental disruption.
PHYSICIAN’S DEFENSE:
The delivery was within the standard of care. The ObGyn did not have access to the US cited by the testifying radiologist; standard of care did not require that she have access to them. A transverse incision minimizes blood loss; a vertical incision would have disrupted a larger area of placenta. The infant had normal blood gasses at delivery; any injury was not related to placental disruption.
VERDICT:
A Virginia defense verdict was returned.
Child has spastic CP after long labor
A 17-year-old woman's baby was delivered using vacuum extraction after a prolonged labor. Two days after birth, US results revealed diffuse brain edema in the baby. Magnetic resonance imaging demonstrated an absence of brain parenchyma in the left and right hemispheres. The baby received a diagnosis of spastic cerebral palsy (CP). She has little voluntary movement and requires a feeding tube, a portable aspiration device, and in-home attendant care.
PARENT’S CLAIM:
The baby underwent a hypoxic ischemic event during labor. Four hospital physicians
DEFENDANTS’ DEFENSE:
The fetus did not have a fetal heart rate pattern that would have required an earlier delivery. The injury sustained by the baby was not compatible with a prolonged hypoxic event and was more likely caused by a genetic defect. The infant suffered a subacute brain injury at least 1 week before delivery.
VERDICT:
The hospital settled for $1.25 million. A California defense verdict was returned for the physicians.
Misdiagnosed ectopic pregnancy
After a home pregnancy test was positive, a 27-year-old woman reported vaginal spotting and cramping to her ObGyn. When no uterine contents showed on US, the ObGyn suspected an ectopic pregnancy and recommended termination of pregnancy. The woman requested another US; an appointment was scheduled for the next day. Instead of waiting, the woman went to an emergency department (ED) that night. Bloodwork confirmed the pregnancy but US results showed no evidence of an intrauterine pregnancy. The ED physician diagnosed an ectopic pregnancy. The on-call ObGyn concurred and recommended termination of pregnancy by surgical intervention or methotrexate. The patient chose methotrexate, which was administered, and she was discharged.
In the on-call ObGyn’s office a week later, the patient’s beta-hGC levels had not decreased. US revealed 2 intrauterine pregnancies, one with a heartbeat. The on-call ObGyn immediately referred the patient to a maternal-fetal medicine specialist. New US results showed evidence of an abnormal intrauterine pregnancy and a second gestational sac with no embryo. Two days later US showed a twin pregnancy: a 6-week fetal pole with no heartbeat and the other with no fetal pole or yolk sac. A dilation and curettage was performed.
PARENTS’ CLAIM:
The on-call ObGyn misdiagnosed an ectopic pregnancy, failed to order additional testing, and failed to observe the patient for 48 to 72 hours before administering methotrexate. This led to the loss of twins.
DEFENDANTS’ DEFENSE:
An ectopic pregnancy is an emergency that requires prompt diagnosis and treatment. There were sufficient signs for the on-call ObGyn to diagnose an ectopic pregnancy. She would have violated the standard of care if she had not administered treatment.
VERDICT:
The hospital settled for $127,000 before trial. An Illinois defense verdict was returned.
These cases were selected by the editors of OBG Management from Medical Malpractice Verdicts, Settlements & Experts, with permission of the editor, Lewis Laska (www.verdictslaska.com). The information available to the editors about the cases presented here is sometimes incomplete. Moreover, the cases may or may not have merit. Nevertheless, these cases represent the types of clinical situations that typically result in litigation and are meant to illustrate nationwide variation in jury verdicts and awards.
Share your thoughts! Send your Letter to the Editor to rbarbieri@frontlinemedcom.com. Please include your name and the city and state in which you practice.
Disrupted placenta: Infant anemia
An Obgyn recommended an elective transverse low incision cesarean delivery at a prenatal visit. Due to severe weather, the ObGyn was unable to come to the hospital; an on-call ObGyn consulted with the ObGyn by phone. Cesarean delivery resulted in disruption of the placenta. When the infant’s blood gasses test results were abnormal, he was transferred to the neonatal intensive care unit, where anemia was diagnosed. The infant was hospitalized for 31 days.
PARENTS’ CLAIM:
The on-call ObGyn caused the child’s injury by performing a transverse low incision. A testifying radiology expert said that ultrasonography (US) taken 5 weeks before delivery showed an anterior low-lying placenta but a clear field existed that would have allowed a vertical incision without placental disruption.
PHYSICIAN’S DEFENSE:
The delivery was within the standard of care. The ObGyn did not have access to the US cited by the testifying radiologist; standard of care did not require that she have access to them. A transverse incision minimizes blood loss; a vertical incision would have disrupted a larger area of placenta. The infant had normal blood gasses at delivery; any injury was not related to placental disruption.
VERDICT:
A Virginia defense verdict was returned.
Child has spastic CP after long labor
A 17-year-old woman's baby was delivered using vacuum extraction after a prolonged labor. Two days after birth, US results revealed diffuse brain edema in the baby. Magnetic resonance imaging demonstrated an absence of brain parenchyma in the left and right hemispheres. The baby received a diagnosis of spastic cerebral palsy (CP). She has little voluntary movement and requires a feeding tube, a portable aspiration device, and in-home attendant care.
PARENT’S CLAIM:
The baby underwent a hypoxic ischemic event during labor. Four hospital physicians
DEFENDANTS’ DEFENSE:
The fetus did not have a fetal heart rate pattern that would have required an earlier delivery. The injury sustained by the baby was not compatible with a prolonged hypoxic event and was more likely caused by a genetic defect. The infant suffered a subacute brain injury at least 1 week before delivery.
VERDICT:
The hospital settled for $1.25 million. A California defense verdict was returned for the physicians.
Misdiagnosed ectopic pregnancy
After a home pregnancy test was positive, a 27-year-old woman reported vaginal spotting and cramping to her ObGyn. When no uterine contents showed on US, the ObGyn suspected an ectopic pregnancy and recommended termination of pregnancy. The woman requested another US; an appointment was scheduled for the next day. Instead of waiting, the woman went to an emergency department (ED) that night. Bloodwork confirmed the pregnancy but US results showed no evidence of an intrauterine pregnancy. The ED physician diagnosed an ectopic pregnancy. The on-call ObGyn concurred and recommended termination of pregnancy by surgical intervention or methotrexate. The patient chose methotrexate, which was administered, and she was discharged.
In the on-call ObGyn’s office a week later, the patient’s beta-hGC levels had not decreased. US revealed 2 intrauterine pregnancies, one with a heartbeat. The on-call ObGyn immediately referred the patient to a maternal-fetal medicine specialist. New US results showed evidence of an abnormal intrauterine pregnancy and a second gestational sac with no embryo. Two days later US showed a twin pregnancy: a 6-week fetal pole with no heartbeat and the other with no fetal pole or yolk sac. A dilation and curettage was performed.
PARENTS’ CLAIM:
The on-call ObGyn misdiagnosed an ectopic pregnancy, failed to order additional testing, and failed to observe the patient for 48 to 72 hours before administering methotrexate. This led to the loss of twins.
DEFENDANTS’ DEFENSE:
An ectopic pregnancy is an emergency that requires prompt diagnosis and treatment. There were sufficient signs for the on-call ObGyn to diagnose an ectopic pregnancy. She would have violated the standard of care if she had not administered treatment.
VERDICT:
The hospital settled for $127,000 before trial. An Illinois defense verdict was returned.
These cases were selected by the editors of OBG Management from Medical Malpractice Verdicts, Settlements & Experts, with permission of the editor, Lewis Laska (www.verdictslaska.com). The information available to the editors about the cases presented here is sometimes incomplete. Moreover, the cases may or may not have merit. Nevertheless, these cases represent the types of clinical situations that typically result in litigation and are meant to illustrate nationwide variation in jury verdicts and awards.
Share your thoughts! Send your Letter to the Editor to rbarbieri@frontlinemedcom.com. Please include your name and the city and state in which you practice.
Strategies for prophylactic oophoropexy

Visit the Society of Gynecologic Surgeons online: sgsonline.org
More videos from SGS:
- Tips and tricks for open laparoscopy
- Complete colpectomy & colpocleisis: Model for simulation
- Natural orifice sacral colpopexy
- Alternative options for visualizing ureteral patency during intraoperative cystoscopy
- Use of suprapubic Carter-Thomason needle to assist in cystoscopic excision of an intravesical foreign object
- Uterine artery ligation: Advanced techniques and considerations for the difficult laparoscopic hysterectomy
- Cervical injection of methylene blue for identification of sentinel lymph nodes in cervical cancer
- Misplaced hysteroscopic sterilization micro-insert in the peritoneal cavity: A corpus alienum
- Laparoscopic cystectomy for large, bilateral ovarian dermoids
- Small bowel surgery for the benign gynecologist

Visit the Society of Gynecologic Surgeons online: sgsonline.org
More videos from SGS:
- Tips and tricks for open laparoscopy
- Complete colpectomy & colpocleisis: Model for simulation
- Natural orifice sacral colpopexy
- Alternative options for visualizing ureteral patency during intraoperative cystoscopy
- Use of suprapubic Carter-Thomason needle to assist in cystoscopic excision of an intravesical foreign object
- Uterine artery ligation: Advanced techniques and considerations for the difficult laparoscopic hysterectomy
- Cervical injection of methylene blue for identification of sentinel lymph nodes in cervical cancer
- Misplaced hysteroscopic sterilization micro-insert in the peritoneal cavity: A corpus alienum
- Laparoscopic cystectomy for large, bilateral ovarian dermoids
- Small bowel surgery for the benign gynecologist

Visit the Society of Gynecologic Surgeons online: sgsonline.org
More videos from SGS:
- Tips and tricks for open laparoscopy
- Complete colpectomy & colpocleisis: Model for simulation
- Natural orifice sacral colpopexy
- Alternative options for visualizing ureteral patency during intraoperative cystoscopy
- Use of suprapubic Carter-Thomason needle to assist in cystoscopic excision of an intravesical foreign object
- Uterine artery ligation: Advanced techniques and considerations for the difficult laparoscopic hysterectomy
- Cervical injection of methylene blue for identification of sentinel lymph nodes in cervical cancer
- Misplaced hysteroscopic sterilization micro-insert in the peritoneal cavity: A corpus alienum
- Laparoscopic cystectomy for large, bilateral ovarian dermoids
- Small bowel surgery for the benign gynecologist
This video is brought to you by
2-week left-sided pelvic pain
(A) Simple ovarian cyst INCORRECT
Here is an example of a well circumscribed round or oval anechoic, avascular simple ovarian cyst with posterior acoustic enhancement and thin smooth walls.1 No septations or solid components are identified.
(B) Hemorrhagic cyst CORRECT
This type of cyst is well circumscribed and hypoechoic, with posterior acoustic enhancement and demonstrates a lacy reticular pattern of internal echoes due to fibrin strands (long arrow). The internal echoes also may be solid appearing with concave margins (short arrow) due to retractile hemorrhagic clot.1 The absence of internal vascular flow on color Doppler helps differentiate it from the solid components seen in ovarian neoplasm.
(C) Endometrioma INCORRECT
This mass is a well-circumscribed hypoechoic cyst with homogeneous ground glass or low level echoes and increased through transmission.1 It is also avascular without solid components.
(D) Dermoid INCORRECT
This common benign ovarian tumor has varying appearances. The most common appearance is a cystic lesion with a focal echogenic nodule (long arrow) protruding into the cyst (Rokitansky nodule).2 The second most common appearance is a focal or diffuse hyperechoic mass with areas of acoustic shadowing (arrowhead) from the sebaceous material and hair (tip of the iceberg sign). A third common appearance is a cystic lesion with multiple thin echogenic bands (lines and dots), which are hair floating within the cyst (short arrow). There is no internal vascular flow identified.
(E) Cystic ovarian neoplasm INCORRECT
These are large complex masses with both cystic and solid components demonstrating internal vascular flow. They usually demonstrate a thick irregular wall, multiple septations, and nodular papillary projections.3
- Levine D, Brown DL, Andreotti RF, et al. Management of asymptomatic ovarian and other adnexal cysts imaged at US Society of Radiologists in Ultrasound consensus conference statement. Radiology. 2010;256:(3):943−954.
- Outwater EK, Siegelman ES, Hunt JL. Ovarian teratomas: tumor types and imaging characteristics. Radiographics. 2001;21(2):475−490.
- Wasnik AP, Menias CO, Platt JF, Lalchandani UR, Bedi DG, Elsayes KM. Multimodality imaging of ovarian cystic lesions: review with an imaging based algorithmic approach. World J Radiol. 2013;5(3):113−125.
(A) Simple ovarian cyst INCORRECT
Here is an example of a well circumscribed round or oval anechoic, avascular simple ovarian cyst with posterior acoustic enhancement and thin smooth walls.1 No septations or solid components are identified.
(B) Hemorrhagic cyst CORRECT
This type of cyst is well circumscribed and hypoechoic, with posterior acoustic enhancement and demonstrates a lacy reticular pattern of internal echoes due to fibrin strands (long arrow). The internal echoes also may be solid appearing with concave margins (short arrow) due to retractile hemorrhagic clot.1 The absence of internal vascular flow on color Doppler helps differentiate it from the solid components seen in ovarian neoplasm.
(C) Endometrioma INCORRECT
This mass is a well-circumscribed hypoechoic cyst with homogeneous ground glass or low level echoes and increased through transmission.1 It is also avascular without solid components.
(D) Dermoid INCORRECT
This common benign ovarian tumor has varying appearances. The most common appearance is a cystic lesion with a focal echogenic nodule (long arrow) protruding into the cyst (Rokitansky nodule).2 The second most common appearance is a focal or diffuse hyperechoic mass with areas of acoustic shadowing (arrowhead) from the sebaceous material and hair (tip of the iceberg sign). A third common appearance is a cystic lesion with multiple thin echogenic bands (lines and dots), which are hair floating within the cyst (short arrow). There is no internal vascular flow identified.
(E) Cystic ovarian neoplasm INCORRECT
These are large complex masses with both cystic and solid components demonstrating internal vascular flow. They usually demonstrate a thick irregular wall, multiple septations, and nodular papillary projections.3
(A) Simple ovarian cyst INCORRECT
Here is an example of a well circumscribed round or oval anechoic, avascular simple ovarian cyst with posterior acoustic enhancement and thin smooth walls.1 No septations or solid components are identified.
(B) Hemorrhagic cyst CORRECT
This type of cyst is well circumscribed and hypoechoic, with posterior acoustic enhancement and demonstrates a lacy reticular pattern of internal echoes due to fibrin strands (long arrow). The internal echoes also may be solid appearing with concave margins (short arrow) due to retractile hemorrhagic clot.1 The absence of internal vascular flow on color Doppler helps differentiate it from the solid components seen in ovarian neoplasm.
(C) Endometrioma INCORRECT
This mass is a well-circumscribed hypoechoic cyst with homogeneous ground glass or low level echoes and increased through transmission.1 It is also avascular without solid components.
(D) Dermoid INCORRECT
This common benign ovarian tumor has varying appearances. The most common appearance is a cystic lesion with a focal echogenic nodule (long arrow) protruding into the cyst (Rokitansky nodule).2 The second most common appearance is a focal or diffuse hyperechoic mass with areas of acoustic shadowing (arrowhead) from the sebaceous material and hair (tip of the iceberg sign). A third common appearance is a cystic lesion with multiple thin echogenic bands (lines and dots), which are hair floating within the cyst (short arrow). There is no internal vascular flow identified.
(E) Cystic ovarian neoplasm INCORRECT
These are large complex masses with both cystic and solid components demonstrating internal vascular flow. They usually demonstrate a thick irregular wall, multiple septations, and nodular papillary projections.3
- Levine D, Brown DL, Andreotti RF, et al. Management of asymptomatic ovarian and other adnexal cysts imaged at US Society of Radiologists in Ultrasound consensus conference statement. Radiology. 2010;256:(3):943−954.
- Outwater EK, Siegelman ES, Hunt JL. Ovarian teratomas: tumor types and imaging characteristics. Radiographics. 2001;21(2):475−490.
- Wasnik AP, Menias CO, Platt JF, Lalchandani UR, Bedi DG, Elsayes KM. Multimodality imaging of ovarian cystic lesions: review with an imaging based algorithmic approach. World J Radiol. 2013;5(3):113−125.
- Levine D, Brown DL, Andreotti RF, et al. Management of asymptomatic ovarian and other adnexal cysts imaged at US Society of Radiologists in Ultrasound consensus conference statement. Radiology. 2010;256:(3):943−954.
- Outwater EK, Siegelman ES, Hunt JL. Ovarian teratomas: tumor types and imaging characteristics. Radiographics. 2001;21(2):475−490.
- Wasnik AP, Menias CO, Platt JF, Lalchandani UR, Bedi DG, Elsayes KM. Multimodality imaging of ovarian cystic lesions: review with an imaging based algorithmic approach. World J Radiol. 2013;5(3):113−125.
A 37-year-old woman presents to the emergency department reporting left-sided pelvic pain for 2 weeks duration. She has a negative urine pregnancy test. Pelvic ultrasonography of the left adnexa is performed with gray scale (A) and color Doppler images (B). Figures shown above.
Top 3 things I learned at the PAGS 2016 symposium
The video associated with this article is no longer available on this site. Please view all of our videos on the MDedge YouTube channel
The video associated with this article is no longer available on this site. Please view all of our videos on the MDedge YouTube channel
The video associated with this article is no longer available on this site. Please view all of our videos on the MDedge YouTube channel
Webcast: Emergency contraception: How to choose the right one for your patient
The video associated with this article is no longer available on this site. Please view all of our videos on the MDedge YouTube channel
Access Dr. Burkman's Webcasts on contraception:
- Contraceptive considerations for women with headache and migraine
- Hormonal contraception and risk of venous thromboembolism
- Oral contraceptives and breast cancer: What’s the risk?
- Factors that contribute to overall contraceptive efficacy and risks
- Obesity and contraceptive efficacy and risks
- How to use the CDC's online tools to manage complex cases in contraception
Helpful resources for your practice:
- United States Medical Eligibility Criteria for Contraceptive Use, 2016
- United States Medical Eligibility Criteria (US MEC) for Contraceptive Use, 2010
- Summary Chart of US Medical Eligibility for Contraceptive Use
- Book recommendation: Allen RH, Cwiak CA, eds. Contraception for the medically challenging patient. New York, New York: Springer New York; 2014.
The video associated with this article is no longer available on this site. Please view all of our videos on the MDedge YouTube channel
Access Dr. Burkman's Webcasts on contraception:
- Contraceptive considerations for women with headache and migraine
- Hormonal contraception and risk of venous thromboembolism
- Oral contraceptives and breast cancer: What’s the risk?
- Factors that contribute to overall contraceptive efficacy and risks
- Obesity and contraceptive efficacy and risks
- How to use the CDC's online tools to manage complex cases in contraception
Helpful resources for your practice:
- United States Medical Eligibility Criteria for Contraceptive Use, 2016
- United States Medical Eligibility Criteria (US MEC) for Contraceptive Use, 2010
- Summary Chart of US Medical Eligibility for Contraceptive Use
- Book recommendation: Allen RH, Cwiak CA, eds. Contraception for the medically challenging patient. New York, New York: Springer New York; 2014.
The video associated with this article is no longer available on this site. Please view all of our videos on the MDedge YouTube channel
Access Dr. Burkman's Webcasts on contraception:
- Contraceptive considerations for women with headache and migraine
- Hormonal contraception and risk of venous thromboembolism
- Oral contraceptives and breast cancer: What’s the risk?
- Factors that contribute to overall contraceptive efficacy and risks
- Obesity and contraceptive efficacy and risks
- How to use the CDC's online tools to manage complex cases in contraception
Helpful resources for your practice:
- United States Medical Eligibility Criteria for Contraceptive Use, 2016
- United States Medical Eligibility Criteria (US MEC) for Contraceptive Use, 2010
- Summary Chart of US Medical Eligibility for Contraceptive Use
- Book recommendation: Allen RH, Cwiak CA, eds. Contraception for the medically challenging patient. New York, New York: Springer New York; 2014.