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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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Medical errors: Caring for the second victim (you)
Elective induction of labor at 39 (vs 41) weeks: Caveats and considerations
Tasked with tackling the literature on the subject and debating the question of whether or not it is best to electively induce labor in women with low-risk pregnancies at 39 weeks (vs at 41 weeks after expectant management), Errol Norwitz, MD, PhD, Chairman of the Department of Obstetrics and Gynecology and Professor at Tufts University School of Medicine in Boston, Massachusetts, and Charles Lockwood, MD, Senior Vice President at the University of South Florida (USF) and Dean of the USF Health Morsani College of Medicine in Tampa came to the same conclusion: Elective induction of labor (eIOL) at 39 weeks is superior to expectant management when it comes to fetal outcomes.
In addition, they both agreed that complication rates to the mother (ie, number of cesarean deliveries [CDs]) would not be increased, and possibly even reduced, with eIOL at 39 weeks versus 41 weeks. Dr. Norwitz postulated that, with IOL there is no increase in CD rate in multiparous women and nulliparous women with a favorable cervical exam but that there likely could be an increase in the CD rate for nulliparous women with an unfavorable cervical exam.
The finding that eIOL at 39 weeks is better than at 41 weeks for the infant is likely due to a bigger baby size past 39 weeks (with more traumatic deliveries) and higher rates of postmaturity complications, said Dr. Lockwood. And for the mother, eIOL at 39 weeks can reduce risks—of preeclampsia, abruption, sepsis, and others—the presenters pointed out.
Arriving at their conclusions: The dataDr. Norwitz explained the challenge before them in this unusual “debate.” “In ObGyn we all read the same literature but we often come away with very different takes as to what the implications are and how we incorporate this into our management algorithms. Instead of taking a pro/con approach, with one assigned to ‘yes’ and the other assigned to ‘no,’ and selectively picking out the literature to support our positions, what we did was we each went away, read the literature, synthesized it, and tried to answer this question for ourselves.”
Dr. Norwitz, who is widely published and known for his research on the causes and prevention of preeclampsia and preterm labor, examined and presented the published literature for benefit and harms to the fetus and mother in continuing pregnancy past 39 weeks.
Dr. Lockwood also examined the literature, including a large population cohort of about 1.27 million women that examined CD rates, perinatal mortality, and neonatal and maternal outcomes of eIOL at 39 weeks versus expectant management.1 He presented, however, that the best evidence to compare the question at hand would be a randomized clinical trial comparing specifically eIOL at 39 weeks versus expectant management, with IOL at 41 weeks. To be powered to detect a difference in perinatal and maternal mortality, this trial would need to include 2.2 to 12.6 million women, he maintained. “When empirical evidence doesn’t exist, the only alternative is some kind of other modeling,” he said. Therefore, he and a team of researchers conducted a Monte Carlo microsimulation modeling decision analysis, taking into account “all outcomes and all preferences that we possibly could cull from the literature.”
Which women actually could benefit from eIOL at 39 weeks?Women with high-risk pregnancies were not included in this debate or considered. Dr. Norwitz clearly defined his case patient at the outset as a 22-year-old G1 at 39 0/7 weeks who has had an uncomplicated pregnancy but is now complaining of decreased fetal movement and tells you that she is worried because her sister lost her baby at 40 weeks to stillbirth. She specifically asks, “Doctor, why can’t you induce my labor now?”
What counseling a patient about the risks/benefits of eIOL at 39 weeks would requireTwo fundamentals would need to be ensured. The first: precise gestational dating. Dr. Norwitz pointed out that menstrual history can be inaccurate, especially in women with irregular cycles, who are taking hormonal contraception, or who have intermenstrual bleeding. “Early dating ultrasound is the best way to date pregnancies and probably should be done routinely,” although it is not currently standard of care in the United States, he said.
The second fundamental: a true induction of labor process, not one that involves “stopping at 5 PM,” said Dr. Lockwood.
“Although Dr. Lockwood’s 5-PM statement was made tongue-in-cheek,” said Dr. Norwitz after the debate, “he certainly was implying that a genuine effort should be made to effect a vaginal delivery—that is, giving the most effective cervical ripening agents, allowing enough time to pass, and defining clearly the criteria for failed IOL. You shouldn’t just throw the towel in at 5 PM because you want to go home.”
Cost implicationsElectively inducing labor in all women with low-risk pregnancies at 39 weeks is a strategy with unknown cost implications, and the cost difference between this strategy and expectant management up to 41 weeks is not known.
“We need to be sure that we understand the cost implications of these strategies, which of course would need to be balanced against the potential perinatal and maternal morbidity and fetal death,” said Dr. Lockwood.
The meaning of “elective”Dr. Norwitz also made the point postdebate that the American College of Obstetricians and Gynecologists (ACOG) does not support elective IOL prior to 39 weeks’ gestation. “The key term here is ‘elective,’" he said, "which refers to a delivery without a clear medical or obstetric indication. ACOG does support delivery prior to 39 weeks’ gestation, there just needs to be an appropriate indication.”
1. Stock SJ, Ferguson E, Duffy A, Ford I, Chalmers J, Norman JE. Outcomes of elective induction of labour compared with expectant management: population based study. BMJ. 2012;344:e2838.
Tasked with tackling the literature on the subject and debating the question of whether or not it is best to electively induce labor in women with low-risk pregnancies at 39 weeks (vs at 41 weeks after expectant management), Errol Norwitz, MD, PhD, Chairman of the Department of Obstetrics and Gynecology and Professor at Tufts University School of Medicine in Boston, Massachusetts, and Charles Lockwood, MD, Senior Vice President at the University of South Florida (USF) and Dean of the USF Health Morsani College of Medicine in Tampa came to the same conclusion: Elective induction of labor (eIOL) at 39 weeks is superior to expectant management when it comes to fetal outcomes.
In addition, they both agreed that complication rates to the mother (ie, number of cesarean deliveries [CDs]) would not be increased, and possibly even reduced, with eIOL at 39 weeks versus 41 weeks. Dr. Norwitz postulated that, with IOL there is no increase in CD rate in multiparous women and nulliparous women with a favorable cervical exam but that there likely could be an increase in the CD rate for nulliparous women with an unfavorable cervical exam.
The finding that eIOL at 39 weeks is better than at 41 weeks for the infant is likely due to a bigger baby size past 39 weeks (with more traumatic deliveries) and higher rates of postmaturity complications, said Dr. Lockwood. And for the mother, eIOL at 39 weeks can reduce risks—of preeclampsia, abruption, sepsis, and others—the presenters pointed out.
Arriving at their conclusions: The dataDr. Norwitz explained the challenge before them in this unusual “debate.” “In ObGyn we all read the same literature but we often come away with very different takes as to what the implications are and how we incorporate this into our management algorithms. Instead of taking a pro/con approach, with one assigned to ‘yes’ and the other assigned to ‘no,’ and selectively picking out the literature to support our positions, what we did was we each went away, read the literature, synthesized it, and tried to answer this question for ourselves.”
Dr. Norwitz, who is widely published and known for his research on the causes and prevention of preeclampsia and preterm labor, examined and presented the published literature for benefit and harms to the fetus and mother in continuing pregnancy past 39 weeks.
Dr. Lockwood also examined the literature, including a large population cohort of about 1.27 million women that examined CD rates, perinatal mortality, and neonatal and maternal outcomes of eIOL at 39 weeks versus expectant management.1 He presented, however, that the best evidence to compare the question at hand would be a randomized clinical trial comparing specifically eIOL at 39 weeks versus expectant management, with IOL at 41 weeks. To be powered to detect a difference in perinatal and maternal mortality, this trial would need to include 2.2 to 12.6 million women, he maintained. “When empirical evidence doesn’t exist, the only alternative is some kind of other modeling,” he said. Therefore, he and a team of researchers conducted a Monte Carlo microsimulation modeling decision analysis, taking into account “all outcomes and all preferences that we possibly could cull from the literature.”
Which women actually could benefit from eIOL at 39 weeks?Women with high-risk pregnancies were not included in this debate or considered. Dr. Norwitz clearly defined his case patient at the outset as a 22-year-old G1 at 39 0/7 weeks who has had an uncomplicated pregnancy but is now complaining of decreased fetal movement and tells you that she is worried because her sister lost her baby at 40 weeks to stillbirth. She specifically asks, “Doctor, why can’t you induce my labor now?”
What counseling a patient about the risks/benefits of eIOL at 39 weeks would requireTwo fundamentals would need to be ensured. The first: precise gestational dating. Dr. Norwitz pointed out that menstrual history can be inaccurate, especially in women with irregular cycles, who are taking hormonal contraception, or who have intermenstrual bleeding. “Early dating ultrasound is the best way to date pregnancies and probably should be done routinely,” although it is not currently standard of care in the United States, he said.
The second fundamental: a true induction of labor process, not one that involves “stopping at 5 PM,” said Dr. Lockwood.
“Although Dr. Lockwood’s 5-PM statement was made tongue-in-cheek,” said Dr. Norwitz after the debate, “he certainly was implying that a genuine effort should be made to effect a vaginal delivery—that is, giving the most effective cervical ripening agents, allowing enough time to pass, and defining clearly the criteria for failed IOL. You shouldn’t just throw the towel in at 5 PM because you want to go home.”
Cost implicationsElectively inducing labor in all women with low-risk pregnancies at 39 weeks is a strategy with unknown cost implications, and the cost difference between this strategy and expectant management up to 41 weeks is not known.
“We need to be sure that we understand the cost implications of these strategies, which of course would need to be balanced against the potential perinatal and maternal morbidity and fetal death,” said Dr. Lockwood.
The meaning of “elective”Dr. Norwitz also made the point postdebate that the American College of Obstetricians and Gynecologists (ACOG) does not support elective IOL prior to 39 weeks’ gestation. “The key term here is ‘elective,’" he said, "which refers to a delivery without a clear medical or obstetric indication. ACOG does support delivery prior to 39 weeks’ gestation, there just needs to be an appropriate indication.”
Tasked with tackling the literature on the subject and debating the question of whether or not it is best to electively induce labor in women with low-risk pregnancies at 39 weeks (vs at 41 weeks after expectant management), Errol Norwitz, MD, PhD, Chairman of the Department of Obstetrics and Gynecology and Professor at Tufts University School of Medicine in Boston, Massachusetts, and Charles Lockwood, MD, Senior Vice President at the University of South Florida (USF) and Dean of the USF Health Morsani College of Medicine in Tampa came to the same conclusion: Elective induction of labor (eIOL) at 39 weeks is superior to expectant management when it comes to fetal outcomes.
In addition, they both agreed that complication rates to the mother (ie, number of cesarean deliveries [CDs]) would not be increased, and possibly even reduced, with eIOL at 39 weeks versus 41 weeks. Dr. Norwitz postulated that, with IOL there is no increase in CD rate in multiparous women and nulliparous women with a favorable cervical exam but that there likely could be an increase in the CD rate for nulliparous women with an unfavorable cervical exam.
The finding that eIOL at 39 weeks is better than at 41 weeks for the infant is likely due to a bigger baby size past 39 weeks (with more traumatic deliveries) and higher rates of postmaturity complications, said Dr. Lockwood. And for the mother, eIOL at 39 weeks can reduce risks—of preeclampsia, abruption, sepsis, and others—the presenters pointed out.
Arriving at their conclusions: The dataDr. Norwitz explained the challenge before them in this unusual “debate.” “In ObGyn we all read the same literature but we often come away with very different takes as to what the implications are and how we incorporate this into our management algorithms. Instead of taking a pro/con approach, with one assigned to ‘yes’ and the other assigned to ‘no,’ and selectively picking out the literature to support our positions, what we did was we each went away, read the literature, synthesized it, and tried to answer this question for ourselves.”
Dr. Norwitz, who is widely published and known for his research on the causes and prevention of preeclampsia and preterm labor, examined and presented the published literature for benefit and harms to the fetus and mother in continuing pregnancy past 39 weeks.
Dr. Lockwood also examined the literature, including a large population cohort of about 1.27 million women that examined CD rates, perinatal mortality, and neonatal and maternal outcomes of eIOL at 39 weeks versus expectant management.1 He presented, however, that the best evidence to compare the question at hand would be a randomized clinical trial comparing specifically eIOL at 39 weeks versus expectant management, with IOL at 41 weeks. To be powered to detect a difference in perinatal and maternal mortality, this trial would need to include 2.2 to 12.6 million women, he maintained. “When empirical evidence doesn’t exist, the only alternative is some kind of other modeling,” he said. Therefore, he and a team of researchers conducted a Monte Carlo microsimulation modeling decision analysis, taking into account “all outcomes and all preferences that we possibly could cull from the literature.”
Which women actually could benefit from eIOL at 39 weeks?Women with high-risk pregnancies were not included in this debate or considered. Dr. Norwitz clearly defined his case patient at the outset as a 22-year-old G1 at 39 0/7 weeks who has had an uncomplicated pregnancy but is now complaining of decreased fetal movement and tells you that she is worried because her sister lost her baby at 40 weeks to stillbirth. She specifically asks, “Doctor, why can’t you induce my labor now?”
What counseling a patient about the risks/benefits of eIOL at 39 weeks would requireTwo fundamentals would need to be ensured. The first: precise gestational dating. Dr. Norwitz pointed out that menstrual history can be inaccurate, especially in women with irregular cycles, who are taking hormonal contraception, or who have intermenstrual bleeding. “Early dating ultrasound is the best way to date pregnancies and probably should be done routinely,” although it is not currently standard of care in the United States, he said.
The second fundamental: a true induction of labor process, not one that involves “stopping at 5 PM,” said Dr. Lockwood.
“Although Dr. Lockwood’s 5-PM statement was made tongue-in-cheek,” said Dr. Norwitz after the debate, “he certainly was implying that a genuine effort should be made to effect a vaginal delivery—that is, giving the most effective cervical ripening agents, allowing enough time to pass, and defining clearly the criteria for failed IOL. You shouldn’t just throw the towel in at 5 PM because you want to go home.”
Cost implicationsElectively inducing labor in all women with low-risk pregnancies at 39 weeks is a strategy with unknown cost implications, and the cost difference between this strategy and expectant management up to 41 weeks is not known.
“We need to be sure that we understand the cost implications of these strategies, which of course would need to be balanced against the potential perinatal and maternal morbidity and fetal death,” said Dr. Lockwood.
The meaning of “elective”Dr. Norwitz also made the point postdebate that the American College of Obstetricians and Gynecologists (ACOG) does not support elective IOL prior to 39 weeks’ gestation. “The key term here is ‘elective,’" he said, "which refers to a delivery without a clear medical or obstetric indication. ACOG does support delivery prior to 39 weeks’ gestation, there just needs to be an appropriate indication.”
1. Stock SJ, Ferguson E, Duffy A, Ford I, Chalmers J, Norman JE. Outcomes of elective induction of labour compared with expectant management: population based study. BMJ. 2012;344:e2838.
1. Stock SJ, Ferguson E, Duffy A, Ford I, Chalmers J, Norman JE. Outcomes of elective induction of labour compared with expectant management: population based study. BMJ. 2012;344:e2838.
What insect repellents are safe during pregnancy?
With summer almost upon us, and the weather warming in many parts of the country, we have received questions from colleagues about the best over-the-counter insect repellants to advise their pregnant patients to use.
The preferred insect repellent for skin coverate is DEET (N,N-diethyl-meta-toluamide) (TABLE). Oil of lemon/eucalyptus/para-menthane-diol and IR3535 are also acceptable repellents to use on the skin that are safe for use in pregnancy. In addition, patients should be instructed to spray permethrin on their clothing or buy clothing (boots, pants, socks) that has been pretreated with permethrin.1,2
Repellent | Product | Manufacturer | Notes |
DEET (N,N-diethyl-meta-toluamide)
| Off! | SC Johnson | Preferred repellent for use on the skin |
Repel 100 | Spectrum Brands | ||
Ultra 30 Liposome Controlled Release | Sawyer | ||
Oil of lemon/eucalyptus/ para-menthane-diol | Repel Lemon Eucalyptus Insect Repellent | Spectrum Brands | Acceptable option for skin use |
IR3535 | Skin So Soft Bug Guard Plus IR3535 Expedition | Avon | Acceptable option for skin use |
Permethrin | Repel Permethrin Clothing & Gear Aerosol | Spectrum Brands | For use on clothing |
Permethrin Pump Spray | Sawyer | ||
Abbreviations: OTC, over the counter |
Share your thoughts on this article! Send your Letter to the Editor to rbarbieri@frontlinemedcom.com. Please include your name and the city and state in which you practice.
- Peterson EE, Staples JE, Meaney-Delman D, et al. Interim guidelines for pregnant women during a Zika virus outbreak – United States, 2016. MMWR Morb Mortal Wkly Rep. 2016;65(2):30-33.
- Centers for Disease Control and Prevention. CDC Features: Avoid mosquito bites. http://www.cdc.gov/Features/stopmosquitoes/index.html. Updated March 18, 2016. Accessed May 10, 2016.
With summer almost upon us, and the weather warming in many parts of the country, we have received questions from colleagues about the best over-the-counter insect repellants to advise their pregnant patients to use.
The preferred insect repellent for skin coverate is DEET (N,N-diethyl-meta-toluamide) (TABLE). Oil of lemon/eucalyptus/para-menthane-diol and IR3535 are also acceptable repellents to use on the skin that are safe for use in pregnancy. In addition, patients should be instructed to spray permethrin on their clothing or buy clothing (boots, pants, socks) that has been pretreated with permethrin.1,2
Repellent | Product | Manufacturer | Notes |
DEET (N,N-diethyl-meta-toluamide)
| Off! | SC Johnson | Preferred repellent for use on the skin |
Repel 100 | Spectrum Brands | ||
Ultra 30 Liposome Controlled Release | Sawyer | ||
Oil of lemon/eucalyptus/ para-menthane-diol | Repel Lemon Eucalyptus Insect Repellent | Spectrum Brands | Acceptable option for skin use |
IR3535 | Skin So Soft Bug Guard Plus IR3535 Expedition | Avon | Acceptable option for skin use |
Permethrin | Repel Permethrin Clothing & Gear Aerosol | Spectrum Brands | For use on clothing |
Permethrin Pump Spray | Sawyer | ||
Abbreviations: OTC, over the counter |
Share your thoughts on this article! Send your Letter to the Editor to rbarbieri@frontlinemedcom.com. Please include your name and the city and state in which you practice.
With summer almost upon us, and the weather warming in many parts of the country, we have received questions from colleagues about the best over-the-counter insect repellants to advise their pregnant patients to use.
The preferred insect repellent for skin coverate is DEET (N,N-diethyl-meta-toluamide) (TABLE). Oil of lemon/eucalyptus/para-menthane-diol and IR3535 are also acceptable repellents to use on the skin that are safe for use in pregnancy. In addition, patients should be instructed to spray permethrin on their clothing or buy clothing (boots, pants, socks) that has been pretreated with permethrin.1,2
Repellent | Product | Manufacturer | Notes |
DEET (N,N-diethyl-meta-toluamide)
| Off! | SC Johnson | Preferred repellent for use on the skin |
Repel 100 | Spectrum Brands | ||
Ultra 30 Liposome Controlled Release | Sawyer | ||
Oil of lemon/eucalyptus/ para-menthane-diol | Repel Lemon Eucalyptus Insect Repellent | Spectrum Brands | Acceptable option for skin use |
IR3535 | Skin So Soft Bug Guard Plus IR3535 Expedition | Avon | Acceptable option for skin use |
Permethrin | Repel Permethrin Clothing & Gear Aerosol | Spectrum Brands | For use on clothing |
Permethrin Pump Spray | Sawyer | ||
Abbreviations: OTC, over the counter |
Share your thoughts on this article! Send your Letter to the Editor to rbarbieri@frontlinemedcom.com. Please include your name and the city and state in which you practice.
- Peterson EE, Staples JE, Meaney-Delman D, et al. Interim guidelines for pregnant women during a Zika virus outbreak – United States, 2016. MMWR Morb Mortal Wkly Rep. 2016;65(2):30-33.
- Centers for Disease Control and Prevention. CDC Features: Avoid mosquito bites. http://www.cdc.gov/Features/stopmosquitoes/index.html. Updated March 18, 2016. Accessed May 10, 2016.
- Peterson EE, Staples JE, Meaney-Delman D, et al. Interim guidelines for pregnant women during a Zika virus outbreak – United States, 2016. MMWR Morb Mortal Wkly Rep. 2016;65(2):30-33.
- Centers for Disease Control and Prevention. CDC Features: Avoid mosquito bites. http://www.cdc.gov/Features/stopmosquitoes/index.html. Updated March 18, 2016. Accessed May 10, 2016.
How to help your patients control gestational weight gain
Resource:
Choosemyplate.org
Resource:
Choosemyplate.org
Resource:
Choosemyplate.org
Do patients have a gender preference for their ObGyn?
Although multiple surveys have been published regarding patient gender preference when choosing an ObGyn, overall results have not been analyzed. To address this literature gap, Kyle J. Tobler, MD, and colleagues at the Womack Army Medical Center in Fort Bragg, North Carolina, and Uniformed Services University of the Health Sciences in Bethesda, Maryland, searched multiple sources to provide a conglomerate analysis of patients’ gender preference when choosing an ObGyn. An abstract describing their study was published in Obstetrics & Gynecology in May 2016 and presented at the American College of Obstetricians and Gynecologists 2016 Annual Clinical and Scientific Meeting May 14−17, in Washington, DC.
A personal impetus for studying gender preference
The impetus for this project truly was initiated for Dr. Tobler when he was a 4th-year medical student. “I was trying to decide if Obstetrics and Gynecology was the right field for me,” he said. “I was discouraged by many people around me, who told me that men in ObGyn would not have a place, as female patients only wanted female ObGyns. And with the residency match at 60% to 70% women for ObGyn, it did seem that men would not have a place. Thus, I began searching the literature to verify if the question for gender preference for their ObGyn provider had been evaluated previously, and I found mixed results.” After medical school Dr. Tobler pursued this current meta-analysis to address the conflicting results.
Details of the study
Dr. Tobler and his colleagues explored PubMed, Embase, PsycINFO (American Psychological Association’s medical literature database), Cumulative Index to Nursing and Allied Health Literature (EBSCO Health’s database), Scopus (Elsevier’s abstract and citation database of peer-reviewed literature), and references of relevant articles. Included were 4,822 electronically-identified citations of English-language studies, including surveys administered to patients that specifically asked for gender preference of their ObGyn provider.
The researchers found that 23 studies met their inclusion criteria, comprising 14,736 patients. Overall, 8.3% (95% confidence interval [CI], 0.08-0.09) of ObGyn patients reported a preference for a male provider, 50.2% (95% CI, 0.49-0.51) preferred a female provider, and 41.3% (95% CI, 0.40-0.42) reported no gender preference when choosing an ObGyn.
What about US patients?
A subanalysis of studies (n = 9,861) conducted in the United States from 1999 to 2008 (with the last search undertaken in April 2015) showed that 8.4% (95% CI, 0.08-0.09) preferred a male ObGyn, 53.2% (95% CI, 0.52-0.54) preferred a female ObGyn, and 38.5% (95% CI, 0.38-0.39) had no gender preference.
“We were surprised by the numbers,” comments Dr. Tobler. “The general trend demonstrated a mix between no preference or a preference for female providers, but not by a large margin.”
“We considered analyzing for age,” he said, “but most of the studies gave a mean or median age value and were widely distributed. We were able, however, to break our analysis down into regions where one would expect a very strong preference for female providers—the Middle East and Africa. But in fact results were not much different than for Western countries. Our results for this subanalysis of Middle Eastern countries and Nigeria (n = 1,951) demonstrated that 8.7% of women (95% CI, 4.1-13.3) preferred a male provider, 51.2% (95% CI, 17.2-85.1) preferred a female provider, and 46.9% (95% CI, 9.3-84.5) had no gender preference.”
Updated May 20, 2016.
Reference
- Tobler KJ, Wu J, Khafagy AM, et al. Gender preference of the obstetrician gynecologist provider: a systematic review and meta-analysis. Obstet Gynecol. 2016;127(5)(suppl):43S. http://journals.lww.com/greenjournal/page/results.aspx?txtkeywords=Gender+preference+of+the+obstetrician+gynecologist+provider.Accessed May 18, 2016.
Although multiple surveys have been published regarding patient gender preference when choosing an ObGyn, overall results have not been analyzed. To address this literature gap, Kyle J. Tobler, MD, and colleagues at the Womack Army Medical Center in Fort Bragg, North Carolina, and Uniformed Services University of the Health Sciences in Bethesda, Maryland, searched multiple sources to provide a conglomerate analysis of patients’ gender preference when choosing an ObGyn. An abstract describing their study was published in Obstetrics & Gynecology in May 2016 and presented at the American College of Obstetricians and Gynecologists 2016 Annual Clinical and Scientific Meeting May 14−17, in Washington, DC.
A personal impetus for studying gender preference
The impetus for this project truly was initiated for Dr. Tobler when he was a 4th-year medical student. “I was trying to decide if Obstetrics and Gynecology was the right field for me,” he said. “I was discouraged by many people around me, who told me that men in ObGyn would not have a place, as female patients only wanted female ObGyns. And with the residency match at 60% to 70% women for ObGyn, it did seem that men would not have a place. Thus, I began searching the literature to verify if the question for gender preference for their ObGyn provider had been evaluated previously, and I found mixed results.” After medical school Dr. Tobler pursued this current meta-analysis to address the conflicting results.
Details of the study
Dr. Tobler and his colleagues explored PubMed, Embase, PsycINFO (American Psychological Association’s medical literature database), Cumulative Index to Nursing and Allied Health Literature (EBSCO Health’s database), Scopus (Elsevier’s abstract and citation database of peer-reviewed literature), and references of relevant articles. Included were 4,822 electronically-identified citations of English-language studies, including surveys administered to patients that specifically asked for gender preference of their ObGyn provider.
The researchers found that 23 studies met their inclusion criteria, comprising 14,736 patients. Overall, 8.3% (95% confidence interval [CI], 0.08-0.09) of ObGyn patients reported a preference for a male provider, 50.2% (95% CI, 0.49-0.51) preferred a female provider, and 41.3% (95% CI, 0.40-0.42) reported no gender preference when choosing an ObGyn.
What about US patients?
A subanalysis of studies (n = 9,861) conducted in the United States from 1999 to 2008 (with the last search undertaken in April 2015) showed that 8.4% (95% CI, 0.08-0.09) preferred a male ObGyn, 53.2% (95% CI, 0.52-0.54) preferred a female ObGyn, and 38.5% (95% CI, 0.38-0.39) had no gender preference.
“We were surprised by the numbers,” comments Dr. Tobler. “The general trend demonstrated a mix between no preference or a preference for female providers, but not by a large margin.”
“We considered analyzing for age,” he said, “but most of the studies gave a mean or median age value and were widely distributed. We were able, however, to break our analysis down into regions where one would expect a very strong preference for female providers—the Middle East and Africa. But in fact results were not much different than for Western countries. Our results for this subanalysis of Middle Eastern countries and Nigeria (n = 1,951) demonstrated that 8.7% of women (95% CI, 4.1-13.3) preferred a male provider, 51.2% (95% CI, 17.2-85.1) preferred a female provider, and 46.9% (95% CI, 9.3-84.5) had no gender preference.”
Updated May 20, 2016.
Although multiple surveys have been published regarding patient gender preference when choosing an ObGyn, overall results have not been analyzed. To address this literature gap, Kyle J. Tobler, MD, and colleagues at the Womack Army Medical Center in Fort Bragg, North Carolina, and Uniformed Services University of the Health Sciences in Bethesda, Maryland, searched multiple sources to provide a conglomerate analysis of patients’ gender preference when choosing an ObGyn. An abstract describing their study was published in Obstetrics & Gynecology in May 2016 and presented at the American College of Obstetricians and Gynecologists 2016 Annual Clinical and Scientific Meeting May 14−17, in Washington, DC.
A personal impetus for studying gender preference
The impetus for this project truly was initiated for Dr. Tobler when he was a 4th-year medical student. “I was trying to decide if Obstetrics and Gynecology was the right field for me,” he said. “I was discouraged by many people around me, who told me that men in ObGyn would not have a place, as female patients only wanted female ObGyns. And with the residency match at 60% to 70% women for ObGyn, it did seem that men would not have a place. Thus, I began searching the literature to verify if the question for gender preference for their ObGyn provider had been evaluated previously, and I found mixed results.” After medical school Dr. Tobler pursued this current meta-analysis to address the conflicting results.
Details of the study
Dr. Tobler and his colleagues explored PubMed, Embase, PsycINFO (American Psychological Association’s medical literature database), Cumulative Index to Nursing and Allied Health Literature (EBSCO Health’s database), Scopus (Elsevier’s abstract and citation database of peer-reviewed literature), and references of relevant articles. Included were 4,822 electronically-identified citations of English-language studies, including surveys administered to patients that specifically asked for gender preference of their ObGyn provider.
The researchers found that 23 studies met their inclusion criteria, comprising 14,736 patients. Overall, 8.3% (95% confidence interval [CI], 0.08-0.09) of ObGyn patients reported a preference for a male provider, 50.2% (95% CI, 0.49-0.51) preferred a female provider, and 41.3% (95% CI, 0.40-0.42) reported no gender preference when choosing an ObGyn.
What about US patients?
A subanalysis of studies (n = 9,861) conducted in the United States from 1999 to 2008 (with the last search undertaken in April 2015) showed that 8.4% (95% CI, 0.08-0.09) preferred a male ObGyn, 53.2% (95% CI, 0.52-0.54) preferred a female ObGyn, and 38.5% (95% CI, 0.38-0.39) had no gender preference.
“We were surprised by the numbers,” comments Dr. Tobler. “The general trend demonstrated a mix between no preference or a preference for female providers, but not by a large margin.”
“We considered analyzing for age,” he said, “but most of the studies gave a mean or median age value and were widely distributed. We were able, however, to break our analysis down into regions where one would expect a very strong preference for female providers—the Middle East and Africa. But in fact results were not much different than for Western countries. Our results for this subanalysis of Middle Eastern countries and Nigeria (n = 1,951) demonstrated that 8.7% of women (95% CI, 4.1-13.3) preferred a male provider, 51.2% (95% CI, 17.2-85.1) preferred a female provider, and 46.9% (95% CI, 9.3-84.5) had no gender preference.”
Updated May 20, 2016.
Reference
- Tobler KJ, Wu J, Khafagy AM, et al. Gender preference of the obstetrician gynecologist provider: a systematic review and meta-analysis. Obstet Gynecol. 2016;127(5)(suppl):43S. http://journals.lww.com/greenjournal/page/results.aspx?txtkeywords=Gender+preference+of+the+obstetrician+gynecologist+provider.Accessed May 18, 2016.
Reference
- Tobler KJ, Wu J, Khafagy AM, et al. Gender preference of the obstetrician gynecologist provider: a systematic review and meta-analysis. Obstet Gynecol. 2016;127(5)(suppl):43S. http://journals.lww.com/greenjournal/page/results.aspx?txtkeywords=Gender+preference+of+the+obstetrician+gynecologist+provider.Accessed May 18, 2016.
2016 Update on cervical disease
For the past 40 to 50 years, the first-line treatment for high-grade cervical intraepithelial neoplasia (CIN) has been excisional procedures (including loop electrosurgical excision [LEEP], cone biopsy, cryosurgery, and laser therapy), and these treatments work well. It appears, however, that these procedures potentially can lead to preterm birth.1–3 With results from large, comprehensive meta-analyses that control for such risk factors as smoking and other factors that could contribute to both preterm birth and high-grade CIN, we have learned that excision treatment can result in a 2% to 5% increased risk for preterm birth, depending on the size and the extent of excision performed.1–3 The preterm birth rate in the United States is about 11.4%.4 With about 500,000 excisional treatments for high-grade CIN performed in the United States every year, and about 2% of preterm births caused by excisional procedures, conservatively, about 5,000 to 10,000 US preterm births are directly related to excisional procedures for high-grade CIN annually.
Clearly, excisional treatment for high-grade CIN and its connection to preterm birth adds to health care costs and long-term morbidity because babies that are born preterm potentially have diminished functionality. We need a better treatment approach other than excision to CIN, which is known to be a virally mediated disease. Consider the fact that just because excisional procedures remove potentially cancerous cells does not mean that these treatments remove the underlying reason behind the high-grade CIN—HPV. We cannot cut out a virus. Consequently, many studies have explored better-targeted therapies against high-grade CIN. Immune-based therapies, which can train a patient’s own immune system to attack HPV-infected cells, are exciting possibilities.
In this Update, I focus on 2 studies of immune-based therapies to treat cervical cancer. In addition, I discuss long-term follow-up data that are available regarding efficacy of primary HPV testing.
HPV therapeutic vaccine shows promise in RCT
Trimble CL, Morrow MP, Kraynyak KA, et al. Safety, efficacy, and immunogenicity of VGX-3100, a therapeutic synthetic DNA vaccine targeting human papillomavirus 16 and 18 E6 and E7 proteins for cervical intraepithelial neoplasia 2/3: a randomised, double-blind, placebo-controlled phase 2b trial. Lancet. 2015;386(10008):2078-2088.
While the promise of immune-based therapies to target a virally mediated disease has good scientific rationale, there have been many generally negative studies published in the past 15 years on immune-based targeted therapies. This study by Trimble and colleagues has interesting results because it is a randomized controlled trial (RCT) using a DNA vaccine delivered with a novel approach called electroporation. Electroporation generates a small electrical shot at the vaccine site that potentially increases a vaccine's DNA uptake and the patient's immune response.
Details of the study
Women aged 18 to 55 years with HPV16- or HPV18-positive high-grade CIN from 36 academic and private gynecology practices in 7 countries were assigned in a 3:1 blinded randomization to receive vaccine (6 mg; VGX-3100) or placebo (1 mL), given intramuscularly at 0, 4, and 12 weeks. Patients were stratified by age 25 or older versus younger than 25 and by CIN2 versus CIN3. The primary efficacy endpoint was regression to CIN1 or normal pathology 36 weeks after the first vaccine dose.
A mandatory interim safety colposcopy was performed 12 weeks after the third vaccine dose. At 36 weeks (the primary endpoint visit), patients with colposcopic evidence of residual disease underwent standard excision (LEEP or cone). In patients with no evidence of disease, investigators could biopsy the site of the original lesions. At 40 weeks, when all patients had completed their first visit after the primary endpoint, the data were unmasked. Long-term follow-up data were collected on all patients with remaining visits. Patients and study site investigators and personnel stayed masked to treatment until study data were final.
Results indicated a significant clinical response as well as an immune response in those patients who were treated with electroporation and the vaccine versus electroporation and placebo. In the per-protocol analysis, 53 (49.5%) of 107 vaccine recipients and 11 (30.6%) of 36 placebo recipients had histopathologic regression (percentage point difference [PPD], 19.0 [95% confidence interval CI, 1.4-36.6]; P = .034) (FIGURE 1). In the modified intention-to-treat analysis, 55 (48.2%) of 114 vaccine recipients and 12 (30.0%) of 40 placebo recipients had histopathologic regression (PPD, 18.2; 95% CI, 1.3-34.4; P = .034).
Injection-site reactions occurred in most patients, but only erythema was significantly more common in the vaccine group than in the placebo group (PPD, 21.3 [95% CI, 5.3-37.8]; P = .007).
What this evidence means for practice
In prior studies of immunotherapies, there have not been good correlations between immune responses and clinical responses, and this is one of the important differences between this study by Trimble and colleagues and prior studies in this space. Unfortunately, immune-based therapies are a "shot in the dark," with researchers not knowing which patients may have an increased immune response but no clinical response or a clinical response but no immune response. The measured immune responses are from peripheral blood, an immune response that might not reflect the milieu of immune responses in the cervical-vaginal tract.
If perfected, technologies like these hold the promise of minimizing the amount of patients who need to undergo excisional procedures because patients' own immune systems have been trained to target HPV-infected cells. The bigger hope is that we will be able to minimize preterm births that are directly related to treatment of dysplasia.
Adoptive T-cell therapy offers targeted treatment for recurrent cervical cancer
Stevanovic S, Draper LM, Langhan MM, et al. Complete regression of metastatic cervical cancer after treatment with human papillomavirus-targeted tumor-infiltrating T cells. J Clin Oncol. 2015;33(14):1543-1550.
Stevanovic and colleagues have been developing another immune-based therapy that has been tested for other cancers. This uses a method for generating T-cell cultures from HPV-positive cancers and selecting specific HPV oncoprotein- reactive cultures for administration to patients. Termed adoptive T-cell therapy (ACT), this targeted approach to recurrent cervical cancer is what I would consider one of the most intriguing future treatments of cervical disease. In the past, the largest barrier to an effective HPV vaccine to treat cervical cancer has been lack of clinical response to existing cytotoxic regimens. In this, albeit small, trial, investigators found a correlation between HPV reactivity and the infused T cells and objective clinical responses.
What is adoptive T-cell therapy?
ACT allows for more rigorous control over the magnitude of the targeted response than tumor vaccination treatment strategies because the T cells used for therapy are identified and selected in vitro. The cells selected are exposed to cytokines and immunomodulators that influence differentiation during priming and are expanded to large numbers. The resulting number of antigen-specific T cells produced in the peripheral blood is much greater (more than 10-fold) than that possible by current vaccine regimens alone.
Studies conducted by the National Cancer Institute of adoptive transfer of in vitro-selected tumor-infiltrating lymphocytes were the first to demonstrate the potential of T-cell immunotherapy to eradicate solid tumors.5,6 Among 13 patients with melanoma, treatment with adoptive transfer of ex vivo-amplified autologous tumor-infiltrating T cells resulted in treatment response in 10 of the patients—clinical responses in 6 and mixed responses in 4.
Details of the study
This study by Stevanovic and colleagues involved 9 patients with metastatic cervical cancer who previously had received optimal recommended chemotherapy or concomitant chemoradiotherapy regimens. Patients were treated with a single infusion of tumor-infiltrating T cells specifically selected for HPV E6 and E7 reactivity (HPV-TILs). Patients received lymphocyte-depleting chemotherapy before ACT and aldesleukin chemotherapy injection after ACT.
In such a phase I population, one would not expect clinical responses over persistent stable disease. However, in this small trial, 2 patients had complete tumor regression and 1 patient had a partial treatment response, demonstrating that a complete response to metastatic cervical cancer can occur after a single infusion of HPV-TILs. The partial response lasted 3 months. The 2 complete responses were ongoing 22 and 15 months after treatment (FIGURE 2).
Editorialists point out that, only when the infusion product had reactivity against the HPV E6 and E7 peptides did the patients show objective clinical response, suggesting it was the immune response that contributed to the tumor regression.7 In addition, in the 3 patients with objective responses, HPV-specific T cells persisted in peripheral blood for several months.
FIGURE 2 Patients with complete tumor responses with adoptive T-cell therapy | ||
Two patients with metastatic cervical cancer had complete tumor responses with treatment with tumor-infiltrating T cells selected for HPV E6 and E7 reactivity (HPV-TILs). Contrast-enhanced computed tomography scans obtained before treatment and at most recent follow-up for both patients. (A) First patient (patient 3) had disease involving para-aortic, bilateral hilar, subcarinal, and left iliac lymph nodes (gold arrows). Patient had no evidence of disease 22 months after treatment. (B) Second patient (patient 6) had metastatic disease in para-aortic lymph node, abdominal wall, aortocaval lymph node, left pericolic pelvic mass, and right ureteral nodule (gold arrows). Patient had no evidence of disease 15 months after treatment. (Red arrowhead indicates ureteral stent that was removed after right ureteral tumor regressed.) |
Stevanovic S, Draper LM, Langhan MM, et al. Complete regression of metastatic cervical cancer after treatment with human papillomavirus-targeted tumor-infiltrating T cells.J Clin Oncol. 2015;33(14):1543–1550. Used with permission.
What this evidence means for practice
The recent approval of bevacizumab has been a major breakthrough in the treatment of advanced and recurrent cervical cancer. Although ACT is a treatment that is in early clinical development, it is the next major advance in this area. Its promise is currently limited, as the process is cumbersome and complex, involving surgical removal of a patient's lymph nodes, culturing of the T cells from the lymph nodes, and infusing the T cells with the oncoproteins that will train those T cells to infiltrate the cancer tumor. The process is wrought with potential problems in laboratory and translational techniques. However, this group of investigators from the NCI has perfected the process of ACT, creating T cells that will target the HPV that is integrated into each cervical cancer tumor.
The patients who demonstrated good T-cell reactivity against HPV were the ones who had a treatment response, which demonstrates the targeted precision of ACT therapy. There might come a day when we can select patients with recurrent cervical cancer who are going to have T-cell reactivity, and send them for treatment to a center specialized in ACT. Typically in phase 1 trials, we are happy to see a number of patients responding with stable disease. In this trial, 2 patients had a complete response. The results demonstrated by Stevanovic and colleagues are very exciting for the future treatment of patients with cervical cancer.
Primary HPV screening shows up to 70% greater protection against invasive cervical cancer than cytology
Ronco G, Dillner J, Elfstrom KM; International HPV Screening Working Group. Efficacy of HPV-based screening for prevention of invasive cervical cancer: follow-up of four European randomised controlled trials. Lancet. 2014;383(9916):424-532.
In my 2015 "Update on Cervical Disease,"8 I discussed the newly published interim guidance for managing abnormal screening results for cervical cancer from a collective expert panel from the American Society for Colposcopy and Cervical Pathology, Society of Gynecologic Oncology, the American College of Obstetricians and Gynecologists, and 4 more societies.9 The guidelines support use of HPV testing alone or with the Papanicolaou test. In 2016, follow-up data from 4 RCTs provide long-term data on the efficacy of HPV primary testing.
Details of the trial
Incidence of invasive cervical cancer was the endpoint in 4 European trials comparing HPV-based with cytology-based screening. In total, 176,464 women aged 20 to 64 years were randomly assigned to either screening strategy. Median follow-up was 6.5 years (1,214,415 person-years). Using screening, pathology, and cancer registries investigators identified 107 invasive cervical carcinomas, with masked review of histologic specimens and reports.
Investigators calculated the rate ratios (defined as the cancer detection rate in the primary HPV testing-based versus cytology-based arms) for incidence of invasive cervical cancer. During the first 2.5 years of follow-up, detection of invasive cancer was similar between screening methods (0.79, 0.46-1.36). Thereafter, however, cumulative cancer detection was lower in the primary HPV testing-based arm (0.45; 95% CI, 0.25-0.81).
At 3.5 and 5.5 years after a negative cytology test on entry, cumulative cancer incidence was 15.4 per 105 (95% CI, 7.9-27.0) and 36.0 per 105 (23.2-53.5), respectively. At 3.5 and 5.5 years after a negative HPV test on entry, cumulative cancer incidence was 4.6 per 105 (1.1-12.1) and 8.7 per 105 (3.3-18.6), respectively (FIGURE 3).
FIGURE 3 Cumulative detection of invasive cervical carcinoma | ||
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*Observations are censored 2.5 years after CIN2 or CIN3 detection, if any.
|
What this EVIDENCE means for practice
The 4 studies in this report were completed across Europe (in England, Netherlands, Sweden, and Italy): different regions, different sites, hospitals, and screening systems. The women in Europe are not any different than the women in the United States in terms of rates of HPV and age and incidence of HPV. Therefore, these results are globally generalizable.
The US trial by Wright and colleagues10 that led to US Food and Drug Administration approval of HPV primary testing was different than this European study in that all trial sites had to perform screening in the same way. In addition, the end point was high-grade dysplasia; in this trial by Ronco and colleagues the end point is cancer. These current investigators found no difference with either screening arm in terms of detection of invasive cervical cancer. Even more interesting is that, over time, the cervical cancer rates in the primary HPV testing-based arm were much less than that in the cytology-based arm.
The real strengths of this study are the long-term follow-up and the study size. We are not likely to see validation cohorts this big again. This study demonstrates that, overall, we should be able to continue to reduce the incidence of invasive cervical cancer with a primary HPV testing-based screening strategy.
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.
- Conner SN, Frey HA, Cahill AG, Macones GA, Colditz GA, Tuuli MG. Loop electrosurgical excision procedure and risk of preterm birth: a systematic review and meta-analysis. Obstet Gynecol. 2014;123(4):752−761.
- Kyrgiou M, Valasoulis G, Stasinou SM, et al. Proportion of cervical excision for cervical intraepithelial neoplasia as a predictor of pregnancy outcomes. Int J Gynaecol Obstet. 2015;128(2):141−147.
- Miller ES, Grobman WA. The association between cervical excisional procedures, midtrimester cervical length, and preterm birth. Am J Obstet Gynecol. 2014;211(3):242.e1−e4.
- Martin JA, Hamilton BE, Osterman MJ, Curtin SC, Mathews TJ. Births: Final data for 2013. Natl Vital Stat Rep. 2015;64(1):1–65. http://www.cdc.gov/nchs/data/nvsr/nvsr64/nvsr64_01.pdf. Published January 15, 2015. Accessed April 20, 2016.
- Dudley ME, Wunderlich JR, Robbins PF, et al. Cancer regression and autoimmunity in patients after clonal repopulation with antitumor lymphocytes. Science. 2002;298(5594):850–854.
- Dudley ME, Wunderlich JR, Yang JC, et al. Adoptive cell transfer therapy following non-myeloablative but lymphodepleting chemotherapy for the treatment of patients with refractory metastatic melanoma. J Clin Oncol. 2005;23(10):2346−2357.
- Zsiros E, Tsuli T, Odunsi K. Adoptive T-cell therapy is a promising salvage approach for advanced or recurrent metastatic cervical cancer. J Clin Oncol. 2015;33(14):1521−1522.
- Einstein MH. Update on cervical disease: New ammo for HPV prevention and screening. OBG Manag. 2015;27(5):32−39.
- Huh WK, Ault KA, Chelmow D, et al. Use of primary high-risk human papillomavirus testing for cervical cancer screening: interim clinical guidance. Gynecol Oncol. 2015;136(2):178–182.
- Wright TC, Stoler MH, Behrens CM, Sharma A, Zhang G, Wright TL. Primary cervical cancer screening with human papillomavirus: end of study results from the ATHENA study using HPV as the first-line screening test. Gynecol Oncol. 2015;136(2):189–197.
For the past 40 to 50 years, the first-line treatment for high-grade cervical intraepithelial neoplasia (CIN) has been excisional procedures (including loop electrosurgical excision [LEEP], cone biopsy, cryosurgery, and laser therapy), and these treatments work well. It appears, however, that these procedures potentially can lead to preterm birth.1–3 With results from large, comprehensive meta-analyses that control for such risk factors as smoking and other factors that could contribute to both preterm birth and high-grade CIN, we have learned that excision treatment can result in a 2% to 5% increased risk for preterm birth, depending on the size and the extent of excision performed.1–3 The preterm birth rate in the United States is about 11.4%.4 With about 500,000 excisional treatments for high-grade CIN performed in the United States every year, and about 2% of preterm births caused by excisional procedures, conservatively, about 5,000 to 10,000 US preterm births are directly related to excisional procedures for high-grade CIN annually.
Clearly, excisional treatment for high-grade CIN and its connection to preterm birth adds to health care costs and long-term morbidity because babies that are born preterm potentially have diminished functionality. We need a better treatment approach other than excision to CIN, which is known to be a virally mediated disease. Consider the fact that just because excisional procedures remove potentially cancerous cells does not mean that these treatments remove the underlying reason behind the high-grade CIN—HPV. We cannot cut out a virus. Consequently, many studies have explored better-targeted therapies against high-grade CIN. Immune-based therapies, which can train a patient’s own immune system to attack HPV-infected cells, are exciting possibilities.
In this Update, I focus on 2 studies of immune-based therapies to treat cervical cancer. In addition, I discuss long-term follow-up data that are available regarding efficacy of primary HPV testing.
HPV therapeutic vaccine shows promise in RCT
Trimble CL, Morrow MP, Kraynyak KA, et al. Safety, efficacy, and immunogenicity of VGX-3100, a therapeutic synthetic DNA vaccine targeting human papillomavirus 16 and 18 E6 and E7 proteins for cervical intraepithelial neoplasia 2/3: a randomised, double-blind, placebo-controlled phase 2b trial. Lancet. 2015;386(10008):2078-2088.
While the promise of immune-based therapies to target a virally mediated disease has good scientific rationale, there have been many generally negative studies published in the past 15 years on immune-based targeted therapies. This study by Trimble and colleagues has interesting results because it is a randomized controlled trial (RCT) using a DNA vaccine delivered with a novel approach called electroporation. Electroporation generates a small electrical shot at the vaccine site that potentially increases a vaccine's DNA uptake and the patient's immune response.
Details of the study
Women aged 18 to 55 years with HPV16- or HPV18-positive high-grade CIN from 36 academic and private gynecology practices in 7 countries were assigned in a 3:1 blinded randomization to receive vaccine (6 mg; VGX-3100) or placebo (1 mL), given intramuscularly at 0, 4, and 12 weeks. Patients were stratified by age 25 or older versus younger than 25 and by CIN2 versus CIN3. The primary efficacy endpoint was regression to CIN1 or normal pathology 36 weeks after the first vaccine dose.
A mandatory interim safety colposcopy was performed 12 weeks after the third vaccine dose. At 36 weeks (the primary endpoint visit), patients with colposcopic evidence of residual disease underwent standard excision (LEEP or cone). In patients with no evidence of disease, investigators could biopsy the site of the original lesions. At 40 weeks, when all patients had completed their first visit after the primary endpoint, the data were unmasked. Long-term follow-up data were collected on all patients with remaining visits. Patients and study site investigators and personnel stayed masked to treatment until study data were final.
Results indicated a significant clinical response as well as an immune response in those patients who were treated with electroporation and the vaccine versus electroporation and placebo. In the per-protocol analysis, 53 (49.5%) of 107 vaccine recipients and 11 (30.6%) of 36 placebo recipients had histopathologic regression (percentage point difference [PPD], 19.0 [95% confidence interval CI, 1.4-36.6]; P = .034) (FIGURE 1). In the modified intention-to-treat analysis, 55 (48.2%) of 114 vaccine recipients and 12 (30.0%) of 40 placebo recipients had histopathologic regression (PPD, 18.2; 95% CI, 1.3-34.4; P = .034).
Injection-site reactions occurred in most patients, but only erythema was significantly more common in the vaccine group than in the placebo group (PPD, 21.3 [95% CI, 5.3-37.8]; P = .007).
What this evidence means for practice
In prior studies of immunotherapies, there have not been good correlations between immune responses and clinical responses, and this is one of the important differences between this study by Trimble and colleagues and prior studies in this space. Unfortunately, immune-based therapies are a "shot in the dark," with researchers not knowing which patients may have an increased immune response but no clinical response or a clinical response but no immune response. The measured immune responses are from peripheral blood, an immune response that might not reflect the milieu of immune responses in the cervical-vaginal tract.
If perfected, technologies like these hold the promise of minimizing the amount of patients who need to undergo excisional procedures because patients' own immune systems have been trained to target HPV-infected cells. The bigger hope is that we will be able to minimize preterm births that are directly related to treatment of dysplasia.
Adoptive T-cell therapy offers targeted treatment for recurrent cervical cancer
Stevanovic S, Draper LM, Langhan MM, et al. Complete regression of metastatic cervical cancer after treatment with human papillomavirus-targeted tumor-infiltrating T cells. J Clin Oncol. 2015;33(14):1543-1550.
Stevanovic and colleagues have been developing another immune-based therapy that has been tested for other cancers. This uses a method for generating T-cell cultures from HPV-positive cancers and selecting specific HPV oncoprotein- reactive cultures for administration to patients. Termed adoptive T-cell therapy (ACT), this targeted approach to recurrent cervical cancer is what I would consider one of the most intriguing future treatments of cervical disease. In the past, the largest barrier to an effective HPV vaccine to treat cervical cancer has been lack of clinical response to existing cytotoxic regimens. In this, albeit small, trial, investigators found a correlation between HPV reactivity and the infused T cells and objective clinical responses.
What is adoptive T-cell therapy?
ACT allows for more rigorous control over the magnitude of the targeted response than tumor vaccination treatment strategies because the T cells used for therapy are identified and selected in vitro. The cells selected are exposed to cytokines and immunomodulators that influence differentiation during priming and are expanded to large numbers. The resulting number of antigen-specific T cells produced in the peripheral blood is much greater (more than 10-fold) than that possible by current vaccine regimens alone.
Studies conducted by the National Cancer Institute of adoptive transfer of in vitro-selected tumor-infiltrating lymphocytes were the first to demonstrate the potential of T-cell immunotherapy to eradicate solid tumors.5,6 Among 13 patients with melanoma, treatment with adoptive transfer of ex vivo-amplified autologous tumor-infiltrating T cells resulted in treatment response in 10 of the patients—clinical responses in 6 and mixed responses in 4.
Details of the study
This study by Stevanovic and colleagues involved 9 patients with metastatic cervical cancer who previously had received optimal recommended chemotherapy or concomitant chemoradiotherapy regimens. Patients were treated with a single infusion of tumor-infiltrating T cells specifically selected for HPV E6 and E7 reactivity (HPV-TILs). Patients received lymphocyte-depleting chemotherapy before ACT and aldesleukin chemotherapy injection after ACT.
In such a phase I population, one would not expect clinical responses over persistent stable disease. However, in this small trial, 2 patients had complete tumor regression and 1 patient had a partial treatment response, demonstrating that a complete response to metastatic cervical cancer can occur after a single infusion of HPV-TILs. The partial response lasted 3 months. The 2 complete responses were ongoing 22 and 15 months after treatment (FIGURE 2).
Editorialists point out that, only when the infusion product had reactivity against the HPV E6 and E7 peptides did the patients show objective clinical response, suggesting it was the immune response that contributed to the tumor regression.7 In addition, in the 3 patients with objective responses, HPV-specific T cells persisted in peripheral blood for several months.
FIGURE 2 Patients with complete tumor responses with adoptive T-cell therapy | ||
Two patients with metastatic cervical cancer had complete tumor responses with treatment with tumor-infiltrating T cells selected for HPV E6 and E7 reactivity (HPV-TILs). Contrast-enhanced computed tomography scans obtained before treatment and at most recent follow-up for both patients. (A) First patient (patient 3) had disease involving para-aortic, bilateral hilar, subcarinal, and left iliac lymph nodes (gold arrows). Patient had no evidence of disease 22 months after treatment. (B) Second patient (patient 6) had metastatic disease in para-aortic lymph node, abdominal wall, aortocaval lymph node, left pericolic pelvic mass, and right ureteral nodule (gold arrows). Patient had no evidence of disease 15 months after treatment. (Red arrowhead indicates ureteral stent that was removed after right ureteral tumor regressed.) |
Stevanovic S, Draper LM, Langhan MM, et al. Complete regression of metastatic cervical cancer after treatment with human papillomavirus-targeted tumor-infiltrating T cells.J Clin Oncol. 2015;33(14):1543–1550. Used with permission.
What this evidence means for practice
The recent approval of bevacizumab has been a major breakthrough in the treatment of advanced and recurrent cervical cancer. Although ACT is a treatment that is in early clinical development, it is the next major advance in this area. Its promise is currently limited, as the process is cumbersome and complex, involving surgical removal of a patient's lymph nodes, culturing of the T cells from the lymph nodes, and infusing the T cells with the oncoproteins that will train those T cells to infiltrate the cancer tumor. The process is wrought with potential problems in laboratory and translational techniques. However, this group of investigators from the NCI has perfected the process of ACT, creating T cells that will target the HPV that is integrated into each cervical cancer tumor.
The patients who demonstrated good T-cell reactivity against HPV were the ones who had a treatment response, which demonstrates the targeted precision of ACT therapy. There might come a day when we can select patients with recurrent cervical cancer who are going to have T-cell reactivity, and send them for treatment to a center specialized in ACT. Typically in phase 1 trials, we are happy to see a number of patients responding with stable disease. In this trial, 2 patients had a complete response. The results demonstrated by Stevanovic and colleagues are very exciting for the future treatment of patients with cervical cancer.
Primary HPV screening shows up to 70% greater protection against invasive cervical cancer than cytology
Ronco G, Dillner J, Elfstrom KM; International HPV Screening Working Group. Efficacy of HPV-based screening for prevention of invasive cervical cancer: follow-up of four European randomised controlled trials. Lancet. 2014;383(9916):424-532.
In my 2015 "Update on Cervical Disease,"8 I discussed the newly published interim guidance for managing abnormal screening results for cervical cancer from a collective expert panel from the American Society for Colposcopy and Cervical Pathology, Society of Gynecologic Oncology, the American College of Obstetricians and Gynecologists, and 4 more societies.9 The guidelines support use of HPV testing alone or with the Papanicolaou test. In 2016, follow-up data from 4 RCTs provide long-term data on the efficacy of HPV primary testing.
Details of the trial
Incidence of invasive cervical cancer was the endpoint in 4 European trials comparing HPV-based with cytology-based screening. In total, 176,464 women aged 20 to 64 years were randomly assigned to either screening strategy. Median follow-up was 6.5 years (1,214,415 person-years). Using screening, pathology, and cancer registries investigators identified 107 invasive cervical carcinomas, with masked review of histologic specimens and reports.
Investigators calculated the rate ratios (defined as the cancer detection rate in the primary HPV testing-based versus cytology-based arms) for incidence of invasive cervical cancer. During the first 2.5 years of follow-up, detection of invasive cancer was similar between screening methods (0.79, 0.46-1.36). Thereafter, however, cumulative cancer detection was lower in the primary HPV testing-based arm (0.45; 95% CI, 0.25-0.81).
At 3.5 and 5.5 years after a negative cytology test on entry, cumulative cancer incidence was 15.4 per 105 (95% CI, 7.9-27.0) and 36.0 per 105 (23.2-53.5), respectively. At 3.5 and 5.5 years after a negative HPV test on entry, cumulative cancer incidence was 4.6 per 105 (1.1-12.1) and 8.7 per 105 (3.3-18.6), respectively (FIGURE 3).
FIGURE 3 Cumulative detection of invasive cervical carcinoma | ||
![]() | ||
*Observations are censored 2.5 years after CIN2 or CIN3 detection, if any.
|
What this EVIDENCE means for practice
The 4 studies in this report were completed across Europe (in England, Netherlands, Sweden, and Italy): different regions, different sites, hospitals, and screening systems. The women in Europe are not any different than the women in the United States in terms of rates of HPV and age and incidence of HPV. Therefore, these results are globally generalizable.
The US trial by Wright and colleagues10 that led to US Food and Drug Administration approval of HPV primary testing was different than this European study in that all trial sites had to perform screening in the same way. In addition, the end point was high-grade dysplasia; in this trial by Ronco and colleagues the end point is cancer. These current investigators found no difference with either screening arm in terms of detection of invasive cervical cancer. Even more interesting is that, over time, the cervical cancer rates in the primary HPV testing-based arm were much less than that in the cytology-based arm.
The real strengths of this study are the long-term follow-up and the study size. We are not likely to see validation cohorts this big again. This study demonstrates that, overall, we should be able to continue to reduce the incidence of invasive cervical cancer with a primary HPV testing-based screening strategy.
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.
For the past 40 to 50 years, the first-line treatment for high-grade cervical intraepithelial neoplasia (CIN) has been excisional procedures (including loop electrosurgical excision [LEEP], cone biopsy, cryosurgery, and laser therapy), and these treatments work well. It appears, however, that these procedures potentially can lead to preterm birth.1–3 With results from large, comprehensive meta-analyses that control for such risk factors as smoking and other factors that could contribute to both preterm birth and high-grade CIN, we have learned that excision treatment can result in a 2% to 5% increased risk for preterm birth, depending on the size and the extent of excision performed.1–3 The preterm birth rate in the United States is about 11.4%.4 With about 500,000 excisional treatments for high-grade CIN performed in the United States every year, and about 2% of preterm births caused by excisional procedures, conservatively, about 5,000 to 10,000 US preterm births are directly related to excisional procedures for high-grade CIN annually.
Clearly, excisional treatment for high-grade CIN and its connection to preterm birth adds to health care costs and long-term morbidity because babies that are born preterm potentially have diminished functionality. We need a better treatment approach other than excision to CIN, which is known to be a virally mediated disease. Consider the fact that just because excisional procedures remove potentially cancerous cells does not mean that these treatments remove the underlying reason behind the high-grade CIN—HPV. We cannot cut out a virus. Consequently, many studies have explored better-targeted therapies against high-grade CIN. Immune-based therapies, which can train a patient’s own immune system to attack HPV-infected cells, are exciting possibilities.
In this Update, I focus on 2 studies of immune-based therapies to treat cervical cancer. In addition, I discuss long-term follow-up data that are available regarding efficacy of primary HPV testing.
HPV therapeutic vaccine shows promise in RCT
Trimble CL, Morrow MP, Kraynyak KA, et al. Safety, efficacy, and immunogenicity of VGX-3100, a therapeutic synthetic DNA vaccine targeting human papillomavirus 16 and 18 E6 and E7 proteins for cervical intraepithelial neoplasia 2/3: a randomised, double-blind, placebo-controlled phase 2b trial. Lancet. 2015;386(10008):2078-2088.
While the promise of immune-based therapies to target a virally mediated disease has good scientific rationale, there have been many generally negative studies published in the past 15 years on immune-based targeted therapies. This study by Trimble and colleagues has interesting results because it is a randomized controlled trial (RCT) using a DNA vaccine delivered with a novel approach called electroporation. Electroporation generates a small electrical shot at the vaccine site that potentially increases a vaccine's DNA uptake and the patient's immune response.
Details of the study
Women aged 18 to 55 years with HPV16- or HPV18-positive high-grade CIN from 36 academic and private gynecology practices in 7 countries were assigned in a 3:1 blinded randomization to receive vaccine (6 mg; VGX-3100) or placebo (1 mL), given intramuscularly at 0, 4, and 12 weeks. Patients were stratified by age 25 or older versus younger than 25 and by CIN2 versus CIN3. The primary efficacy endpoint was regression to CIN1 or normal pathology 36 weeks after the first vaccine dose.
A mandatory interim safety colposcopy was performed 12 weeks after the third vaccine dose. At 36 weeks (the primary endpoint visit), patients with colposcopic evidence of residual disease underwent standard excision (LEEP or cone). In patients with no evidence of disease, investigators could biopsy the site of the original lesions. At 40 weeks, when all patients had completed their first visit after the primary endpoint, the data were unmasked. Long-term follow-up data were collected on all patients with remaining visits. Patients and study site investigators and personnel stayed masked to treatment until study data were final.
Results indicated a significant clinical response as well as an immune response in those patients who were treated with electroporation and the vaccine versus electroporation and placebo. In the per-protocol analysis, 53 (49.5%) of 107 vaccine recipients and 11 (30.6%) of 36 placebo recipients had histopathologic regression (percentage point difference [PPD], 19.0 [95% confidence interval CI, 1.4-36.6]; P = .034) (FIGURE 1). In the modified intention-to-treat analysis, 55 (48.2%) of 114 vaccine recipients and 12 (30.0%) of 40 placebo recipients had histopathologic regression (PPD, 18.2; 95% CI, 1.3-34.4; P = .034).
Injection-site reactions occurred in most patients, but only erythema was significantly more common in the vaccine group than in the placebo group (PPD, 21.3 [95% CI, 5.3-37.8]; P = .007).
What this evidence means for practice
In prior studies of immunotherapies, there have not been good correlations between immune responses and clinical responses, and this is one of the important differences between this study by Trimble and colleagues and prior studies in this space. Unfortunately, immune-based therapies are a "shot in the dark," with researchers not knowing which patients may have an increased immune response but no clinical response or a clinical response but no immune response. The measured immune responses are from peripheral blood, an immune response that might not reflect the milieu of immune responses in the cervical-vaginal tract.
If perfected, technologies like these hold the promise of minimizing the amount of patients who need to undergo excisional procedures because patients' own immune systems have been trained to target HPV-infected cells. The bigger hope is that we will be able to minimize preterm births that are directly related to treatment of dysplasia.
Adoptive T-cell therapy offers targeted treatment for recurrent cervical cancer
Stevanovic S, Draper LM, Langhan MM, et al. Complete regression of metastatic cervical cancer after treatment with human papillomavirus-targeted tumor-infiltrating T cells. J Clin Oncol. 2015;33(14):1543-1550.
Stevanovic and colleagues have been developing another immune-based therapy that has been tested for other cancers. This uses a method for generating T-cell cultures from HPV-positive cancers and selecting specific HPV oncoprotein- reactive cultures for administration to patients. Termed adoptive T-cell therapy (ACT), this targeted approach to recurrent cervical cancer is what I would consider one of the most intriguing future treatments of cervical disease. In the past, the largest barrier to an effective HPV vaccine to treat cervical cancer has been lack of clinical response to existing cytotoxic regimens. In this, albeit small, trial, investigators found a correlation between HPV reactivity and the infused T cells and objective clinical responses.
What is adoptive T-cell therapy?
ACT allows for more rigorous control over the magnitude of the targeted response than tumor vaccination treatment strategies because the T cells used for therapy are identified and selected in vitro. The cells selected are exposed to cytokines and immunomodulators that influence differentiation during priming and are expanded to large numbers. The resulting number of antigen-specific T cells produced in the peripheral blood is much greater (more than 10-fold) than that possible by current vaccine regimens alone.
Studies conducted by the National Cancer Institute of adoptive transfer of in vitro-selected tumor-infiltrating lymphocytes were the first to demonstrate the potential of T-cell immunotherapy to eradicate solid tumors.5,6 Among 13 patients with melanoma, treatment with adoptive transfer of ex vivo-amplified autologous tumor-infiltrating T cells resulted in treatment response in 10 of the patients—clinical responses in 6 and mixed responses in 4.
Details of the study
This study by Stevanovic and colleagues involved 9 patients with metastatic cervical cancer who previously had received optimal recommended chemotherapy or concomitant chemoradiotherapy regimens. Patients were treated with a single infusion of tumor-infiltrating T cells specifically selected for HPV E6 and E7 reactivity (HPV-TILs). Patients received lymphocyte-depleting chemotherapy before ACT and aldesleukin chemotherapy injection after ACT.
In such a phase I population, one would not expect clinical responses over persistent stable disease. However, in this small trial, 2 patients had complete tumor regression and 1 patient had a partial treatment response, demonstrating that a complete response to metastatic cervical cancer can occur after a single infusion of HPV-TILs. The partial response lasted 3 months. The 2 complete responses were ongoing 22 and 15 months after treatment (FIGURE 2).
Editorialists point out that, only when the infusion product had reactivity against the HPV E6 and E7 peptides did the patients show objective clinical response, suggesting it was the immune response that contributed to the tumor regression.7 In addition, in the 3 patients with objective responses, HPV-specific T cells persisted in peripheral blood for several months.
FIGURE 2 Patients with complete tumor responses with adoptive T-cell therapy | ||
Two patients with metastatic cervical cancer had complete tumor responses with treatment with tumor-infiltrating T cells selected for HPV E6 and E7 reactivity (HPV-TILs). Contrast-enhanced computed tomography scans obtained before treatment and at most recent follow-up for both patients. (A) First patient (patient 3) had disease involving para-aortic, bilateral hilar, subcarinal, and left iliac lymph nodes (gold arrows). Patient had no evidence of disease 22 months after treatment. (B) Second patient (patient 6) had metastatic disease in para-aortic lymph node, abdominal wall, aortocaval lymph node, left pericolic pelvic mass, and right ureteral nodule (gold arrows). Patient had no evidence of disease 15 months after treatment. (Red arrowhead indicates ureteral stent that was removed after right ureteral tumor regressed.) |
Stevanovic S, Draper LM, Langhan MM, et al. Complete regression of metastatic cervical cancer after treatment with human papillomavirus-targeted tumor-infiltrating T cells.J Clin Oncol. 2015;33(14):1543–1550. Used with permission.
What this evidence means for practice
The recent approval of bevacizumab has been a major breakthrough in the treatment of advanced and recurrent cervical cancer. Although ACT is a treatment that is in early clinical development, it is the next major advance in this area. Its promise is currently limited, as the process is cumbersome and complex, involving surgical removal of a patient's lymph nodes, culturing of the T cells from the lymph nodes, and infusing the T cells with the oncoproteins that will train those T cells to infiltrate the cancer tumor. The process is wrought with potential problems in laboratory and translational techniques. However, this group of investigators from the NCI has perfected the process of ACT, creating T cells that will target the HPV that is integrated into each cervical cancer tumor.
The patients who demonstrated good T-cell reactivity against HPV were the ones who had a treatment response, which demonstrates the targeted precision of ACT therapy. There might come a day when we can select patients with recurrent cervical cancer who are going to have T-cell reactivity, and send them for treatment to a center specialized in ACT. Typically in phase 1 trials, we are happy to see a number of patients responding with stable disease. In this trial, 2 patients had a complete response. The results demonstrated by Stevanovic and colleagues are very exciting for the future treatment of patients with cervical cancer.
Primary HPV screening shows up to 70% greater protection against invasive cervical cancer than cytology
Ronco G, Dillner J, Elfstrom KM; International HPV Screening Working Group. Efficacy of HPV-based screening for prevention of invasive cervical cancer: follow-up of four European randomised controlled trials. Lancet. 2014;383(9916):424-532.
In my 2015 "Update on Cervical Disease,"8 I discussed the newly published interim guidance for managing abnormal screening results for cervical cancer from a collective expert panel from the American Society for Colposcopy and Cervical Pathology, Society of Gynecologic Oncology, the American College of Obstetricians and Gynecologists, and 4 more societies.9 The guidelines support use of HPV testing alone or with the Papanicolaou test. In 2016, follow-up data from 4 RCTs provide long-term data on the efficacy of HPV primary testing.
Details of the trial
Incidence of invasive cervical cancer was the endpoint in 4 European trials comparing HPV-based with cytology-based screening. In total, 176,464 women aged 20 to 64 years were randomly assigned to either screening strategy. Median follow-up was 6.5 years (1,214,415 person-years). Using screening, pathology, and cancer registries investigators identified 107 invasive cervical carcinomas, with masked review of histologic specimens and reports.
Investigators calculated the rate ratios (defined as the cancer detection rate in the primary HPV testing-based versus cytology-based arms) for incidence of invasive cervical cancer. During the first 2.5 years of follow-up, detection of invasive cancer was similar between screening methods (0.79, 0.46-1.36). Thereafter, however, cumulative cancer detection was lower in the primary HPV testing-based arm (0.45; 95% CI, 0.25-0.81).
At 3.5 and 5.5 years after a negative cytology test on entry, cumulative cancer incidence was 15.4 per 105 (95% CI, 7.9-27.0) and 36.0 per 105 (23.2-53.5), respectively. At 3.5 and 5.5 years after a negative HPV test on entry, cumulative cancer incidence was 4.6 per 105 (1.1-12.1) and 8.7 per 105 (3.3-18.6), respectively (FIGURE 3).
FIGURE 3 Cumulative detection of invasive cervical carcinoma | ||
![]() | ||
*Observations are censored 2.5 years after CIN2 or CIN3 detection, if any.
|
What this EVIDENCE means for practice
The 4 studies in this report were completed across Europe (in England, Netherlands, Sweden, and Italy): different regions, different sites, hospitals, and screening systems. The women in Europe are not any different than the women in the United States in terms of rates of HPV and age and incidence of HPV. Therefore, these results are globally generalizable.
The US trial by Wright and colleagues10 that led to US Food and Drug Administration approval of HPV primary testing was different than this European study in that all trial sites had to perform screening in the same way. In addition, the end point was high-grade dysplasia; in this trial by Ronco and colleagues the end point is cancer. These current investigators found no difference with either screening arm in terms of detection of invasive cervical cancer. Even more interesting is that, over time, the cervical cancer rates in the primary HPV testing-based arm were much less than that in the cytology-based arm.
The real strengths of this study are the long-term follow-up and the study size. We are not likely to see validation cohorts this big again. This study demonstrates that, overall, we should be able to continue to reduce the incidence of invasive cervical cancer with a primary HPV testing-based screening strategy.
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.
- Conner SN, Frey HA, Cahill AG, Macones GA, Colditz GA, Tuuli MG. Loop electrosurgical excision procedure and risk of preterm birth: a systematic review and meta-analysis. Obstet Gynecol. 2014;123(4):752−761.
- Kyrgiou M, Valasoulis G, Stasinou SM, et al. Proportion of cervical excision for cervical intraepithelial neoplasia as a predictor of pregnancy outcomes. Int J Gynaecol Obstet. 2015;128(2):141−147.
- Miller ES, Grobman WA. The association between cervical excisional procedures, midtrimester cervical length, and preterm birth. Am J Obstet Gynecol. 2014;211(3):242.e1−e4.
- Martin JA, Hamilton BE, Osterman MJ, Curtin SC, Mathews TJ. Births: Final data for 2013. Natl Vital Stat Rep. 2015;64(1):1–65. http://www.cdc.gov/nchs/data/nvsr/nvsr64/nvsr64_01.pdf. Published January 15, 2015. Accessed April 20, 2016.
- Dudley ME, Wunderlich JR, Robbins PF, et al. Cancer regression and autoimmunity in patients after clonal repopulation with antitumor lymphocytes. Science. 2002;298(5594):850–854.
- Dudley ME, Wunderlich JR, Yang JC, et al. Adoptive cell transfer therapy following non-myeloablative but lymphodepleting chemotherapy for the treatment of patients with refractory metastatic melanoma. J Clin Oncol. 2005;23(10):2346−2357.
- Zsiros E, Tsuli T, Odunsi K. Adoptive T-cell therapy is a promising salvage approach for advanced or recurrent metastatic cervical cancer. J Clin Oncol. 2015;33(14):1521−1522.
- Einstein MH. Update on cervical disease: New ammo for HPV prevention and screening. OBG Manag. 2015;27(5):32−39.
- Huh WK, Ault KA, Chelmow D, et al. Use of primary high-risk human papillomavirus testing for cervical cancer screening: interim clinical guidance. Gynecol Oncol. 2015;136(2):178–182.
- Wright TC, Stoler MH, Behrens CM, Sharma A, Zhang G, Wright TL. Primary cervical cancer screening with human papillomavirus: end of study results from the ATHENA study using HPV as the first-line screening test. Gynecol Oncol. 2015;136(2):189–197.
- Conner SN, Frey HA, Cahill AG, Macones GA, Colditz GA, Tuuli MG. Loop electrosurgical excision procedure and risk of preterm birth: a systematic review and meta-analysis. Obstet Gynecol. 2014;123(4):752−761.
- Kyrgiou M, Valasoulis G, Stasinou SM, et al. Proportion of cervical excision for cervical intraepithelial neoplasia as a predictor of pregnancy outcomes. Int J Gynaecol Obstet. 2015;128(2):141−147.
- Miller ES, Grobman WA. The association between cervical excisional procedures, midtrimester cervical length, and preterm birth. Am J Obstet Gynecol. 2014;211(3):242.e1−e4.
- Martin JA, Hamilton BE, Osterman MJ, Curtin SC, Mathews TJ. Births: Final data for 2013. Natl Vital Stat Rep. 2015;64(1):1–65. http://www.cdc.gov/nchs/data/nvsr/nvsr64/nvsr64_01.pdf. Published January 15, 2015. Accessed April 20, 2016.
- Dudley ME, Wunderlich JR, Robbins PF, et al. Cancer regression and autoimmunity in patients after clonal repopulation with antitumor lymphocytes. Science. 2002;298(5594):850–854.
- Dudley ME, Wunderlich JR, Yang JC, et al. Adoptive cell transfer therapy following non-myeloablative but lymphodepleting chemotherapy for the treatment of patients with refractory metastatic melanoma. J Clin Oncol. 2005;23(10):2346−2357.
- Zsiros E, Tsuli T, Odunsi K. Adoptive T-cell therapy is a promising salvage approach for advanced or recurrent metastatic cervical cancer. J Clin Oncol. 2015;33(14):1521−1522.
- Einstein MH. Update on cervical disease: New ammo for HPV prevention and screening. OBG Manag. 2015;27(5):32−39.
- Huh WK, Ault KA, Chelmow D, et al. Use of primary high-risk human papillomavirus testing for cervical cancer screening: interim clinical guidance. Gynecol Oncol. 2015;136(2):178–182.
- Wright TC, Stoler MH, Behrens CM, Sharma A, Zhang G, Wright TL. Primary cervical cancer screening with human papillomavirus: end of study results from the ATHENA study using HPV as the first-line screening test. Gynecol Oncol. 2015;136(2):189–197.
In this article
• The success of adoptive T-cell therapy
• Long-term follow-up of primary HPV screening
Using videos to educate your ObGyn patients
Patient barriers to optimal health-care outcomes are well documented. According to a 2003 estimate from the National Center for Education Statistics, 9 in 10 individuals do not know how to adequately access information readily available for their own health care.1 A December 7, 2013, report in Modern Healthcare stated, “When patients are in doctors’ offices, they (might) hear 50% of what’s being said and maybe their relative hears another 30%, but they walk away without 20%.”2
In addition, patients often do not fill or refill their prescriptions. More than 31% of about 37,000 prescriptions written in a primary care setting for nearly 16,000 patients were not filled.3 Reasons may be poor health literacy, a medication’s expense, or disappointment with lack of drug efficacy. In a 2010 Commonwealth Fund survey, 23.1% of US patients reported not filling a drug prescription in the previous 12 months due to cost,4 and in 2012, 27% did not follow through with recommended testing or treatment.5
On the physician side, the advent of managed care, electronic health records, and requirements to document extraneous information have shortened “face time” with patients. This means less time to educate patients about their conditions and treatments. And patients who have insufficient information may have trouble adhering with recommendations and experience unsatisfactory outcomes.
Using focused patient-education videos can help you circumvent in-office time constraints and inform patients of their conditions and your recommendations, thereby increasing practice efficiency and improving patient outcomes. There are certain considerations you should keep in mind when implementing and executing videos for patients.
Planning your video
With videos, you can convey to patients the exact message you want them to receive. This is far more effective and more appreciatedthan videos distributed by pharmaceutical companies and vendors of equipment used in your office or hospital. If you do not have the time to create patient videos, purchasing professionally created videos could be worth the cost; however, those created by physicians are far better and can be a source of enhanced communication when patients see their own physician on the screen discussing the condition, procedure, or medications prescribed.
We suggest selecting topics you regularly discuss with patients. If the topic of prolapse arises several times a day or week, a video presentation about it would be appropriate. Other topics of interest to gynecology patients are shown in the TABLE. The topics included are those that many of our colleagues find that they discuss with patients frequently and are in need of an instructional video.
Example video topics for patient viewing
• Evaluation of urinary incontinence
• Recurrent urinary tract infection
• Infertility evaluation
• Options for hysterectomy
• Management of menometrorrhagia
• Contraception options (including bilateral tubal ligation)
• Pros and cons of hormone replacement therapy
• Breast self examination
One of us (NB) likes to select topics that are receiving lots of publicity. For example, when flibanserin was approved by the US Food and Drug Administration in 2015 and patients were asking about it, we created a video with a handout that summarized the drug’s actions and its adverse effects and that emphasized the precaution about using flibanserin in conjunction with alcohol.
Production elements
The script.
- Define the problem/condition
- Offer how the problem is evaluated
- Discuss treatment options
- Go over risks and complications
- Include a summary.
Embedding details of these bullet points into a PowerPoint presentation can serve as your teleprompter. Each video might end with the statement, “I hope you have found this video on <name of topic> informative. If you open the door at the end of the video, I will return to the examination room and provide you with a summary of the <topic> and answer any questions you may have.” We refer to this as the “sandwich technique,” in which the physician interacts with the patient first and performs the examination, invites the patient to watch the video, and returns to the room to conclude the patient visit.
The recording device. Recording can be accomplished easily with technology available in nearly every ObGyn office. You can use a video camera, the webcam on your computer, or a smart phone (probably the easiest choice). The quality of video created with the Apple, Samsung, or Motorola devices is excellent. The only other piece of equipment we recommend is a flexible tripod to hold the phone. Several such tripod stands are available for purchase, but the type with a flexible stand can be beneficial (FIGURE 1). These are available for purchase on Amazon.
FIGURE 1 Our recommended tripod stand | ||
| ||
The TriFlex Mini Phone Tripod Stand, available for purchase at retailers and at Amazon (http://www.amazon.com/dp/B017NA7V1U?psc=1). |
Putting it all together. With the smartphone in the tripod attached to the computer and the PowerPoint program serving as your notes, you are ready to create a video. We suggest limiting the recording to 5 to 7 minutes, the attention span of most patients. Those who want to produce a more professional looking video can use the editing programs iMovie on the Mac or Movie Maker on the PC.
Videos can be uploaded to your website, your EMR, or onto separate computers in each of your examination rooms. Depending on where you upload your videos (your own website or YouTube), patients can access them from home. An advantage of your own website and YouTube is that the videos can be viewed again and by patients’ significant others (which patients often inquire about the ability to do).
Other considerations
Videos that are conversational in nature, using the pronouns “I” and “we” and using such language as “my opinion” and “our patients” may hold the attention of viewers more than didactic “talking head” videos. In addition, creating videos on controversial topics that patients are interested in and need more information about can benefit patients and your practice.
Creating videos in other languages for your patients is an option as well. If you speak the language, then create your video in both English and the other language. Or you can create the script and ask a patient who speaks the non-English language to assist with the video production or voiceover. Also, there are other language videos for patients on YouTube. An excellent example of a Spanish-language gynecologic video on the pelvic examination is available (https://www.youtube.com/watch?v=IKsGYc-dCSI). It is easy to create a link from your website to a YouTube video. This requires requesting permission from the creator of the video. (We do not recommend showcasing another physician on your website.)
Example Patient education videos
Examples of videos on stress urinary incontinence and treatment with a midurethral sling can be viewed at: https://www.youtube.com/watch?v=BFZj8x3-oCA and https://www.youtube.com/watch?v=-gnOqkXiye0.
Dr. Neil Baum is the author of Social Media for the Healthcare Professional (Greenbranch Publishing, 2012).
Advantages of creating videos
When patients are watching the video, you can conduct visits with other patients and even perform brief office procedures. You can anticipate an up to 15% to 20% improvement in office efficiency by using educational videos. And patients will appreciate the information and the written summary accompanying each video.
Videos and medical-legal protection
Documentation is necessary to protect yourself from litigation. Record the viewing of a video in a patient’s chart, as well as the receipt of pertinent written information. We suggest you also note that all of the patient’s questions were answered before the patient left the office. To confirm that the patient understood the condition, procedure, or surgery, you can ask the patient to fill out a true/false questionnaire after watching the video and also include it in the chart. A questionnaire I (NB) use after the patient watches a video on stress incontinence is shown in FIGURE 2.
A statement to accompany the questionnaire is also a good idea. Example: “<name of patient> watched a video on the treatment of stress incontinence. The video discussed the procedure and its risks and complications, and alternate treatments, including the option to have no treatment. She agrees to proceeding with a midurethral sling using synthetic mesh and understands the risks and complications associated with the use of mesh.”
An additional helpful option is to end your videos with a comment that addresses the statement and consent form you will ask the patient to sign. For instance, “I will return to the examination room and provide you with a summary of the <topic> and answer any questions you may have. I also will ask you to sign a procedure or operative consent form as well as sign a statement that says you have watched the video, understand the content, and have had your questions answered.”
We believe that this makes the video an excellent medical-legal protection tool for the physician and that the video enhances the informed consent process.
Bottom line
We are challenged today to provide quality care in an efficient and cost-effective manner. This is a concern for every ObGyn practice regardless of its size or location or whether it is a solo or group practice or academic or private. We can improve our efficiency and our productivity, maintain quality of care, improve patient adherence, and even improve outcomes using patient videos. So get ready for lights, camera, and action!
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.
- Kutner M, Greenberg E, Jin Y, et al. The Health Literacy of America’s Adults: Results from the 2003 National Assessment of Adult Literacy. Washington, DC: National Center for Education Statistics, US Dept of Education, 2006.
- 1NCES publication 2006-483.2. Modern Healthcare. Providers help patients address emotion, money, health literacy. Available at: http://www.modernhealthcare.com/article/20131207/MAGAZINE/312079983. Accessed April 15, 2016.
- Tamblyn R, Eguale T, Huang A, Winsdale N, Doran P. The incidence and determinants of primary nonadherence with prescribed medication in primary care: a cohort study. Ann Intern Med. 2014;160(7):441–450.
- Morgan S, Kennedy J. Prescription drug accessibility and affordability in the United States and abroad. Issue Brief (Commonw Fund). 2010;89:1012.
- Collins SR, Robertson R, Garber T, et al. Insuring the future. Current trends in health coverage and the effects of implementing the Affordable Care Act. Available at: http://www.commonwealthfund.org/~/media/Files/Publications/Fund%20Report/2013/Apr/1681_Collins_insuring_future_biennial_survey_2012_FINAL.pdf. Accessed April 15, 2016.
Patient barriers to optimal health-care outcomes are well documented. According to a 2003 estimate from the National Center for Education Statistics, 9 in 10 individuals do not know how to adequately access information readily available for their own health care.1 A December 7, 2013, report in Modern Healthcare stated, “When patients are in doctors’ offices, they (might) hear 50% of what’s being said and maybe their relative hears another 30%, but they walk away without 20%.”2
In addition, patients often do not fill or refill their prescriptions. More than 31% of about 37,000 prescriptions written in a primary care setting for nearly 16,000 patients were not filled.3 Reasons may be poor health literacy, a medication’s expense, or disappointment with lack of drug efficacy. In a 2010 Commonwealth Fund survey, 23.1% of US patients reported not filling a drug prescription in the previous 12 months due to cost,4 and in 2012, 27% did not follow through with recommended testing or treatment.5
On the physician side, the advent of managed care, electronic health records, and requirements to document extraneous information have shortened “face time” with patients. This means less time to educate patients about their conditions and treatments. And patients who have insufficient information may have trouble adhering with recommendations and experience unsatisfactory outcomes.
Using focused patient-education videos can help you circumvent in-office time constraints and inform patients of their conditions and your recommendations, thereby increasing practice efficiency and improving patient outcomes. There are certain considerations you should keep in mind when implementing and executing videos for patients.
Planning your video
With videos, you can convey to patients the exact message you want them to receive. This is far more effective and more appreciatedthan videos distributed by pharmaceutical companies and vendors of equipment used in your office or hospital. If you do not have the time to create patient videos, purchasing professionally created videos could be worth the cost; however, those created by physicians are far better and can be a source of enhanced communication when patients see their own physician on the screen discussing the condition, procedure, or medications prescribed.
We suggest selecting topics you regularly discuss with patients. If the topic of prolapse arises several times a day or week, a video presentation about it would be appropriate. Other topics of interest to gynecology patients are shown in the TABLE. The topics included are those that many of our colleagues find that they discuss with patients frequently and are in need of an instructional video.
Example video topics for patient viewing
• Evaluation of urinary incontinence
• Recurrent urinary tract infection
• Infertility evaluation
• Options for hysterectomy
• Management of menometrorrhagia
• Contraception options (including bilateral tubal ligation)
• Pros and cons of hormone replacement therapy
• Breast self examination
One of us (NB) likes to select topics that are receiving lots of publicity. For example, when flibanserin was approved by the US Food and Drug Administration in 2015 and patients were asking about it, we created a video with a handout that summarized the drug’s actions and its adverse effects and that emphasized the precaution about using flibanserin in conjunction with alcohol.
Production elements
The script.
- Define the problem/condition
- Offer how the problem is evaluated
- Discuss treatment options
- Go over risks and complications
- Include a summary.
Embedding details of these bullet points into a PowerPoint presentation can serve as your teleprompter. Each video might end with the statement, “I hope you have found this video on <name of topic> informative. If you open the door at the end of the video, I will return to the examination room and provide you with a summary of the <topic> and answer any questions you may have.” We refer to this as the “sandwich technique,” in which the physician interacts with the patient first and performs the examination, invites the patient to watch the video, and returns to the room to conclude the patient visit.
The recording device. Recording can be accomplished easily with technology available in nearly every ObGyn office. You can use a video camera, the webcam on your computer, or a smart phone (probably the easiest choice). The quality of video created with the Apple, Samsung, or Motorola devices is excellent. The only other piece of equipment we recommend is a flexible tripod to hold the phone. Several such tripod stands are available for purchase, but the type with a flexible stand can be beneficial (FIGURE 1). These are available for purchase on Amazon.
FIGURE 1 Our recommended tripod stand | ||
| ||
The TriFlex Mini Phone Tripod Stand, available for purchase at retailers and at Amazon (http://www.amazon.com/dp/B017NA7V1U?psc=1). |
Putting it all together. With the smartphone in the tripod attached to the computer and the PowerPoint program serving as your notes, you are ready to create a video. We suggest limiting the recording to 5 to 7 minutes, the attention span of most patients. Those who want to produce a more professional looking video can use the editing programs iMovie on the Mac or Movie Maker on the PC.
Videos can be uploaded to your website, your EMR, or onto separate computers in each of your examination rooms. Depending on where you upload your videos (your own website or YouTube), patients can access them from home. An advantage of your own website and YouTube is that the videos can be viewed again and by patients’ significant others (which patients often inquire about the ability to do).
Other considerations
Videos that are conversational in nature, using the pronouns “I” and “we” and using such language as “my opinion” and “our patients” may hold the attention of viewers more than didactic “talking head” videos. In addition, creating videos on controversial topics that patients are interested in and need more information about can benefit patients and your practice.
Creating videos in other languages for your patients is an option as well. If you speak the language, then create your video in both English and the other language. Or you can create the script and ask a patient who speaks the non-English language to assist with the video production or voiceover. Also, there are other language videos for patients on YouTube. An excellent example of a Spanish-language gynecologic video on the pelvic examination is available (https://www.youtube.com/watch?v=IKsGYc-dCSI). It is easy to create a link from your website to a YouTube video. This requires requesting permission from the creator of the video. (We do not recommend showcasing another physician on your website.)
Example Patient education videos
Examples of videos on stress urinary incontinence and treatment with a midurethral sling can be viewed at: https://www.youtube.com/watch?v=BFZj8x3-oCA and https://www.youtube.com/watch?v=-gnOqkXiye0.
Dr. Neil Baum is the author of Social Media for the Healthcare Professional (Greenbranch Publishing, 2012).
Advantages of creating videos
When patients are watching the video, you can conduct visits with other patients and even perform brief office procedures. You can anticipate an up to 15% to 20% improvement in office efficiency by using educational videos. And patients will appreciate the information and the written summary accompanying each video.
Videos and medical-legal protection
Documentation is necessary to protect yourself from litigation. Record the viewing of a video in a patient’s chart, as well as the receipt of pertinent written information. We suggest you also note that all of the patient’s questions were answered before the patient left the office. To confirm that the patient understood the condition, procedure, or surgery, you can ask the patient to fill out a true/false questionnaire after watching the video and also include it in the chart. A questionnaire I (NB) use after the patient watches a video on stress incontinence is shown in FIGURE 2.
A statement to accompany the questionnaire is also a good idea. Example: “<name of patient> watched a video on the treatment of stress incontinence. The video discussed the procedure and its risks and complications, and alternate treatments, including the option to have no treatment. She agrees to proceeding with a midurethral sling using synthetic mesh and understands the risks and complications associated with the use of mesh.”
An additional helpful option is to end your videos with a comment that addresses the statement and consent form you will ask the patient to sign. For instance, “I will return to the examination room and provide you with a summary of the <topic> and answer any questions you may have. I also will ask you to sign a procedure or operative consent form as well as sign a statement that says you have watched the video, understand the content, and have had your questions answered.”
We believe that this makes the video an excellent medical-legal protection tool for the physician and that the video enhances the informed consent process.
Bottom line
We are challenged today to provide quality care in an efficient and cost-effective manner. This is a concern for every ObGyn practice regardless of its size or location or whether it is a solo or group practice or academic or private. We can improve our efficiency and our productivity, maintain quality of care, improve patient adherence, and even improve outcomes using patient videos. So get ready for lights, camera, and action!
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.
Patient barriers to optimal health-care outcomes are well documented. According to a 2003 estimate from the National Center for Education Statistics, 9 in 10 individuals do not know how to adequately access information readily available for their own health care.1 A December 7, 2013, report in Modern Healthcare stated, “When patients are in doctors’ offices, they (might) hear 50% of what’s being said and maybe their relative hears another 30%, but they walk away without 20%.”2
In addition, patients often do not fill or refill their prescriptions. More than 31% of about 37,000 prescriptions written in a primary care setting for nearly 16,000 patients were not filled.3 Reasons may be poor health literacy, a medication’s expense, or disappointment with lack of drug efficacy. In a 2010 Commonwealth Fund survey, 23.1% of US patients reported not filling a drug prescription in the previous 12 months due to cost,4 and in 2012, 27% did not follow through with recommended testing or treatment.5
On the physician side, the advent of managed care, electronic health records, and requirements to document extraneous information have shortened “face time” with patients. This means less time to educate patients about their conditions and treatments. And patients who have insufficient information may have trouble adhering with recommendations and experience unsatisfactory outcomes.
Using focused patient-education videos can help you circumvent in-office time constraints and inform patients of their conditions and your recommendations, thereby increasing practice efficiency and improving patient outcomes. There are certain considerations you should keep in mind when implementing and executing videos for patients.
Planning your video
With videos, you can convey to patients the exact message you want them to receive. This is far more effective and more appreciatedthan videos distributed by pharmaceutical companies and vendors of equipment used in your office or hospital. If you do not have the time to create patient videos, purchasing professionally created videos could be worth the cost; however, those created by physicians are far better and can be a source of enhanced communication when patients see their own physician on the screen discussing the condition, procedure, or medications prescribed.
We suggest selecting topics you regularly discuss with patients. If the topic of prolapse arises several times a day or week, a video presentation about it would be appropriate. Other topics of interest to gynecology patients are shown in the TABLE. The topics included are those that many of our colleagues find that they discuss with patients frequently and are in need of an instructional video.
Example video topics for patient viewing
• Evaluation of urinary incontinence
• Recurrent urinary tract infection
• Infertility evaluation
• Options for hysterectomy
• Management of menometrorrhagia
• Contraception options (including bilateral tubal ligation)
• Pros and cons of hormone replacement therapy
• Breast self examination
One of us (NB) likes to select topics that are receiving lots of publicity. For example, when flibanserin was approved by the US Food and Drug Administration in 2015 and patients were asking about it, we created a video with a handout that summarized the drug’s actions and its adverse effects and that emphasized the precaution about using flibanserin in conjunction with alcohol.
Production elements
The script.
- Define the problem/condition
- Offer how the problem is evaluated
- Discuss treatment options
- Go over risks and complications
- Include a summary.
Embedding details of these bullet points into a PowerPoint presentation can serve as your teleprompter. Each video might end with the statement, “I hope you have found this video on <name of topic> informative. If you open the door at the end of the video, I will return to the examination room and provide you with a summary of the <topic> and answer any questions you may have.” We refer to this as the “sandwich technique,” in which the physician interacts with the patient first and performs the examination, invites the patient to watch the video, and returns to the room to conclude the patient visit.
The recording device. Recording can be accomplished easily with technology available in nearly every ObGyn office. You can use a video camera, the webcam on your computer, or a smart phone (probably the easiest choice). The quality of video created with the Apple, Samsung, or Motorola devices is excellent. The only other piece of equipment we recommend is a flexible tripod to hold the phone. Several such tripod stands are available for purchase, but the type with a flexible stand can be beneficial (FIGURE 1). These are available for purchase on Amazon.
FIGURE 1 Our recommended tripod stand | ||
| ||
The TriFlex Mini Phone Tripod Stand, available for purchase at retailers and at Amazon (http://www.amazon.com/dp/B017NA7V1U?psc=1). |
Putting it all together. With the smartphone in the tripod attached to the computer and the PowerPoint program serving as your notes, you are ready to create a video. We suggest limiting the recording to 5 to 7 minutes, the attention span of most patients. Those who want to produce a more professional looking video can use the editing programs iMovie on the Mac or Movie Maker on the PC.
Videos can be uploaded to your website, your EMR, or onto separate computers in each of your examination rooms. Depending on where you upload your videos (your own website or YouTube), patients can access them from home. An advantage of your own website and YouTube is that the videos can be viewed again and by patients’ significant others (which patients often inquire about the ability to do).
Other considerations
Videos that are conversational in nature, using the pronouns “I” and “we” and using such language as “my opinion” and “our patients” may hold the attention of viewers more than didactic “talking head” videos. In addition, creating videos on controversial topics that patients are interested in and need more information about can benefit patients and your practice.
Creating videos in other languages for your patients is an option as well. If you speak the language, then create your video in both English and the other language. Or you can create the script and ask a patient who speaks the non-English language to assist with the video production or voiceover. Also, there are other language videos for patients on YouTube. An excellent example of a Spanish-language gynecologic video on the pelvic examination is available (https://www.youtube.com/watch?v=IKsGYc-dCSI). It is easy to create a link from your website to a YouTube video. This requires requesting permission from the creator of the video. (We do not recommend showcasing another physician on your website.)
Example Patient education videos
Examples of videos on stress urinary incontinence and treatment with a midurethral sling can be viewed at: https://www.youtube.com/watch?v=BFZj8x3-oCA and https://www.youtube.com/watch?v=-gnOqkXiye0.
Dr. Neil Baum is the author of Social Media for the Healthcare Professional (Greenbranch Publishing, 2012).
Advantages of creating videos
When patients are watching the video, you can conduct visits with other patients and even perform brief office procedures. You can anticipate an up to 15% to 20% improvement in office efficiency by using educational videos. And patients will appreciate the information and the written summary accompanying each video.
Videos and medical-legal protection
Documentation is necessary to protect yourself from litigation. Record the viewing of a video in a patient’s chart, as well as the receipt of pertinent written information. We suggest you also note that all of the patient’s questions were answered before the patient left the office. To confirm that the patient understood the condition, procedure, or surgery, you can ask the patient to fill out a true/false questionnaire after watching the video and also include it in the chart. A questionnaire I (NB) use after the patient watches a video on stress incontinence is shown in FIGURE 2.
A statement to accompany the questionnaire is also a good idea. Example: “<name of patient> watched a video on the treatment of stress incontinence. The video discussed the procedure and its risks and complications, and alternate treatments, including the option to have no treatment. She agrees to proceeding with a midurethral sling using synthetic mesh and understands the risks and complications associated with the use of mesh.”
An additional helpful option is to end your videos with a comment that addresses the statement and consent form you will ask the patient to sign. For instance, “I will return to the examination room and provide you with a summary of the <topic> and answer any questions you may have. I also will ask you to sign a procedure or operative consent form as well as sign a statement that says you have watched the video, understand the content, and have had your questions answered.”
We believe that this makes the video an excellent medical-legal protection tool for the physician and that the video enhances the informed consent process.
Bottom line
We are challenged today to provide quality care in an efficient and cost-effective manner. This is a concern for every ObGyn practice regardless of its size or location or whether it is a solo or group practice or academic or private. We can improve our efficiency and our productivity, maintain quality of care, improve patient adherence, and even improve outcomes using patient videos. So get ready for lights, camera, and action!
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.
- Kutner M, Greenberg E, Jin Y, et al. The Health Literacy of America’s Adults: Results from the 2003 National Assessment of Adult Literacy. Washington, DC: National Center for Education Statistics, US Dept of Education, 2006.
- 1NCES publication 2006-483.2. Modern Healthcare. Providers help patients address emotion, money, health literacy. Available at: http://www.modernhealthcare.com/article/20131207/MAGAZINE/312079983. Accessed April 15, 2016.
- Tamblyn R, Eguale T, Huang A, Winsdale N, Doran P. The incidence and determinants of primary nonadherence with prescribed medication in primary care: a cohort study. Ann Intern Med. 2014;160(7):441–450.
- Morgan S, Kennedy J. Prescription drug accessibility and affordability in the United States and abroad. Issue Brief (Commonw Fund). 2010;89:1012.
- Collins SR, Robertson R, Garber T, et al. Insuring the future. Current trends in health coverage and the effects of implementing the Affordable Care Act. Available at: http://www.commonwealthfund.org/~/media/Files/Publications/Fund%20Report/2013/Apr/1681_Collins_insuring_future_biennial_survey_2012_FINAL.pdf. Accessed April 15, 2016.
- Kutner M, Greenberg E, Jin Y, et al. The Health Literacy of America’s Adults: Results from the 2003 National Assessment of Adult Literacy. Washington, DC: National Center for Education Statistics, US Dept of Education, 2006.
- 1NCES publication 2006-483.2. Modern Healthcare. Providers help patients address emotion, money, health literacy. Available at: http://www.modernhealthcare.com/article/20131207/MAGAZINE/312079983. Accessed April 15, 2016.
- Tamblyn R, Eguale T, Huang A, Winsdale N, Doran P. The incidence and determinants of primary nonadherence with prescribed medication in primary care: a cohort study. Ann Intern Med. 2014;160(7):441–450.
- Morgan S, Kennedy J. Prescription drug accessibility and affordability in the United States and abroad. Issue Brief (Commonw Fund). 2010;89:1012.
- Collins SR, Robertson R, Garber T, et al. Insuring the future. Current trends in health coverage and the effects of implementing the Affordable Care Act. Available at: http://www.commonwealthfund.org/~/media/Files/Publications/Fund%20Report/2013/Apr/1681_Collins_insuring_future_biennial_survey_2012_FINAL.pdf. Accessed April 15, 2016.
In this article
• Videos and medical-legal protection
• Patient questionnaire post-video viewing
Fistula developed after delivery: $50M verdict
Fistula developed after delivery: $50M verdict
During delivery of a 31-year-old woman's baby, a nuchal cord was encountered. In order to safely deliver the child, the ObGyn performed an episiotomy.
After delivery, the patient reported an odorous vaginal discharge. The ObGyn explained that the condition was a natural byproduct of delivery and suggested that it would resolve without treatment.
The patient became pregnant a second time shortly after her first delivery and was evaluated by a midwife. The patient again reported the odorous discharge, but the condition was not addressed. At delivery of her second child, the ObGyn determined that the patient had a rectovaginal fistula. The patient underwent 13 repair operations.
PATIENT’S CLAIM:
The fistula was a byproduct of the episiotomy performed during the first delivery. The episiotomy should not have been performed. The ObGyn should have diagnosed and treated the fistula prior to delivery of the second child and performed a cesarean delivery.
DEFENDANT'S DEFENSE:
The ObGyn reported that the patient's medical records showed that she did not report the odorous discharge until after her second delivery.
VERDICT:
A New York $50 million verdict was returned.
Related article:
Management of wound complications following obstetric anal sphincter injury (OASIS)
Abdominal wall hematoma during pregnancy: $2.5M award
At 35 weeks' gestation, a 38-year-old woman presented to the emergency department (ED) with right upper abdominal pain. Her pregnancy was at high risk because of her age and the fact that she had thrombophilia involving both factor V and protein S deficiency. During pregnancy she was anticoagulated. She had been coughing from bronchitis, which was treated with antibiotics and an inhaler.
In the ED, laboratory testing determined that her blood was not properly clotting. Upper abdominal ultrasonography (US) showed an abdominal wall hematoma and gall stones. The ED physician, after contacting the on-call ObGyn, told the patient that nothing further could be done until after the baby's birth and prescribed medications for nausea and pain. The patient was discharged.
Thirty-three hours later, the patient was rushed to the hospital after she was found barely responsive, pale, and in severe pain. US results showed that the hematoma had grown extensively. The patient was in hypovolemic shock having lost more than 50% of her blood volume. She was admitted to the intensive care unit.
After induced labor, a stillborn son was delivered. The autopsy report revealed that the child died from either asphyxiation or an hypoxic ischemic event that occurred when the mother went into shock.
PATIENT’S CLAIM:
The ED physician and staff were negligent. Once the hematoma was identified, the standard of care is to monitor the hematoma with regular US. Instead, the ED physician discharged the patient. The ED physician contacted the on-call ObGyn but did not ask for a consult. The patient should have been admitted for monitoring.
DEFENDANT'S DEFENSE:
The ED physician met the standard of care. The mother's condition would likely have been detected during a nonstress test scheduled for the following day but the mother missed the prenatal exam because she had just left the hospital.
VERDICT:
A $2.5 million Missouri verdict was returned.
Incorrect due date, child with brain injuries: $1.2M
When a pregnant woman presented for her first prenatal visit, she was unsure of the date of her last menstrual period. During subsequent prenatal visits, she underwent 3 ultrasounds.
Labor was induced on August 1 because she reported gastrointestinal reflux. The infant appeared healthy at birth but soon went into respiratory distress. He was slow to meet developmental goals and was believed to be autistic. At age 5 years, he was given a diagnosis of periventricular leukomalacia.
PARENT’S CLAIM:
The child, 11 years old at the time of trial, has permanent brain injuries due to premature delivery. The mother's due date should have been projected as August 25 according to prenatal US measurements. The ObGyn misinterpreted the US data and estimated a due date of August 15. Therefore induction on August 1st caused him to be premature.
PHYSICIAN’S DEFENSE:
The standard of care was met. Gestational age evaluation using US is an estimate based on the child's size at specific time points, not an exact calculation, especially if the mother is not sure about the date of her last menses.
VERDICT:
A $1.2 million New Jersey verdict was returned.
Related article:
Three good apps for calculating the date of delivery
Bacterial infection blamed for birth injury
A woman was at 28 weeks' gestation when her membranes ruptured on September 28. She began to leak amniotic fluid and was put on bed rest. She saw her ObGyn on October 13 with signs of a bacterial infection of her membranes. The ObGyn decided to induce labor; a baby girl was born 11 hours later. The child had meningitis at birth and other infection-related complications including a brain hemorrhage. She continues to have permanent neurologic deficits.
PARENT’S CLAIM:
The ObGyn was negligent in not immediately delivering the child via cesarean delivery on October 13. The delay exposed the baby to infection for 11 more hours; the extended exposure led to her permanent injury.
PHYSICIAN’S DEFENSE:
The patient's treatment met the standard of care.
VERDICT:
A Virginia 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.
Fistula developed after delivery: $50M verdict
During delivery of a 31-year-old woman's baby, a nuchal cord was encountered. In order to safely deliver the child, the ObGyn performed an episiotomy.
After delivery, the patient reported an odorous vaginal discharge. The ObGyn explained that the condition was a natural byproduct of delivery and suggested that it would resolve without treatment.
The patient became pregnant a second time shortly after her first delivery and was evaluated by a midwife. The patient again reported the odorous discharge, but the condition was not addressed. At delivery of her second child, the ObGyn determined that the patient had a rectovaginal fistula. The patient underwent 13 repair operations.
PATIENT’S CLAIM:
The fistula was a byproduct of the episiotomy performed during the first delivery. The episiotomy should not have been performed. The ObGyn should have diagnosed and treated the fistula prior to delivery of the second child and performed a cesarean delivery.
DEFENDANT'S DEFENSE:
The ObGyn reported that the patient's medical records showed that she did not report the odorous discharge until after her second delivery.
VERDICT:
A New York $50 million verdict was returned.
Related article:
Management of wound complications following obstetric anal sphincter injury (OASIS)
Abdominal wall hematoma during pregnancy: $2.5M award
At 35 weeks' gestation, a 38-year-old woman presented to the emergency department (ED) with right upper abdominal pain. Her pregnancy was at high risk because of her age and the fact that she had thrombophilia involving both factor V and protein S deficiency. During pregnancy she was anticoagulated. She had been coughing from bronchitis, which was treated with antibiotics and an inhaler.
In the ED, laboratory testing determined that her blood was not properly clotting. Upper abdominal ultrasonography (US) showed an abdominal wall hematoma and gall stones. The ED physician, after contacting the on-call ObGyn, told the patient that nothing further could be done until after the baby's birth and prescribed medications for nausea and pain. The patient was discharged.
Thirty-three hours later, the patient was rushed to the hospital after she was found barely responsive, pale, and in severe pain. US results showed that the hematoma had grown extensively. The patient was in hypovolemic shock having lost more than 50% of her blood volume. She was admitted to the intensive care unit.
After induced labor, a stillborn son was delivered. The autopsy report revealed that the child died from either asphyxiation or an hypoxic ischemic event that occurred when the mother went into shock.
PATIENT’S CLAIM:
The ED physician and staff were negligent. Once the hematoma was identified, the standard of care is to monitor the hematoma with regular US. Instead, the ED physician discharged the patient. The ED physician contacted the on-call ObGyn but did not ask for a consult. The patient should have been admitted for monitoring.
DEFENDANT'S DEFENSE:
The ED physician met the standard of care. The mother's condition would likely have been detected during a nonstress test scheduled for the following day but the mother missed the prenatal exam because she had just left the hospital.
VERDICT:
A $2.5 million Missouri verdict was returned.
Incorrect due date, child with brain injuries: $1.2M
When a pregnant woman presented for her first prenatal visit, she was unsure of the date of her last menstrual period. During subsequent prenatal visits, she underwent 3 ultrasounds.
Labor was induced on August 1 because she reported gastrointestinal reflux. The infant appeared healthy at birth but soon went into respiratory distress. He was slow to meet developmental goals and was believed to be autistic. At age 5 years, he was given a diagnosis of periventricular leukomalacia.
PARENT’S CLAIM:
The child, 11 years old at the time of trial, has permanent brain injuries due to premature delivery. The mother's due date should have been projected as August 25 according to prenatal US measurements. The ObGyn misinterpreted the US data and estimated a due date of August 15. Therefore induction on August 1st caused him to be premature.
PHYSICIAN’S DEFENSE:
The standard of care was met. Gestational age evaluation using US is an estimate based on the child's size at specific time points, not an exact calculation, especially if the mother is not sure about the date of her last menses.
VERDICT:
A $1.2 million New Jersey verdict was returned.
Related article:
Three good apps for calculating the date of delivery
Bacterial infection blamed for birth injury
A woman was at 28 weeks' gestation when her membranes ruptured on September 28. She began to leak amniotic fluid and was put on bed rest. She saw her ObGyn on October 13 with signs of a bacterial infection of her membranes. The ObGyn decided to induce labor; a baby girl was born 11 hours later. The child had meningitis at birth and other infection-related complications including a brain hemorrhage. She continues to have permanent neurologic deficits.
PARENT’S CLAIM:
The ObGyn was negligent in not immediately delivering the child via cesarean delivery on October 13. The delay exposed the baby to infection for 11 more hours; the extended exposure led to her permanent injury.
PHYSICIAN’S DEFENSE:
The patient's treatment met the standard of care.
VERDICT:
A Virginia 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.
Fistula developed after delivery: $50M verdict
During delivery of a 31-year-old woman's baby, a nuchal cord was encountered. In order to safely deliver the child, the ObGyn performed an episiotomy.
After delivery, the patient reported an odorous vaginal discharge. The ObGyn explained that the condition was a natural byproduct of delivery and suggested that it would resolve without treatment.
The patient became pregnant a second time shortly after her first delivery and was evaluated by a midwife. The patient again reported the odorous discharge, but the condition was not addressed. At delivery of her second child, the ObGyn determined that the patient had a rectovaginal fistula. The patient underwent 13 repair operations.
PATIENT’S CLAIM:
The fistula was a byproduct of the episiotomy performed during the first delivery. The episiotomy should not have been performed. The ObGyn should have diagnosed and treated the fistula prior to delivery of the second child and performed a cesarean delivery.
DEFENDANT'S DEFENSE:
The ObGyn reported that the patient's medical records showed that she did not report the odorous discharge until after her second delivery.
VERDICT:
A New York $50 million verdict was returned.
Related article:
Management of wound complications following obstetric anal sphincter injury (OASIS)
Abdominal wall hematoma during pregnancy: $2.5M award
At 35 weeks' gestation, a 38-year-old woman presented to the emergency department (ED) with right upper abdominal pain. Her pregnancy was at high risk because of her age and the fact that she had thrombophilia involving both factor V and protein S deficiency. During pregnancy she was anticoagulated. She had been coughing from bronchitis, which was treated with antibiotics and an inhaler.
In the ED, laboratory testing determined that her blood was not properly clotting. Upper abdominal ultrasonography (US) showed an abdominal wall hematoma and gall stones. The ED physician, after contacting the on-call ObGyn, told the patient that nothing further could be done until after the baby's birth and prescribed medications for nausea and pain. The patient was discharged.
Thirty-three hours later, the patient was rushed to the hospital after she was found barely responsive, pale, and in severe pain. US results showed that the hematoma had grown extensively. The patient was in hypovolemic shock having lost more than 50% of her blood volume. She was admitted to the intensive care unit.
After induced labor, a stillborn son was delivered. The autopsy report revealed that the child died from either asphyxiation or an hypoxic ischemic event that occurred when the mother went into shock.
PATIENT’S CLAIM:
The ED physician and staff were negligent. Once the hematoma was identified, the standard of care is to monitor the hematoma with regular US. Instead, the ED physician discharged the patient. The ED physician contacted the on-call ObGyn but did not ask for a consult. The patient should have been admitted for monitoring.
DEFENDANT'S DEFENSE:
The ED physician met the standard of care. The mother's condition would likely have been detected during a nonstress test scheduled for the following day but the mother missed the prenatal exam because she had just left the hospital.
VERDICT:
A $2.5 million Missouri verdict was returned.
Incorrect due date, child with brain injuries: $1.2M
When a pregnant woman presented for her first prenatal visit, she was unsure of the date of her last menstrual period. During subsequent prenatal visits, she underwent 3 ultrasounds.
Labor was induced on August 1 because she reported gastrointestinal reflux. The infant appeared healthy at birth but soon went into respiratory distress. He was slow to meet developmental goals and was believed to be autistic. At age 5 years, he was given a diagnosis of periventricular leukomalacia.
PARENT’S CLAIM:
The child, 11 years old at the time of trial, has permanent brain injuries due to premature delivery. The mother's due date should have been projected as August 25 according to prenatal US measurements. The ObGyn misinterpreted the US data and estimated a due date of August 15. Therefore induction on August 1st caused him to be premature.
PHYSICIAN’S DEFENSE:
The standard of care was met. Gestational age evaluation using US is an estimate based on the child's size at specific time points, not an exact calculation, especially if the mother is not sure about the date of her last menses.
VERDICT:
A $1.2 million New Jersey verdict was returned.
Related article:
Three good apps for calculating the date of delivery
Bacterial infection blamed for birth injury
A woman was at 28 weeks' gestation when her membranes ruptured on September 28. She began to leak amniotic fluid and was put on bed rest. She saw her ObGyn on October 13 with signs of a bacterial infection of her membranes. The ObGyn decided to induce labor; a baby girl was born 11 hours later. The child had meningitis at birth and other infection-related complications including a brain hemorrhage. She continues to have permanent neurologic deficits.
PARENT’S CLAIM:
The ObGyn was negligent in not immediately delivering the child via cesarean delivery on October 13. The delay exposed the baby to infection for 11 more hours; the extended exposure led to her permanent injury.
PHYSICIAN’S DEFENSE:
The patient's treatment met the standard of care.
VERDICT:
A Virginia 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.
Ectopic pregnancy misdiagnosed
Ectopic pregnancy misdiagnosed
When a patient called her ObGyn (Dr. A) to report that she was 6 weeks' pregnant and had lower abdominal pain, she was seen by his partner (Dr. B). Dr. B could not identify an intrauterine pregnancy using ultrasonography (US), but the patient's hCG level was highly suggestive of an ectopic pregnancy. The next day, Dr. B performed exploratory laparoscopy, found no evidence of an ectopic pregnancy, and removed the patient's appendix. He continued to be concerned about the possibility of an ectopic pregnancy and suggested that the patient terminate the pregnancy. The next day he prescribed methotrexate. A week later, US revealed a fetus in utero with a beating heart. Because of the likelihood of birth defects after methotrexate use, Dr. B recommended terminating the pregnancy; an abortion was performed a month later.
PATIENT’S CLAIM:
Dr. B should have waited for the pathology report on the appendix and repeated the US before rushing into advising termination of pregnancy.
PHYSICIAN’S CLAIM :
Dr. B acted reasonably based on the patient's symptoms.
VERDICT:
A Kentucky defense verdict was returned.
Related article:
Stop using the hCG discriminatory zone of 1,500 to 2,000 mIU/mL to guide intervention during early pregnancy
Hemorrhage after trocar insertion
A gynecologist performed laparoscopic hysterectomy on his 46-year-old patient. During trocar insertion, the patient's iliac artery, iliac vein, and small bowel were injured. The patient hemorrhaged and went into cardiac arrest. The patient was given several transfusions and the injuries were repaired.
One day after discharge, she returned to the hospital with symptoms of an embolism; she was treated with anticoagulants for 1 year. A year after surgery, she was informed that she was transfused during surgery with HIV-positive blood. Her initial HIV test came back negative.
PATIENT’S CLAIM:
The gynecologist deviated from the standard of care by performing a "blind" trocar insertion, which caused the major vessels to be more susceptible to injury.
PHYSICIAN’S DEFENSE:
There was no deviation from the standard of care. Blind insertion of a trocar is an acceptable procedure.
VERDICT:
A $383,000 Illinois verdict was returned.
Related article:
How to avoid major vessel injury during gynecologic laparoscopy
Delay in ovarian cancer diagnosis: $1.9M settlement
A 64-year-old woman reported worsening abdominal pain, fatigue, and unexplained weight loss to her primary care physician. The physician did not order tests to assess the patient's status; he diagnosed gastritis. Several months later the patient saw another physician, who ordered imaging and identified stage IV ovarian clear cell carcinoma.
PATIENT’S CLAIM:
Timely imaging would have diagnosed ovarian cancer at stage I or II and given her a 90% survival rate at 10 years. Due to the diagnostic delay, her survival rate was less than 10% at 10 years.
PHYSICIAN’S DEFENSE:
The case settled before trial.
VERDICT:
A $1.9 million Illinois settlement was reached.
Late breast cancer diagnosis: $1.7M settlement
When a 25-year-old woman found a lump in her left breast she saw her gynecologist, who recommended US and fine-needle aspiration biopsy. US results indicated possible cancer; biopsy results were reported as negative for cancer. No further action was taken.
Eight months later, a second physician diagnosed stage IV breast cancer requiring chemotherapy, radiation therapy, and multiple surgeries.
PATIENT’S CLAIM:
The radiologist misread the fine-needle aspiration biopsy results. The gynecologist should have ordered a core needle biopsy because it is more reliable.
PHYSICIAN’S DEFENSE:
The case was settled during the trial.
VERDICT:
A $3.5 million Illinois settlement was reached.
Perforated colon after oophorectomy
A 55-year-old woman underwent laparoscopic oophorectomy to address pelvic pain and a right ovarian mass. Following surgery she developed peritonitis and sepsis. She underwent a colon resection with colostomy and had severe keloid scarring.
PATIENT’S CLAIM:
The surgeon was well aware of her history of extensive pelvic adhesions. Given her medical history, he should have performed an open laparotomy.
PHYSICIAN’S DEFENSE:
The case settled during trial.
VERDICT:
A $700,000 Illinois settlement was reached.
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.
Ectopic pregnancy misdiagnosed
When a patient called her ObGyn (Dr. A) to report that she was 6 weeks' pregnant and had lower abdominal pain, she was seen by his partner (Dr. B). Dr. B could not identify an intrauterine pregnancy using ultrasonography (US), but the patient's hCG level was highly suggestive of an ectopic pregnancy. The next day, Dr. B performed exploratory laparoscopy, found no evidence of an ectopic pregnancy, and removed the patient's appendix. He continued to be concerned about the possibility of an ectopic pregnancy and suggested that the patient terminate the pregnancy. The next day he prescribed methotrexate. A week later, US revealed a fetus in utero with a beating heart. Because of the likelihood of birth defects after methotrexate use, Dr. B recommended terminating the pregnancy; an abortion was performed a month later.
PATIENT’S CLAIM:
Dr. B should have waited for the pathology report on the appendix and repeated the US before rushing into advising termination of pregnancy.
PHYSICIAN’S CLAIM :
Dr. B acted reasonably based on the patient's symptoms.
VERDICT:
A Kentucky defense verdict was returned.
Related article:
Stop using the hCG discriminatory zone of 1,500 to 2,000 mIU/mL to guide intervention during early pregnancy
Hemorrhage after trocar insertion
A gynecologist performed laparoscopic hysterectomy on his 46-year-old patient. During trocar insertion, the patient's iliac artery, iliac vein, and small bowel were injured. The patient hemorrhaged and went into cardiac arrest. The patient was given several transfusions and the injuries were repaired.
One day after discharge, she returned to the hospital with symptoms of an embolism; she was treated with anticoagulants for 1 year. A year after surgery, she was informed that she was transfused during surgery with HIV-positive blood. Her initial HIV test came back negative.
PATIENT’S CLAIM:
The gynecologist deviated from the standard of care by performing a "blind" trocar insertion, which caused the major vessels to be more susceptible to injury.
PHYSICIAN’S DEFENSE:
There was no deviation from the standard of care. Blind insertion of a trocar is an acceptable procedure.
VERDICT:
A $383,000 Illinois verdict was returned.
Related article:
How to avoid major vessel injury during gynecologic laparoscopy
Delay in ovarian cancer diagnosis: $1.9M settlement
A 64-year-old woman reported worsening abdominal pain, fatigue, and unexplained weight loss to her primary care physician. The physician did not order tests to assess the patient's status; he diagnosed gastritis. Several months later the patient saw another physician, who ordered imaging and identified stage IV ovarian clear cell carcinoma.
PATIENT’S CLAIM:
Timely imaging would have diagnosed ovarian cancer at stage I or II and given her a 90% survival rate at 10 years. Due to the diagnostic delay, her survival rate was less than 10% at 10 years.
PHYSICIAN’S DEFENSE:
The case settled before trial.
VERDICT:
A $1.9 million Illinois settlement was reached.
Late breast cancer diagnosis: $1.7M settlement
When a 25-year-old woman found a lump in her left breast she saw her gynecologist, who recommended US and fine-needle aspiration biopsy. US results indicated possible cancer; biopsy results were reported as negative for cancer. No further action was taken.
Eight months later, a second physician diagnosed stage IV breast cancer requiring chemotherapy, radiation therapy, and multiple surgeries.
PATIENT’S CLAIM:
The radiologist misread the fine-needle aspiration biopsy results. The gynecologist should have ordered a core needle biopsy because it is more reliable.
PHYSICIAN’S DEFENSE:
The case was settled during the trial.
VERDICT:
A $3.5 million Illinois settlement was reached.
Perforated colon after oophorectomy
A 55-year-old woman underwent laparoscopic oophorectomy to address pelvic pain and a right ovarian mass. Following surgery she developed peritonitis and sepsis. She underwent a colon resection with colostomy and had severe keloid scarring.
PATIENT’S CLAIM:
The surgeon was well aware of her history of extensive pelvic adhesions. Given her medical history, he should have performed an open laparotomy.
PHYSICIAN’S DEFENSE:
The case settled during trial.
VERDICT:
A $700,000 Illinois settlement was reached.
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.
Ectopic pregnancy misdiagnosed
When a patient called her ObGyn (Dr. A) to report that she was 6 weeks' pregnant and had lower abdominal pain, she was seen by his partner (Dr. B). Dr. B could not identify an intrauterine pregnancy using ultrasonography (US), but the patient's hCG level was highly suggestive of an ectopic pregnancy. The next day, Dr. B performed exploratory laparoscopy, found no evidence of an ectopic pregnancy, and removed the patient's appendix. He continued to be concerned about the possibility of an ectopic pregnancy and suggested that the patient terminate the pregnancy. The next day he prescribed methotrexate. A week later, US revealed a fetus in utero with a beating heart. Because of the likelihood of birth defects after methotrexate use, Dr. B recommended terminating the pregnancy; an abortion was performed a month later.
PATIENT’S CLAIM:
Dr. B should have waited for the pathology report on the appendix and repeated the US before rushing into advising termination of pregnancy.
PHYSICIAN’S CLAIM :
Dr. B acted reasonably based on the patient's symptoms.
VERDICT:
A Kentucky defense verdict was returned.
Related article:
Stop using the hCG discriminatory zone of 1,500 to 2,000 mIU/mL to guide intervention during early pregnancy
Hemorrhage after trocar insertion
A gynecologist performed laparoscopic hysterectomy on his 46-year-old patient. During trocar insertion, the patient's iliac artery, iliac vein, and small bowel were injured. The patient hemorrhaged and went into cardiac arrest. The patient was given several transfusions and the injuries were repaired.
One day after discharge, she returned to the hospital with symptoms of an embolism; she was treated with anticoagulants for 1 year. A year after surgery, she was informed that she was transfused during surgery with HIV-positive blood. Her initial HIV test came back negative.
PATIENT’S CLAIM:
The gynecologist deviated from the standard of care by performing a "blind" trocar insertion, which caused the major vessels to be more susceptible to injury.
PHYSICIAN’S DEFENSE:
There was no deviation from the standard of care. Blind insertion of a trocar is an acceptable procedure.
VERDICT:
A $383,000 Illinois verdict was returned.
Related article:
How to avoid major vessel injury during gynecologic laparoscopy
Delay in ovarian cancer diagnosis: $1.9M settlement
A 64-year-old woman reported worsening abdominal pain, fatigue, and unexplained weight loss to her primary care physician. The physician did not order tests to assess the patient's status; he diagnosed gastritis. Several months later the patient saw another physician, who ordered imaging and identified stage IV ovarian clear cell carcinoma.
PATIENT’S CLAIM:
Timely imaging would have diagnosed ovarian cancer at stage I or II and given her a 90% survival rate at 10 years. Due to the diagnostic delay, her survival rate was less than 10% at 10 years.
PHYSICIAN’S DEFENSE:
The case settled before trial.
VERDICT:
A $1.9 million Illinois settlement was reached.
Late breast cancer diagnosis: $1.7M settlement
When a 25-year-old woman found a lump in her left breast she saw her gynecologist, who recommended US and fine-needle aspiration biopsy. US results indicated possible cancer; biopsy results were reported as negative for cancer. No further action was taken.
Eight months later, a second physician diagnosed stage IV breast cancer requiring chemotherapy, radiation therapy, and multiple surgeries.
PATIENT’S CLAIM:
The radiologist misread the fine-needle aspiration biopsy results. The gynecologist should have ordered a core needle biopsy because it is more reliable.
PHYSICIAN’S DEFENSE:
The case was settled during the trial.
VERDICT:
A $3.5 million Illinois settlement was reached.
Perforated colon after oophorectomy
A 55-year-old woman underwent laparoscopic oophorectomy to address pelvic pain and a right ovarian mass. Following surgery she developed peritonitis and sepsis. She underwent a colon resection with colostomy and had severe keloid scarring.
PATIENT’S CLAIM:
The surgeon was well aware of her history of extensive pelvic adhesions. Given her medical history, he should have performed an open laparotomy.
PHYSICIAN’S DEFENSE:
The case settled during trial.
VERDICT:
A $700,000 Illinois settlement was reached.
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.
Webcast: Providing LARC methods of contraception to adolescents
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:
- Emergency contraception: How to choose the right one for your patient
- 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:
- Emergency contraception: How to choose the right one for your patient
- 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:
- Emergency contraception: How to choose the right one for your patient
- 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.