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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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On-site reporting from the Society of Gynecologic Surgeons 2016 annual meeting
4/13/16. DAY 4 AT SGS
A jam-packed day of sessions, posters, awards, and clinical updates
Our last educational day was kicked off by a fascinating lecture by Dr. Amy Park on the “Genetic Determinants of Pelvic Organ Prolapse in Women of European American Descent: The Women’s Health Initiative.” Dr. Park and her colleagues found that there is evidence of phenotypic and genotypic heterogeneity in patients with pelvic organ prolapse, and there were 4 genetic loci identified that correlated with prolapse. Any uterine prolapse was associated with a genome-wide significant intergenic variant on chromosome 13, cystocele was associated with LOXL2, and all prolapse was associated with BMP.
Surmounting surgical site infection
Dr. Sarah Andiman then gave a lecture on the effects of a perioperative bundle and offered timely feedback for surgical site infection (SSI) prevention in hysterectomy. We all know that wound infections are a major morbidity associated with surgery, and Dr. Andiman’s group at Yale found that, by implementing this prevention program, the surgical site infection decreased 52.8%. Another suggestion from the audience was to have all patients use chlorhexidine wipes the night before and morning of a surgery to decrease wound infection. Similarly, Dr. Ali Bazzi gave a lecture on “Chlorhexidine-Alcohol Compared with Povidone-Iodine for Surgical-Site Antisepsis after Abdominal Hysterectomy.” The chlorhexidine was associated with 30% lower odds of SSI compared with povidone-iodine, even though this group had several medical comorbidities and risk factors known for SSIs.
Oral poster presenters make several interesting points
Dr. Christopher Ripperda from UT Southwestern Medical Center in Dallas, Texas, found that medical comorbidities and the presence of detrusor overactivity and PVR are predictors of early postoperative voiding dysfunction following a midurethral sling placement. Dr. Nabila Noor then described a fabulous surgical alternative to the use of morcellation to remove the uterus after a supracervical hysterectomy. She described the technique for performing a posterior colpotomy and stated that patients who had a surgery performed at her institution using this technique did not experience increased postoperative pain or longer postoperative stay.
Dr. Jennifer Thompson then shed some light on a very important question related to the Sunshine Act: Are physicians including all of their disclosures when they submit articles to a conference? When the physicians who submitted an abstract to the Society of Gynecologic Surgeons (SGS) in 2015 were searched on the Centers for Medicare and Medicaid Services (CMS) website, 62% of them had incomplete disclosures, with a total of nondisclosed CMS transactions equaling $1.3 million. We can do better!
Status update: The FPRN and passing of the torch
Congratulations to Dr. Kristin Jacobs, the new Fellows’ Pelvic Research Network (FPRN) Chair! The morning session ended with an innovative video from Dr. Janet Li and colleagues on the “Use of Suprapubic Carter-Thomason Needle to Assist in Cystoscopic Excision of Intravesical Foreign Object.”
The winner of the Distinguished Surgeon Award was given to Dr. Javier Magrina, and the SGS gavel was passed on to Dr. Vivian Sung! Congratulations!
Dr. Stephanie Pickett kicked off the eighth scientific session with a study entitled, “Comparing Methods of NSAID Delivery for Postoperative Pain.” When she and her colleagues compared IV toradol to IV ibuprofen for postoperative pain control after urogynecologic surgery, they found that patients experienced similar rates of pain control and satisfaction regardless of the type of analgesia.
Why are patients being readmitted after gynecologic oncology surgery?
The answer to this question is important as readmission rates are being considered for physician and hospital reimbursement. Dr. MaryAnn Wilbur and colleagues looked at the rates of unplanned 30-day readmission in gyn oncology patients. The patients who were readmitted had the following characteristics: ovarian cancer, creation of ostomy, Charleston score >5, language barrier, and positive discharge screen. Gastrointestinal disturbance and SSI were the most common reasons for readmission, and the total readmission-related costs for these patients was about $4.5 million.
Considering tissue extraction, surgical complications, and cognitive impairment
We then had 3 fabulous oral poster presentations. Dr. Emily Von Bargen and colleagues presented a study entitled, “Prevalence of Occult Pre-malignant or Malignant Pathology at the time of Uterine Morcellation for Benign Disease.” They performed a multicenter retrospective cohort study and found that 1.2% of women had a premalignant or malignant uterine pathology after surgery, with a prevalence of 0.66% of occult malignancy. She was unable to identify risk factors for those patients who had a premalignant or malignant pathology. Overall she found a low prevalence of premalignant or malignant uterine pathology when uterine morcellation was performed for benign disease.
Dr. Alix Leader-Cramer from Northwestern University pointed out “risk factors for a 30-day perioperative complications for total vaginal hysterectomy,” including chronic steroid use, higher ASA classification, current smoking status, diabetes, and lower preoperative serum albumin and sodium levels. Adnexectomy and resident participation were also associated with increased perioperative complications. About 9.5% of patients had a perioperative complication in the study population studied.
Finally, Dr. Elisa Trowbridge pointed out in her talk, on “Cognitive Impairment among Elderly Urogynecologic Patients,” that cognitive impairment is very prevalent among such women aged older than 75 years, and the Mini-Cog is a feasible screening tool.
What a way to end an AMAZING conference!
The conference ended with a fabulous video presentation by Dr. Andrea Benton, entitled “Surgical Approaches to the Management of Bladder and Ureteral Endometriosis.” Overall, the themes of this year’s SGS conference were to:
- emphasize the importance of performing a vaginal hysterectomy when feasible
- continue to strive to balance innovation with experimentation
- ensure that patients are being operated on by surgeons who are competent and frequently performing the indicated procedure.
Thank you to everyone who shared their research to educate the attendees at the conference! I can’t wait until next year!
4/12/16. DAY 3 AT SGS
Vaginal hysterectomy, fecal incontinence, transgender surgery amid tackled topics in Palm Springs
I could get used to sipping my coffee with the sunny background here in Palm Springs! It was a beautiful morning to learn.
We started the day with breakfast and a fabulous lecture on the inferior gluteal neurovascular anatomy in female cadavers, and an insightful lecture by Dr. Bhumy Dave, who brought up concerns about tracking for obstetrics and gynecology residency programs. She specifically highlighted the need for more experience with vaginal hysterectomies for residents who are going to be in a subspecialty that performs vaginal surgery. As the number of hysterectomies, specifically vaginal hysterectomies, declines every year, we need to make sure we are adequately training the physicians who will be performing this procedure in the future. One solution is to have residents join a track their 4th year of residency, after their future career path has been established. Another possible solution would be to increase use of a simulation model for vaginal hysterectomy, as described by Dr. Douglas Miyazaki.
Indigo carmine replacement? A recent issue in gynecologic surgery resulted when there was a national shortage of indigo carmine, which is commonly used to identify UO efflux at the time of cystoscopy. Dr. Katie Propst provided a solution: In the setting of planned cystoscopy, she found that preoperative phenazopyridine is an acceptable alternative and its use led to similar UO identification as with indigo carmine without an increase in complications.
Who should have a vaginal hysterectomy? Dr. Jennifer Schmitt from the Mayo Clinic gave another wonderful lecture describing a decision-tree algorithm for determining the ideal route of hysterectomy. According to a retrospective review of patients at their institution, vaginal hysterectomy was associated with lower infection rates, operative times, and costs.
The highlight of the morning was a very insightful Presidential Address by Dr. Andrew Walter! Not only is a he a very entertaining speaker but he also shed some light on 2 challenges that we currently face in the field. He eloquently stated that, “every woman who is a candidate for a vaginal hysterectomy should be able to get one and have it performed competently, and every woman who needs surgery should have one performed by someone who performs enough surgeries every year to competently perform the surgery.” He frequently alluded to the wise Dr. Mayo, who stated, “The best interest of the patient is the only interest to be considered…” Let’s never forget this as physicians!
Do you find removing the adnexa challenging when performing vaginal surgery? Check out the amazing idea from the Cleveland Clinic shown in video presentation 05! They clearly demonstrate using a single-site gel port or surgical glove placed in the vaginal incision to perform laparoscopy through the vagina. What a novel idea to avoid any abdominal incisions when there is a difficult vaginal adnexal surgery!
After the morning break, we watched a master vaginal surgeon perform a sacral colpopexy through the vaginal route. For details on this method, please reference video presentation 06.
An increase in health care costs is a huge problem in this country. Dr. Mary Van Meter suggested that one area in which we can improve is in the operating room (OR), specifically through decreasing the number of instruments sterilized. She found that only approximately 20% of the instruments on the operating field were actually used by the OR physician. It costs about $3 per instrument on the tray at Vanderbilt University, she said. When you think of the few number of instruments actually used, if we work to limit the number of instruments on the trays, we could cut significant costs. As reimbursement is getting increasingly linked to cost reduction, we all should be thinking about innovative ways to cut costs.
The oral posters were all excellent!
Dr. Ann Peters showed that, at a high-volume tertiary-care center, multimodal preoperative testing failed to definitively identify leiomyosarcoma (LMS), and the factors associated with increased LMS risk included older age, menopause, and presence of fibroids with concurrent pelvic, uterine, or adnexal mass.
Dr. Kevin Kremer found that preoperative antibiotics were used in 23% of cases in which they were not indicated, and the increased use rate was associated with entrance into the abdomen during surgery, the individual surgeon, and time under anesthesia.
Dr. Jessica Heft then stated that the incontinence rate after midurethral sling revision for vaginal exposure or pain was significantly higher with a partial as opposed to complete mesh excision.
Fecal incontinence treatment options
Dr. Peter Rosenblatt tackled the issue of “Innovation or experimentation: Where do we draw the line?” in the TeLinde lecture. He started by describing a condition for which he feels we do not have an acceptable amount of treatment options for patients: fecal incontinence. He described how he observed that the puborectalis muscle, not the external anal sphincter, was critical for fecal continence. He then devised a surgery that created a sling that would act as a synthetic puborectalis muscle. He had amazing success until one patient had a serious complication. Should you abandon a successful, innovative surgery due to one very severe complication, was the question. Where do we draw the line? I don’t have an answer…but I do know that we all need to thank our puborectalis muscle for our daily fecal continence!
This is not a new issue in medicine, explained Dr. Rosenblatt. From the beginning of medicine, there has been a balance between innovation and experimentation. So, what is innovation? It is when someone improves upon a device or process. In medicine, is it innovation or just variation? We frequently use medications and devices “off label,” and these techniques often improve our surgeries and outcomes for our patients. Innovation comes about through careful planning, a necessity created by an emergency, advances in technology, and through evolution of a procedure. Who are the innovators? YOU are! We are the ones who understand the unmet needs and the potential opportunities for improving medicine. Let’s all work together to innovate NOT experiment and make medicine better so our patients have the best care possible!
“New Frontiers in Gynecologic Surgery: Transgender Surgery and Functional Clitoroplasty after Female Genital Mutilation”
The final talk for the day was by the groundbreaking Dr. Marci Bowers, whose lecture started by reminding everyone that there is a difference between gender identity and gender expression. Once a person knows his or her gender identity they use gender expression to express this to the world, she pointed out. Dr. Bowers is a true innovator and is performing gender reassignment surgeries as well as female genital mutilation corrective surgeries. She has perfected a one-stage vaginoplasty, and she showed a video of the procedure, which results in a 90% chance of orgasm. She also noted that she is able to restore clitoral function in 100% of the cases of genital mutilation, and she performs these procedures free of charge.
She reminded us that all ObGyns need to be trained in treating transgender patients, and given the high rate of suicide among adolescent transgender individuals, we all need to work together to provide a supportive medical environment to help these patients. What a fascinating end to the day!
Some relaxation, and entertainment, amid the sun and outdoors
We then had the afternoon to compete in a golf tournament, explore the area on mountain bikes, or lounge by the pool. Regardless of the daytime activities, we all came back together for the great lip-synch competition! All 4 teams gave an impressive performance, but the team from Brown University went home with the win! Such an entertaining event! (Thanks to incoming SGS President Vivian Sung @wih_sung for the pic!)
4/11/16. DAY 2 AT SGS
Experts talk surgical innovations, complementary therapies, value-based payment, and much more at SGS day 2
Wake up and learn! The second day of the 42nd Annual Scientific Meeting of the Society of Gynecologic Surgeons began with a review of research posters at the Poster Session as the sun rose over the Palm Springs mountains. We then moved indoors for the scientific sessions.
In the first lecture, "Reasons for Unplanned 30-Day Readmission After Hysterectomy for Benign Disease," Dr. Courtney Penn and colleagues reiterated that the postsurgical readmission rate is higher for patients undergoing abdominal hysterectomy compared with those who have a laparoscopic or vaginal hysterectomy. Similarly, Dr. Jennifer Schmitt and colleagues suggested that in a patient with a relative contraindication for vaginal hysterectomy, when this procedure is performed by an experienced surgeon there may not be increased complications. However, keep in mind that the study described—"A Comparison of Vaginal and Robotic Hysterectomy for Commonly Cited Relative Contraindications to Vaginal Hysterectomy"—was performed at the Mayo Clinic by expert, highly trained surgeons, and this fact may limit the generalizability of the study. As one audience member eloquently stated, it is important to remember that: "Just because it is feasible does not mean it is the correct procedure."
That yoga or barre class may be doing more good than you think! Lunge, bridge, and cat-into-cow movements may provide a greater degree of pelvic floor muscle unit recruitment than traditional Kegel exercises, according to a presentation by Dr. Bruce Crawford on Kegels versus specialized movement.
Perhaps those exercises should be recommended for surgeons as well. As Dr. Ruchira Singh pointed out, surgeons experience a high amount of musculoskeletal strain when performing vaginal procedures while sitting, regardless of the type of chair used during surgery. Dr. Singh and colleagues’ study, "Effect of Different Chairs on Work-Related Musculoskeletal Discomfort During Vaginal Surgery," found that while the round stool with a backrest and the Capisco chair were more comfortable, they did not eliminate the high risk for musculoskeletal strain, particularly in the head and neck.
Dr. Ann Peters and colleagues, from Magee-Womens Hospital of the University of Pittsburgh Medical Center, gave a fabulous video presentation on "Anatomic and Vascular Considerations in Laparoscopic Uterine Artery Ligation During Hysterectomy."
Need a novel treatment for interstitial cystitis/bladder pain syndrome? Consider mindfulness-based stress reduction. A randomized controlled study performed by Dr. Gregg Kanter and colleagues describes how this technique may help patients and could be considered a first-line therapy.
What is value-based payment and this new trend in reimbursement? And how does it apply to vaginal hysterectomy? Dr. Tina Groat addressed these issues in her keynote lecture. According to the American Congress of Obstetricians and Gynecologists, “Evidence demonstrates that, in general, vaginal hysterectomy is associated with better outcomes and fewer complications than laparoscopic or abdominal hysterectomy.” This is in opposition to what is actually being performed clinically. Dr. Groat explained that United Healthcare decided to incentivize physicians by requiring a prior authorization for all hysterectomies for benign disease. There is both a quality and cost benefit to performing a vaginal hysterectomy. Most insurance companies are moving away from a “fee for service” structure to performance-based payment. Change is always scary and, while I think the overall goal of moving toward the best care for our patients is a positive, this approach may create new challenges for the medical field. What do you think? Is performance-based payment beneficial? Or does it limit physicians and potentially force them to perform a procedure they do not feel as comfortable performing? Will this result in physicians rejecting certain patient populations? [Note from OBG MANAGEMENT: Let Dr. Collins know your thoughts through social media, or email OBG MANAGEMENT with a Letter to the Editor (rbarbieri@frontlinemedcom.com).]
The debate on the best route for hysterectomy continues: According to Dr. Carolyn Swenson and colleagues in their presentation, "Comparison of Robotic and Other Minimally Invasive Routes of Hysterectomy for Benign Indications," while there may be lower complications associated with robotic hysterectomy, the cost of performing a robotic hysterectomy is significantly higher than the cost of laparoscopic or vaginal hysterectomy, thus limiting its utility.
How can we teach a rare surgical procedure to learners? We channel our inner Martha Stewart and make a model out of a beef tongue and chicken. For about $8 a challenging and rare surgery can be taught to residents and medical students, according to the video presentation by Dr. Jana Illston and colleagues, titled "Modified Beef Tongue Model for Fourth-Degree Laceration Repair Simulation."
After the Day 2 lunch break, there was a rousing debate surrounding "Surgeons as Innovators—What Is the Patient Expecting?" Where do we draw the line between using an older more proven therapy as opposed to trying an innovative technology that may actually offer a potential benefit? Dr. Dennis Miller made a good point regarding innovation and pharmaceutical and device companies: If we ignore industry, we lose the ability to help with innovation and shape the future of medical treatments. Perhaps we should use the golden rule: If we would perform the surgery or use the device on ourselves, then we should perform it on our patient. Patients have a greater burden now, because there are more treatment options that they must choose among. Our job as physicians is to educate our patients and to guide them to innovative and evidence-based treatments.
Highlights from the afternoon oral poster session included a presentation by Dr. Caryn Russman that noted the high risk for recurrent urinary tract infection (UTI) after a mid-urethral sling procedure, which seems to be related to specific preoperative risk factors (such as a history of recurrent UTI). Dr. Tanya Hoke suggested that residents and attending physicians have inaccurate estimates of uterine weight, and an educational program may be necessary to improve these estimates. Finally, a study from Massachusetts General Hospital showed that a shorter stay in the hospital, ideally same-day surgery, resulted in a lower complication risk, lower number of emergency department visits, and a decreased readmission rate for patients undergoing urogynecology procedures.
The following recommendations were then suggested regarding vaginal hysterectomy:
- Preoperative prep with 4% chlorhexidine or povidine iodine
- Intracervical vasopressin injection to decrease blood loss
- Use of a pedicle-sealing device for pedicle ligation
- Vertical cuff closure is preferred to maximize vaginal length
Another important point made was that a prior cesarean delivery is not a contraindication to performing a vaginal hysterectomy.
Recommendations regarding recurrent UTI were also made, which include the recommendation for preoperative use of antibiotics to decrease the rate of UTI, with no benefit for a longer course of antibiotics.
News from the Fellows’ Pelvic Research Network
So much exciting research currently is ongoing with the FPRN! New project ideas include comparison of trimethoprim with methenamie for treatment of recurrent UTI; comparison of laparoscopic/robotic sacrocolpopexy with vaginal USLS for management of apical prolapse; a survey study examining surgeon preferences for timing of midurethral sling placement when performed at the time of pelvic organ prolapse (POP) repair; an assessment of the effect of a midurethal sling on overactive bladder in surgical repair in POP; and a study evaluating female pelvic reconstructive surgery in the setting of human immunodeficiency virus infection. It is so great to see the fellows working together to provide groundbreaking research!
Fun with stats
Learning statistics at the end of the day is never easy, but Dr. Matthew Barber did a fabulous job explaining this often-confusing topic. He reminded attendees that the key to learning statistics is repetition. One new recommendation he offered to enhance understanding is to use common language instead of numbers for P values. For example, instead of saying P <.001, use “is superior,” and instead of saying P = .3, use “seems not superior” or “inconclusive.”
A night to remember
The night ended with a wonderful awards ceremony and the president’s reception. Overall, day 2 was a very educational—and fun—day!
4/10/16. DAY 1 AT SGS
Postgrad courses address pain management and social media education
Mastering pelvic pain
With the beautiful Palm Springs, California, backdrop of mountains and palm trees, the 2016 meeting of the Society of Gynecologic Surgeons kicked off with 4 postgraduate courses. At the “Mastering Pelvic Pain: Strategies and Techniques for a Multimodal Approach” course, directed by Dr. Cara King, Dr. Matt Siedhoff explained the key components of the history and physical examination: Keep in mind that this generally is a multifactorial issue and may require a multidisciplinary approach, he told attendees. It is also important to make sure that the patient is fully prepared to combat the chronic pelvic pain (CPP) symptoms by focusing on the fundamentals, he said, including smoking, diet, exercise, weight loss, sleep, and relationship stress.
How is your posture? It turns out that something as simple as altering your posture can significantly affect pelvic floor control. Carol Sobeck, PT, demonstrated this importance with a simple group exercise that proved how the ability to contract the pelvic floor changes significantly with posture. Get to know your pelvic floor physical therapist—they are critical in helping with the treatment of CPP.
But what to do when physical therapy fails? Dr. Jennifer Gunter shed some light on this very difficult medical situation. One suggestion, she said, is to consider the possibility of a local presentation of a systemic issue and screen for the following: fibromyalgia, Ehlers-Danlos syndrome, statin use, and diabetes mellitus. Other treatment ideas include trigger point injections and onabotulinumtoxin A (Botox) therapy. A trigger point is a hypercontracted focus of muscle. To treat a trigger point, a needle must mechanically disrupt the trigger point to reduce the pelvic pain, and injection of local anesthetic is only used to help with postprocedure discomfort. Botox in my pelvis, you ask? Yes! The goal is to block presynaptic release of acetylcholine, which is very effective at reducing muscle spasm.
Tackling endometriosis. Dr. King then described surgical techniques for endometriosis. She recommended that, for mild disease not in close proximity to vital structures, ablation is likely equivalent to excision. For deeply infiltrating endometriosis, or lesions in close proximity to vital structures, excision is more beneficial. Excision is always beneficial for pathologic diagnosis, she said. And she offered this tip for bladder endometriosis: place a stitch in the nodule to allow for counter traction. Here is another tip, for ovarian cystectomy: inject vasopressin (20 U in 60 mL) to help dissect the plane between the ovary and cyst wall, and consider presacral neurectomy for midline pain.
Dr. Frank Tu then explained that we should not think of it as the “terrible triad: endometriosis, irritable bowel syndrome, and interstitial cystsis,” but rather as a system out of balance. Both peripheral and central mechanisms are involved in the generation and maintenance of cross-organ sensitization, he pointed out, which may explain why patients receive multiple diagnoses that describe a myriad of complaints due to a lack of overall homeostasis.
While Dr. Alaa Abd-Elsayed described innovative nerve blocks for CPP, he emphasized that no one specific treatment will result in a complete resolution of symptoms.
Vaginal mesh placement and pain. Dr. Mario Castellanos gave a fabulous lecture describing the pain issues that surround vaginal mesh placement. Interestingly, he noted that many patients had pelvic pain prior to placement of vaginal mesh, and that pain likely only will worsen with mesh placement. Mesh may cause pain by causing inflammation, visceral injury, muscle injury, and nerve injury. While there are guidelines for where mesh should be placed for bladder slings (TVT and TOT) and for prolapse repair, studies show, he pointed out, that the mesh placement often disrupts several muscle groups and may directly injure a nerve.
Alternatives to the typical diagnoses for CPP. The morning ended with a lecture by Dr. Suzie As-Sanie, in which she reminded everyone to start with “gold standard” therapy but, if those fail, consider alternative diagnoses or a central pain disorder. She also suggested cognitive behavioral therapy for treatment of CPP. For patients who cannot afford cognitive behavioral therapy, there is a free online source at fibroguide.med.umich.edu. Other alternative treatment options include exercise, patient education, instruction on sleep hygiene, and neurostimulatory therapies.
Overall, all the speakers this morning agreed that CPP is rarely treated with one modality, and it is best treated with a multidisciplinary approach.
Let’s get social!
The afternoon was spent learning about ways to use social networking sites to educate our patients, in another postgraduate course on “Making Media Social,” presented by the SGS Social Media Committee. Given that a recent survey demonstrated that 74.1% of women have some type of social networking account, it can be a very useful source for medical information for patients. If you have any questions about what is appropriate on social media, check out ACOG committee opinion 622.
Here are some tips that I learned:
Facebook:
- Keep your private Facebook page private and create a separate professional Facebook page
- Adjust your login setting so only administrators can post on your professional page
- Adjust settings so your professional profile cannot be “tagged”
- If a patient contacts your personal page, direct them to your professional page
- Do not give medical advice since Facebook is not digitally encrypted
Twitter:
- “Short bursts of inconsequential information”
- Follow societies, medical centers, and medical journals
LinkedIn:
- It provides a great way to find jobs, people, and business opportunities that are recommended by someone in your contact group
- It is specifically there to help you grow your business and show people who you are and where you have come from
Doximity:
Before we get to tips, first, what is it? Well, Doximity is basically a “LinkedIn” for physicians. It is “a way to find relevant specialists for patients; a rolodex; an email and text service; and a virtual lounge.” It is currently transforming from social network into a ‘platform.’ Now more than 1,000 hospitals and health systems are part of Doximity. Tips:
- There is a secure message option, which is HIPAA compliant
- Provides a way for residents and fellows to understand possible future places of employment
- It is a great way to find someone to refer patients to in an unfamiliar location
Vimeo:
- A benefit over YouTube is the lack of advertisements
- Check out the SGS video archives!
- You also can set privacy settings and embedding stats
Fifty-nine percent of US adults have looked online for health information in the past year. Therefore, it is important for physicians to get good information out for people to see!
A relaxing day’s end
The night ended with a beautiful poolside reception! I can’t wait to see what day 2 will bring!
4/13/16. DAY 4 AT SGS
A jam-packed day of sessions, posters, awards, and clinical updates
Our last educational day was kicked off by a fascinating lecture by Dr. Amy Park on the “Genetic Determinants of Pelvic Organ Prolapse in Women of European American Descent: The Women’s Health Initiative.” Dr. Park and her colleagues found that there is evidence of phenotypic and genotypic heterogeneity in patients with pelvic organ prolapse, and there were 4 genetic loci identified that correlated with prolapse. Any uterine prolapse was associated with a genome-wide significant intergenic variant on chromosome 13, cystocele was associated with LOXL2, and all prolapse was associated with BMP.
Surmounting surgical site infection
Dr. Sarah Andiman then gave a lecture on the effects of a perioperative bundle and offered timely feedback for surgical site infection (SSI) prevention in hysterectomy. We all know that wound infections are a major morbidity associated with surgery, and Dr. Andiman’s group at Yale found that, by implementing this prevention program, the surgical site infection decreased 52.8%. Another suggestion from the audience was to have all patients use chlorhexidine wipes the night before and morning of a surgery to decrease wound infection. Similarly, Dr. Ali Bazzi gave a lecture on “Chlorhexidine-Alcohol Compared with Povidone-Iodine for Surgical-Site Antisepsis after Abdominal Hysterectomy.” The chlorhexidine was associated with 30% lower odds of SSI compared with povidone-iodine, even though this group had several medical comorbidities and risk factors known for SSIs.
Oral poster presenters make several interesting points
Dr. Christopher Ripperda from UT Southwestern Medical Center in Dallas, Texas, found that medical comorbidities and the presence of detrusor overactivity and PVR are predictors of early postoperative voiding dysfunction following a midurethral sling placement. Dr. Nabila Noor then described a fabulous surgical alternative to the use of morcellation to remove the uterus after a supracervical hysterectomy. She described the technique for performing a posterior colpotomy and stated that patients who had a surgery performed at her institution using this technique did not experience increased postoperative pain or longer postoperative stay.
Dr. Jennifer Thompson then shed some light on a very important question related to the Sunshine Act: Are physicians including all of their disclosures when they submit articles to a conference? When the physicians who submitted an abstract to the Society of Gynecologic Surgeons (SGS) in 2015 were searched on the Centers for Medicare and Medicaid Services (CMS) website, 62% of them had incomplete disclosures, with a total of nondisclosed CMS transactions equaling $1.3 million. We can do better!
Status update: The FPRN and passing of the torch
Congratulations to Dr. Kristin Jacobs, the new Fellows’ Pelvic Research Network (FPRN) Chair! The morning session ended with an innovative video from Dr. Janet Li and colleagues on the “Use of Suprapubic Carter-Thomason Needle to Assist in Cystoscopic Excision of Intravesical Foreign Object.”
The winner of the Distinguished Surgeon Award was given to Dr. Javier Magrina, and the SGS gavel was passed on to Dr. Vivian Sung! Congratulations!
Dr. Stephanie Pickett kicked off the eighth scientific session with a study entitled, “Comparing Methods of NSAID Delivery for Postoperative Pain.” When she and her colleagues compared IV toradol to IV ibuprofen for postoperative pain control after urogynecologic surgery, they found that patients experienced similar rates of pain control and satisfaction regardless of the type of analgesia.
Why are patients being readmitted after gynecologic oncology surgery?
The answer to this question is important as readmission rates are being considered for physician and hospital reimbursement. Dr. MaryAnn Wilbur and colleagues looked at the rates of unplanned 30-day readmission in gyn oncology patients. The patients who were readmitted had the following characteristics: ovarian cancer, creation of ostomy, Charleston score >5, language barrier, and positive discharge screen. Gastrointestinal disturbance and SSI were the most common reasons for readmission, and the total readmission-related costs for these patients was about $4.5 million.
Considering tissue extraction, surgical complications, and cognitive impairment
We then had 3 fabulous oral poster presentations. Dr. Emily Von Bargen and colleagues presented a study entitled, “Prevalence of Occult Pre-malignant or Malignant Pathology at the time of Uterine Morcellation for Benign Disease.” They performed a multicenter retrospective cohort study and found that 1.2% of women had a premalignant or malignant uterine pathology after surgery, with a prevalence of 0.66% of occult malignancy. She was unable to identify risk factors for those patients who had a premalignant or malignant pathology. Overall she found a low prevalence of premalignant or malignant uterine pathology when uterine morcellation was performed for benign disease.
Dr. Alix Leader-Cramer from Northwestern University pointed out “risk factors for a 30-day perioperative complications for total vaginal hysterectomy,” including chronic steroid use, higher ASA classification, current smoking status, diabetes, and lower preoperative serum albumin and sodium levels. Adnexectomy and resident participation were also associated with increased perioperative complications. About 9.5% of patients had a perioperative complication in the study population studied.
Finally, Dr. Elisa Trowbridge pointed out in her talk, on “Cognitive Impairment among Elderly Urogynecologic Patients,” that cognitive impairment is very prevalent among such women aged older than 75 years, and the Mini-Cog is a feasible screening tool.
What a way to end an AMAZING conference!
The conference ended with a fabulous video presentation by Dr. Andrea Benton, entitled “Surgical Approaches to the Management of Bladder and Ureteral Endometriosis.” Overall, the themes of this year’s SGS conference were to:
- emphasize the importance of performing a vaginal hysterectomy when feasible
- continue to strive to balance innovation with experimentation
- ensure that patients are being operated on by surgeons who are competent and frequently performing the indicated procedure.
Thank you to everyone who shared their research to educate the attendees at the conference! I can’t wait until next year!
4/12/16. DAY 3 AT SGS
Vaginal hysterectomy, fecal incontinence, transgender surgery amid tackled topics in Palm Springs
I could get used to sipping my coffee with the sunny background here in Palm Springs! It was a beautiful morning to learn.
We started the day with breakfast and a fabulous lecture on the inferior gluteal neurovascular anatomy in female cadavers, and an insightful lecture by Dr. Bhumy Dave, who brought up concerns about tracking for obstetrics and gynecology residency programs. She specifically highlighted the need for more experience with vaginal hysterectomies for residents who are going to be in a subspecialty that performs vaginal surgery. As the number of hysterectomies, specifically vaginal hysterectomies, declines every year, we need to make sure we are adequately training the physicians who will be performing this procedure in the future. One solution is to have residents join a track their 4th year of residency, after their future career path has been established. Another possible solution would be to increase use of a simulation model for vaginal hysterectomy, as described by Dr. Douglas Miyazaki.
Indigo carmine replacement? A recent issue in gynecologic surgery resulted when there was a national shortage of indigo carmine, which is commonly used to identify UO efflux at the time of cystoscopy. Dr. Katie Propst provided a solution: In the setting of planned cystoscopy, she found that preoperative phenazopyridine is an acceptable alternative and its use led to similar UO identification as with indigo carmine without an increase in complications.
Who should have a vaginal hysterectomy? Dr. Jennifer Schmitt from the Mayo Clinic gave another wonderful lecture describing a decision-tree algorithm for determining the ideal route of hysterectomy. According to a retrospective review of patients at their institution, vaginal hysterectomy was associated with lower infection rates, operative times, and costs.
The highlight of the morning was a very insightful Presidential Address by Dr. Andrew Walter! Not only is a he a very entertaining speaker but he also shed some light on 2 challenges that we currently face in the field. He eloquently stated that, “every woman who is a candidate for a vaginal hysterectomy should be able to get one and have it performed competently, and every woman who needs surgery should have one performed by someone who performs enough surgeries every year to competently perform the surgery.” He frequently alluded to the wise Dr. Mayo, who stated, “The best interest of the patient is the only interest to be considered…” Let’s never forget this as physicians!
Do you find removing the adnexa challenging when performing vaginal surgery? Check out the amazing idea from the Cleveland Clinic shown in video presentation 05! They clearly demonstrate using a single-site gel port or surgical glove placed in the vaginal incision to perform laparoscopy through the vagina. What a novel idea to avoid any abdominal incisions when there is a difficult vaginal adnexal surgery!
After the morning break, we watched a master vaginal surgeon perform a sacral colpopexy through the vaginal route. For details on this method, please reference video presentation 06.
An increase in health care costs is a huge problem in this country. Dr. Mary Van Meter suggested that one area in which we can improve is in the operating room (OR), specifically through decreasing the number of instruments sterilized. She found that only approximately 20% of the instruments on the operating field were actually used by the OR physician. It costs about $3 per instrument on the tray at Vanderbilt University, she said. When you think of the few number of instruments actually used, if we work to limit the number of instruments on the trays, we could cut significant costs. As reimbursement is getting increasingly linked to cost reduction, we all should be thinking about innovative ways to cut costs.
The oral posters were all excellent!
Dr. Ann Peters showed that, at a high-volume tertiary-care center, multimodal preoperative testing failed to definitively identify leiomyosarcoma (LMS), and the factors associated with increased LMS risk included older age, menopause, and presence of fibroids with concurrent pelvic, uterine, or adnexal mass.
Dr. Kevin Kremer found that preoperative antibiotics were used in 23% of cases in which they were not indicated, and the increased use rate was associated with entrance into the abdomen during surgery, the individual surgeon, and time under anesthesia.
Dr. Jessica Heft then stated that the incontinence rate after midurethral sling revision for vaginal exposure or pain was significantly higher with a partial as opposed to complete mesh excision.
Fecal incontinence treatment options
Dr. Peter Rosenblatt tackled the issue of “Innovation or experimentation: Where do we draw the line?” in the TeLinde lecture. He started by describing a condition for which he feels we do not have an acceptable amount of treatment options for patients: fecal incontinence. He described how he observed that the puborectalis muscle, not the external anal sphincter, was critical for fecal continence. He then devised a surgery that created a sling that would act as a synthetic puborectalis muscle. He had amazing success until one patient had a serious complication. Should you abandon a successful, innovative surgery due to one very severe complication, was the question. Where do we draw the line? I don’t have an answer…but I do know that we all need to thank our puborectalis muscle for our daily fecal continence!
This is not a new issue in medicine, explained Dr. Rosenblatt. From the beginning of medicine, there has been a balance between innovation and experimentation. So, what is innovation? It is when someone improves upon a device or process. In medicine, is it innovation or just variation? We frequently use medications and devices “off label,” and these techniques often improve our surgeries and outcomes for our patients. Innovation comes about through careful planning, a necessity created by an emergency, advances in technology, and through evolution of a procedure. Who are the innovators? YOU are! We are the ones who understand the unmet needs and the potential opportunities for improving medicine. Let’s all work together to innovate NOT experiment and make medicine better so our patients have the best care possible!
“New Frontiers in Gynecologic Surgery: Transgender Surgery and Functional Clitoroplasty after Female Genital Mutilation”
The final talk for the day was by the groundbreaking Dr. Marci Bowers, whose lecture started by reminding everyone that there is a difference between gender identity and gender expression. Once a person knows his or her gender identity they use gender expression to express this to the world, she pointed out. Dr. Bowers is a true innovator and is performing gender reassignment surgeries as well as female genital mutilation corrective surgeries. She has perfected a one-stage vaginoplasty, and she showed a video of the procedure, which results in a 90% chance of orgasm. She also noted that she is able to restore clitoral function in 100% of the cases of genital mutilation, and she performs these procedures free of charge.
She reminded us that all ObGyns need to be trained in treating transgender patients, and given the high rate of suicide among adolescent transgender individuals, we all need to work together to provide a supportive medical environment to help these patients. What a fascinating end to the day!
Some relaxation, and entertainment, amid the sun and outdoors
We then had the afternoon to compete in a golf tournament, explore the area on mountain bikes, or lounge by the pool. Regardless of the daytime activities, we all came back together for the great lip-synch competition! All 4 teams gave an impressive performance, but the team from Brown University went home with the win! Such an entertaining event! (Thanks to incoming SGS President Vivian Sung @wih_sung for the pic!)
4/11/16. DAY 2 AT SGS
Experts talk surgical innovations, complementary therapies, value-based payment, and much more at SGS day 2
Wake up and learn! The second day of the 42nd Annual Scientific Meeting of the Society of Gynecologic Surgeons began with a review of research posters at the Poster Session as the sun rose over the Palm Springs mountains. We then moved indoors for the scientific sessions.
In the first lecture, "Reasons for Unplanned 30-Day Readmission After Hysterectomy for Benign Disease," Dr. Courtney Penn and colleagues reiterated that the postsurgical readmission rate is higher for patients undergoing abdominal hysterectomy compared with those who have a laparoscopic or vaginal hysterectomy. Similarly, Dr. Jennifer Schmitt and colleagues suggested that in a patient with a relative contraindication for vaginal hysterectomy, when this procedure is performed by an experienced surgeon there may not be increased complications. However, keep in mind that the study described—"A Comparison of Vaginal and Robotic Hysterectomy for Commonly Cited Relative Contraindications to Vaginal Hysterectomy"—was performed at the Mayo Clinic by expert, highly trained surgeons, and this fact may limit the generalizability of the study. As one audience member eloquently stated, it is important to remember that: "Just because it is feasible does not mean it is the correct procedure."
That yoga or barre class may be doing more good than you think! Lunge, bridge, and cat-into-cow movements may provide a greater degree of pelvic floor muscle unit recruitment than traditional Kegel exercises, according to a presentation by Dr. Bruce Crawford on Kegels versus specialized movement.
Perhaps those exercises should be recommended for surgeons as well. As Dr. Ruchira Singh pointed out, surgeons experience a high amount of musculoskeletal strain when performing vaginal procedures while sitting, regardless of the type of chair used during surgery. Dr. Singh and colleagues’ study, "Effect of Different Chairs on Work-Related Musculoskeletal Discomfort During Vaginal Surgery," found that while the round stool with a backrest and the Capisco chair were more comfortable, they did not eliminate the high risk for musculoskeletal strain, particularly in the head and neck.
Dr. Ann Peters and colleagues, from Magee-Womens Hospital of the University of Pittsburgh Medical Center, gave a fabulous video presentation on "Anatomic and Vascular Considerations in Laparoscopic Uterine Artery Ligation During Hysterectomy."
Need a novel treatment for interstitial cystitis/bladder pain syndrome? Consider mindfulness-based stress reduction. A randomized controlled study performed by Dr. Gregg Kanter and colleagues describes how this technique may help patients and could be considered a first-line therapy.
What is value-based payment and this new trend in reimbursement? And how does it apply to vaginal hysterectomy? Dr. Tina Groat addressed these issues in her keynote lecture. According to the American Congress of Obstetricians and Gynecologists, “Evidence demonstrates that, in general, vaginal hysterectomy is associated with better outcomes and fewer complications than laparoscopic or abdominal hysterectomy.” This is in opposition to what is actually being performed clinically. Dr. Groat explained that United Healthcare decided to incentivize physicians by requiring a prior authorization for all hysterectomies for benign disease. There is both a quality and cost benefit to performing a vaginal hysterectomy. Most insurance companies are moving away from a “fee for service” structure to performance-based payment. Change is always scary and, while I think the overall goal of moving toward the best care for our patients is a positive, this approach may create new challenges for the medical field. What do you think? Is performance-based payment beneficial? Or does it limit physicians and potentially force them to perform a procedure they do not feel as comfortable performing? Will this result in physicians rejecting certain patient populations? [Note from OBG MANAGEMENT: Let Dr. Collins know your thoughts through social media, or email OBG MANAGEMENT with a Letter to the Editor (rbarbieri@frontlinemedcom.com).]
The debate on the best route for hysterectomy continues: According to Dr. Carolyn Swenson and colleagues in their presentation, "Comparison of Robotic and Other Minimally Invasive Routes of Hysterectomy for Benign Indications," while there may be lower complications associated with robotic hysterectomy, the cost of performing a robotic hysterectomy is significantly higher than the cost of laparoscopic or vaginal hysterectomy, thus limiting its utility.
How can we teach a rare surgical procedure to learners? We channel our inner Martha Stewart and make a model out of a beef tongue and chicken. For about $8 a challenging and rare surgery can be taught to residents and medical students, according to the video presentation by Dr. Jana Illston and colleagues, titled "Modified Beef Tongue Model for Fourth-Degree Laceration Repair Simulation."
After the Day 2 lunch break, there was a rousing debate surrounding "Surgeons as Innovators—What Is the Patient Expecting?" Where do we draw the line between using an older more proven therapy as opposed to trying an innovative technology that may actually offer a potential benefit? Dr. Dennis Miller made a good point regarding innovation and pharmaceutical and device companies: If we ignore industry, we lose the ability to help with innovation and shape the future of medical treatments. Perhaps we should use the golden rule: If we would perform the surgery or use the device on ourselves, then we should perform it on our patient. Patients have a greater burden now, because there are more treatment options that they must choose among. Our job as physicians is to educate our patients and to guide them to innovative and evidence-based treatments.
Highlights from the afternoon oral poster session included a presentation by Dr. Caryn Russman that noted the high risk for recurrent urinary tract infection (UTI) after a mid-urethral sling procedure, which seems to be related to specific preoperative risk factors (such as a history of recurrent UTI). Dr. Tanya Hoke suggested that residents and attending physicians have inaccurate estimates of uterine weight, and an educational program may be necessary to improve these estimates. Finally, a study from Massachusetts General Hospital showed that a shorter stay in the hospital, ideally same-day surgery, resulted in a lower complication risk, lower number of emergency department visits, and a decreased readmission rate for patients undergoing urogynecology procedures.
The following recommendations were then suggested regarding vaginal hysterectomy:
- Preoperative prep with 4% chlorhexidine or povidine iodine
- Intracervical vasopressin injection to decrease blood loss
- Use of a pedicle-sealing device for pedicle ligation
- Vertical cuff closure is preferred to maximize vaginal length
Another important point made was that a prior cesarean delivery is not a contraindication to performing a vaginal hysterectomy.
Recommendations regarding recurrent UTI were also made, which include the recommendation for preoperative use of antibiotics to decrease the rate of UTI, with no benefit for a longer course of antibiotics.
News from the Fellows’ Pelvic Research Network
So much exciting research currently is ongoing with the FPRN! New project ideas include comparison of trimethoprim with methenamie for treatment of recurrent UTI; comparison of laparoscopic/robotic sacrocolpopexy with vaginal USLS for management of apical prolapse; a survey study examining surgeon preferences for timing of midurethral sling placement when performed at the time of pelvic organ prolapse (POP) repair; an assessment of the effect of a midurethal sling on overactive bladder in surgical repair in POP; and a study evaluating female pelvic reconstructive surgery in the setting of human immunodeficiency virus infection. It is so great to see the fellows working together to provide groundbreaking research!
Fun with stats
Learning statistics at the end of the day is never easy, but Dr. Matthew Barber did a fabulous job explaining this often-confusing topic. He reminded attendees that the key to learning statistics is repetition. One new recommendation he offered to enhance understanding is to use common language instead of numbers for P values. For example, instead of saying P <.001, use “is superior,” and instead of saying P = .3, use “seems not superior” or “inconclusive.”
A night to remember
The night ended with a wonderful awards ceremony and the president’s reception. Overall, day 2 was a very educational—and fun—day!
4/10/16. DAY 1 AT SGS
Postgrad courses address pain management and social media education
Mastering pelvic pain
With the beautiful Palm Springs, California, backdrop of mountains and palm trees, the 2016 meeting of the Society of Gynecologic Surgeons kicked off with 4 postgraduate courses. At the “Mastering Pelvic Pain: Strategies and Techniques for a Multimodal Approach” course, directed by Dr. Cara King, Dr. Matt Siedhoff explained the key components of the history and physical examination: Keep in mind that this generally is a multifactorial issue and may require a multidisciplinary approach, he told attendees. It is also important to make sure that the patient is fully prepared to combat the chronic pelvic pain (CPP) symptoms by focusing on the fundamentals, he said, including smoking, diet, exercise, weight loss, sleep, and relationship stress.
How is your posture? It turns out that something as simple as altering your posture can significantly affect pelvic floor control. Carol Sobeck, PT, demonstrated this importance with a simple group exercise that proved how the ability to contract the pelvic floor changes significantly with posture. Get to know your pelvic floor physical therapist—they are critical in helping with the treatment of CPP.
But what to do when physical therapy fails? Dr. Jennifer Gunter shed some light on this very difficult medical situation. One suggestion, she said, is to consider the possibility of a local presentation of a systemic issue and screen for the following: fibromyalgia, Ehlers-Danlos syndrome, statin use, and diabetes mellitus. Other treatment ideas include trigger point injections and onabotulinumtoxin A (Botox) therapy. A trigger point is a hypercontracted focus of muscle. To treat a trigger point, a needle must mechanically disrupt the trigger point to reduce the pelvic pain, and injection of local anesthetic is only used to help with postprocedure discomfort. Botox in my pelvis, you ask? Yes! The goal is to block presynaptic release of acetylcholine, which is very effective at reducing muscle spasm.
Tackling endometriosis. Dr. King then described surgical techniques for endometriosis. She recommended that, for mild disease not in close proximity to vital structures, ablation is likely equivalent to excision. For deeply infiltrating endometriosis, or lesions in close proximity to vital structures, excision is more beneficial. Excision is always beneficial for pathologic diagnosis, she said. And she offered this tip for bladder endometriosis: place a stitch in the nodule to allow for counter traction. Here is another tip, for ovarian cystectomy: inject vasopressin (20 U in 60 mL) to help dissect the plane between the ovary and cyst wall, and consider presacral neurectomy for midline pain.
Dr. Frank Tu then explained that we should not think of it as the “terrible triad: endometriosis, irritable bowel syndrome, and interstitial cystsis,” but rather as a system out of balance. Both peripheral and central mechanisms are involved in the generation and maintenance of cross-organ sensitization, he pointed out, which may explain why patients receive multiple diagnoses that describe a myriad of complaints due to a lack of overall homeostasis.
While Dr. Alaa Abd-Elsayed described innovative nerve blocks for CPP, he emphasized that no one specific treatment will result in a complete resolution of symptoms.
Vaginal mesh placement and pain. Dr. Mario Castellanos gave a fabulous lecture describing the pain issues that surround vaginal mesh placement. Interestingly, he noted that many patients had pelvic pain prior to placement of vaginal mesh, and that pain likely only will worsen with mesh placement. Mesh may cause pain by causing inflammation, visceral injury, muscle injury, and nerve injury. While there are guidelines for where mesh should be placed for bladder slings (TVT and TOT) and for prolapse repair, studies show, he pointed out, that the mesh placement often disrupts several muscle groups and may directly injure a nerve.
Alternatives to the typical diagnoses for CPP. The morning ended with a lecture by Dr. Suzie As-Sanie, in which she reminded everyone to start with “gold standard” therapy but, if those fail, consider alternative diagnoses or a central pain disorder. She also suggested cognitive behavioral therapy for treatment of CPP. For patients who cannot afford cognitive behavioral therapy, there is a free online source at fibroguide.med.umich.edu. Other alternative treatment options include exercise, patient education, instruction on sleep hygiene, and neurostimulatory therapies.
Overall, all the speakers this morning agreed that CPP is rarely treated with one modality, and it is best treated with a multidisciplinary approach.
Let’s get social!
The afternoon was spent learning about ways to use social networking sites to educate our patients, in another postgraduate course on “Making Media Social,” presented by the SGS Social Media Committee. Given that a recent survey demonstrated that 74.1% of women have some type of social networking account, it can be a very useful source for medical information for patients. If you have any questions about what is appropriate on social media, check out ACOG committee opinion 622.
Here are some tips that I learned:
Facebook:
- Keep your private Facebook page private and create a separate professional Facebook page
- Adjust your login setting so only administrators can post on your professional page
- Adjust settings so your professional profile cannot be “tagged”
- If a patient contacts your personal page, direct them to your professional page
- Do not give medical advice since Facebook is not digitally encrypted
Twitter:
- “Short bursts of inconsequential information”
- Follow societies, medical centers, and medical journals
LinkedIn:
- It provides a great way to find jobs, people, and business opportunities that are recommended by someone in your contact group
- It is specifically there to help you grow your business and show people who you are and where you have come from
Doximity:
Before we get to tips, first, what is it? Well, Doximity is basically a “LinkedIn” for physicians. It is “a way to find relevant specialists for patients; a rolodex; an email and text service; and a virtual lounge.” It is currently transforming from social network into a ‘platform.’ Now more than 1,000 hospitals and health systems are part of Doximity. Tips:
- There is a secure message option, which is HIPAA compliant
- Provides a way for residents and fellows to understand possible future places of employment
- It is a great way to find someone to refer patients to in an unfamiliar location
Vimeo:
- A benefit over YouTube is the lack of advertisements
- Check out the SGS video archives!
- You also can set privacy settings and embedding stats
Fifty-nine percent of US adults have looked online for health information in the past year. Therefore, it is important for physicians to get good information out for people to see!
A relaxing day’s end
The night ended with a beautiful poolside reception! I can’t wait to see what day 2 will bring!
4/13/16. DAY 4 AT SGS
A jam-packed day of sessions, posters, awards, and clinical updates
Our last educational day was kicked off by a fascinating lecture by Dr. Amy Park on the “Genetic Determinants of Pelvic Organ Prolapse in Women of European American Descent: The Women’s Health Initiative.” Dr. Park and her colleagues found that there is evidence of phenotypic and genotypic heterogeneity in patients with pelvic organ prolapse, and there were 4 genetic loci identified that correlated with prolapse. Any uterine prolapse was associated with a genome-wide significant intergenic variant on chromosome 13, cystocele was associated with LOXL2, and all prolapse was associated with BMP.
Surmounting surgical site infection
Dr. Sarah Andiman then gave a lecture on the effects of a perioperative bundle and offered timely feedback for surgical site infection (SSI) prevention in hysterectomy. We all know that wound infections are a major morbidity associated with surgery, and Dr. Andiman’s group at Yale found that, by implementing this prevention program, the surgical site infection decreased 52.8%. Another suggestion from the audience was to have all patients use chlorhexidine wipes the night before and morning of a surgery to decrease wound infection. Similarly, Dr. Ali Bazzi gave a lecture on “Chlorhexidine-Alcohol Compared with Povidone-Iodine for Surgical-Site Antisepsis after Abdominal Hysterectomy.” The chlorhexidine was associated with 30% lower odds of SSI compared with povidone-iodine, even though this group had several medical comorbidities and risk factors known for SSIs.
Oral poster presenters make several interesting points
Dr. Christopher Ripperda from UT Southwestern Medical Center in Dallas, Texas, found that medical comorbidities and the presence of detrusor overactivity and PVR are predictors of early postoperative voiding dysfunction following a midurethral sling placement. Dr. Nabila Noor then described a fabulous surgical alternative to the use of morcellation to remove the uterus after a supracervical hysterectomy. She described the technique for performing a posterior colpotomy and stated that patients who had a surgery performed at her institution using this technique did not experience increased postoperative pain or longer postoperative stay.
Dr. Jennifer Thompson then shed some light on a very important question related to the Sunshine Act: Are physicians including all of their disclosures when they submit articles to a conference? When the physicians who submitted an abstract to the Society of Gynecologic Surgeons (SGS) in 2015 were searched on the Centers for Medicare and Medicaid Services (CMS) website, 62% of them had incomplete disclosures, with a total of nondisclosed CMS transactions equaling $1.3 million. We can do better!
Status update: The FPRN and passing of the torch
Congratulations to Dr. Kristin Jacobs, the new Fellows’ Pelvic Research Network (FPRN) Chair! The morning session ended with an innovative video from Dr. Janet Li and colleagues on the “Use of Suprapubic Carter-Thomason Needle to Assist in Cystoscopic Excision of Intravesical Foreign Object.”
The winner of the Distinguished Surgeon Award was given to Dr. Javier Magrina, and the SGS gavel was passed on to Dr. Vivian Sung! Congratulations!
Dr. Stephanie Pickett kicked off the eighth scientific session with a study entitled, “Comparing Methods of NSAID Delivery for Postoperative Pain.” When she and her colleagues compared IV toradol to IV ibuprofen for postoperative pain control after urogynecologic surgery, they found that patients experienced similar rates of pain control and satisfaction regardless of the type of analgesia.
Why are patients being readmitted after gynecologic oncology surgery?
The answer to this question is important as readmission rates are being considered for physician and hospital reimbursement. Dr. MaryAnn Wilbur and colleagues looked at the rates of unplanned 30-day readmission in gyn oncology patients. The patients who were readmitted had the following characteristics: ovarian cancer, creation of ostomy, Charleston score >5, language barrier, and positive discharge screen. Gastrointestinal disturbance and SSI were the most common reasons for readmission, and the total readmission-related costs for these patients was about $4.5 million.
Considering tissue extraction, surgical complications, and cognitive impairment
We then had 3 fabulous oral poster presentations. Dr. Emily Von Bargen and colleagues presented a study entitled, “Prevalence of Occult Pre-malignant or Malignant Pathology at the time of Uterine Morcellation for Benign Disease.” They performed a multicenter retrospective cohort study and found that 1.2% of women had a premalignant or malignant uterine pathology after surgery, with a prevalence of 0.66% of occult malignancy. She was unable to identify risk factors for those patients who had a premalignant or malignant pathology. Overall she found a low prevalence of premalignant or malignant uterine pathology when uterine morcellation was performed for benign disease.
Dr. Alix Leader-Cramer from Northwestern University pointed out “risk factors for a 30-day perioperative complications for total vaginal hysterectomy,” including chronic steroid use, higher ASA classification, current smoking status, diabetes, and lower preoperative serum albumin and sodium levels. Adnexectomy and resident participation were also associated with increased perioperative complications. About 9.5% of patients had a perioperative complication in the study population studied.
Finally, Dr. Elisa Trowbridge pointed out in her talk, on “Cognitive Impairment among Elderly Urogynecologic Patients,” that cognitive impairment is very prevalent among such women aged older than 75 years, and the Mini-Cog is a feasible screening tool.
What a way to end an AMAZING conference!
The conference ended with a fabulous video presentation by Dr. Andrea Benton, entitled “Surgical Approaches to the Management of Bladder and Ureteral Endometriosis.” Overall, the themes of this year’s SGS conference were to:
- emphasize the importance of performing a vaginal hysterectomy when feasible
- continue to strive to balance innovation with experimentation
- ensure that patients are being operated on by surgeons who are competent and frequently performing the indicated procedure.
Thank you to everyone who shared their research to educate the attendees at the conference! I can’t wait until next year!
4/12/16. DAY 3 AT SGS
Vaginal hysterectomy, fecal incontinence, transgender surgery amid tackled topics in Palm Springs
I could get used to sipping my coffee with the sunny background here in Palm Springs! It was a beautiful morning to learn.
We started the day with breakfast and a fabulous lecture on the inferior gluteal neurovascular anatomy in female cadavers, and an insightful lecture by Dr. Bhumy Dave, who brought up concerns about tracking for obstetrics and gynecology residency programs. She specifically highlighted the need for more experience with vaginal hysterectomies for residents who are going to be in a subspecialty that performs vaginal surgery. As the number of hysterectomies, specifically vaginal hysterectomies, declines every year, we need to make sure we are adequately training the physicians who will be performing this procedure in the future. One solution is to have residents join a track their 4th year of residency, after their future career path has been established. Another possible solution would be to increase use of a simulation model for vaginal hysterectomy, as described by Dr. Douglas Miyazaki.
Indigo carmine replacement? A recent issue in gynecologic surgery resulted when there was a national shortage of indigo carmine, which is commonly used to identify UO efflux at the time of cystoscopy. Dr. Katie Propst provided a solution: In the setting of planned cystoscopy, she found that preoperative phenazopyridine is an acceptable alternative and its use led to similar UO identification as with indigo carmine without an increase in complications.
Who should have a vaginal hysterectomy? Dr. Jennifer Schmitt from the Mayo Clinic gave another wonderful lecture describing a decision-tree algorithm for determining the ideal route of hysterectomy. According to a retrospective review of patients at their institution, vaginal hysterectomy was associated with lower infection rates, operative times, and costs.
The highlight of the morning was a very insightful Presidential Address by Dr. Andrew Walter! Not only is a he a very entertaining speaker but he also shed some light on 2 challenges that we currently face in the field. He eloquently stated that, “every woman who is a candidate for a vaginal hysterectomy should be able to get one and have it performed competently, and every woman who needs surgery should have one performed by someone who performs enough surgeries every year to competently perform the surgery.” He frequently alluded to the wise Dr. Mayo, who stated, “The best interest of the patient is the only interest to be considered…” Let’s never forget this as physicians!
Do you find removing the adnexa challenging when performing vaginal surgery? Check out the amazing idea from the Cleveland Clinic shown in video presentation 05! They clearly demonstrate using a single-site gel port or surgical glove placed in the vaginal incision to perform laparoscopy through the vagina. What a novel idea to avoid any abdominal incisions when there is a difficult vaginal adnexal surgery!
After the morning break, we watched a master vaginal surgeon perform a sacral colpopexy through the vaginal route. For details on this method, please reference video presentation 06.
An increase in health care costs is a huge problem in this country. Dr. Mary Van Meter suggested that one area in which we can improve is in the operating room (OR), specifically through decreasing the number of instruments sterilized. She found that only approximately 20% of the instruments on the operating field were actually used by the OR physician. It costs about $3 per instrument on the tray at Vanderbilt University, she said. When you think of the few number of instruments actually used, if we work to limit the number of instruments on the trays, we could cut significant costs. As reimbursement is getting increasingly linked to cost reduction, we all should be thinking about innovative ways to cut costs.
The oral posters were all excellent!
Dr. Ann Peters showed that, at a high-volume tertiary-care center, multimodal preoperative testing failed to definitively identify leiomyosarcoma (LMS), and the factors associated with increased LMS risk included older age, menopause, and presence of fibroids with concurrent pelvic, uterine, or adnexal mass.
Dr. Kevin Kremer found that preoperative antibiotics were used in 23% of cases in which they were not indicated, and the increased use rate was associated with entrance into the abdomen during surgery, the individual surgeon, and time under anesthesia.
Dr. Jessica Heft then stated that the incontinence rate after midurethral sling revision for vaginal exposure or pain was significantly higher with a partial as opposed to complete mesh excision.
Fecal incontinence treatment options
Dr. Peter Rosenblatt tackled the issue of “Innovation or experimentation: Where do we draw the line?” in the TeLinde lecture. He started by describing a condition for which he feels we do not have an acceptable amount of treatment options for patients: fecal incontinence. He described how he observed that the puborectalis muscle, not the external anal sphincter, was critical for fecal continence. He then devised a surgery that created a sling that would act as a synthetic puborectalis muscle. He had amazing success until one patient had a serious complication. Should you abandon a successful, innovative surgery due to one very severe complication, was the question. Where do we draw the line? I don’t have an answer…but I do know that we all need to thank our puborectalis muscle for our daily fecal continence!
This is not a new issue in medicine, explained Dr. Rosenblatt. From the beginning of medicine, there has been a balance between innovation and experimentation. So, what is innovation? It is when someone improves upon a device or process. In medicine, is it innovation or just variation? We frequently use medications and devices “off label,” and these techniques often improve our surgeries and outcomes for our patients. Innovation comes about through careful planning, a necessity created by an emergency, advances in technology, and through evolution of a procedure. Who are the innovators? YOU are! We are the ones who understand the unmet needs and the potential opportunities for improving medicine. Let’s all work together to innovate NOT experiment and make medicine better so our patients have the best care possible!
“New Frontiers in Gynecologic Surgery: Transgender Surgery and Functional Clitoroplasty after Female Genital Mutilation”
The final talk for the day was by the groundbreaking Dr. Marci Bowers, whose lecture started by reminding everyone that there is a difference between gender identity and gender expression. Once a person knows his or her gender identity they use gender expression to express this to the world, she pointed out. Dr. Bowers is a true innovator and is performing gender reassignment surgeries as well as female genital mutilation corrective surgeries. She has perfected a one-stage vaginoplasty, and she showed a video of the procedure, which results in a 90% chance of orgasm. She also noted that she is able to restore clitoral function in 100% of the cases of genital mutilation, and she performs these procedures free of charge.
She reminded us that all ObGyns need to be trained in treating transgender patients, and given the high rate of suicide among adolescent transgender individuals, we all need to work together to provide a supportive medical environment to help these patients. What a fascinating end to the day!
Some relaxation, and entertainment, amid the sun and outdoors
We then had the afternoon to compete in a golf tournament, explore the area on mountain bikes, or lounge by the pool. Regardless of the daytime activities, we all came back together for the great lip-synch competition! All 4 teams gave an impressive performance, but the team from Brown University went home with the win! Such an entertaining event! (Thanks to incoming SGS President Vivian Sung @wih_sung for the pic!)
4/11/16. DAY 2 AT SGS
Experts talk surgical innovations, complementary therapies, value-based payment, and much more at SGS day 2
Wake up and learn! The second day of the 42nd Annual Scientific Meeting of the Society of Gynecologic Surgeons began with a review of research posters at the Poster Session as the sun rose over the Palm Springs mountains. We then moved indoors for the scientific sessions.
In the first lecture, "Reasons for Unplanned 30-Day Readmission After Hysterectomy for Benign Disease," Dr. Courtney Penn and colleagues reiterated that the postsurgical readmission rate is higher for patients undergoing abdominal hysterectomy compared with those who have a laparoscopic or vaginal hysterectomy. Similarly, Dr. Jennifer Schmitt and colleagues suggested that in a patient with a relative contraindication for vaginal hysterectomy, when this procedure is performed by an experienced surgeon there may not be increased complications. However, keep in mind that the study described—"A Comparison of Vaginal and Robotic Hysterectomy for Commonly Cited Relative Contraindications to Vaginal Hysterectomy"—was performed at the Mayo Clinic by expert, highly trained surgeons, and this fact may limit the generalizability of the study. As one audience member eloquently stated, it is important to remember that: "Just because it is feasible does not mean it is the correct procedure."
That yoga or barre class may be doing more good than you think! Lunge, bridge, and cat-into-cow movements may provide a greater degree of pelvic floor muscle unit recruitment than traditional Kegel exercises, according to a presentation by Dr. Bruce Crawford on Kegels versus specialized movement.
Perhaps those exercises should be recommended for surgeons as well. As Dr. Ruchira Singh pointed out, surgeons experience a high amount of musculoskeletal strain when performing vaginal procedures while sitting, regardless of the type of chair used during surgery. Dr. Singh and colleagues’ study, "Effect of Different Chairs on Work-Related Musculoskeletal Discomfort During Vaginal Surgery," found that while the round stool with a backrest and the Capisco chair were more comfortable, they did not eliminate the high risk for musculoskeletal strain, particularly in the head and neck.
Dr. Ann Peters and colleagues, from Magee-Womens Hospital of the University of Pittsburgh Medical Center, gave a fabulous video presentation on "Anatomic and Vascular Considerations in Laparoscopic Uterine Artery Ligation During Hysterectomy."
Need a novel treatment for interstitial cystitis/bladder pain syndrome? Consider mindfulness-based stress reduction. A randomized controlled study performed by Dr. Gregg Kanter and colleagues describes how this technique may help patients and could be considered a first-line therapy.
What is value-based payment and this new trend in reimbursement? And how does it apply to vaginal hysterectomy? Dr. Tina Groat addressed these issues in her keynote lecture. According to the American Congress of Obstetricians and Gynecologists, “Evidence demonstrates that, in general, vaginal hysterectomy is associated with better outcomes and fewer complications than laparoscopic or abdominal hysterectomy.” This is in opposition to what is actually being performed clinically. Dr. Groat explained that United Healthcare decided to incentivize physicians by requiring a prior authorization for all hysterectomies for benign disease. There is both a quality and cost benefit to performing a vaginal hysterectomy. Most insurance companies are moving away from a “fee for service” structure to performance-based payment. Change is always scary and, while I think the overall goal of moving toward the best care for our patients is a positive, this approach may create new challenges for the medical field. What do you think? Is performance-based payment beneficial? Or does it limit physicians and potentially force them to perform a procedure they do not feel as comfortable performing? Will this result in physicians rejecting certain patient populations? [Note from OBG MANAGEMENT: Let Dr. Collins know your thoughts through social media, or email OBG MANAGEMENT with a Letter to the Editor (rbarbieri@frontlinemedcom.com).]
The debate on the best route for hysterectomy continues: According to Dr. Carolyn Swenson and colleagues in their presentation, "Comparison of Robotic and Other Minimally Invasive Routes of Hysterectomy for Benign Indications," while there may be lower complications associated with robotic hysterectomy, the cost of performing a robotic hysterectomy is significantly higher than the cost of laparoscopic or vaginal hysterectomy, thus limiting its utility.
How can we teach a rare surgical procedure to learners? We channel our inner Martha Stewart and make a model out of a beef tongue and chicken. For about $8 a challenging and rare surgery can be taught to residents and medical students, according to the video presentation by Dr. Jana Illston and colleagues, titled "Modified Beef Tongue Model for Fourth-Degree Laceration Repair Simulation."
After the Day 2 lunch break, there was a rousing debate surrounding "Surgeons as Innovators—What Is the Patient Expecting?" Where do we draw the line between using an older more proven therapy as opposed to trying an innovative technology that may actually offer a potential benefit? Dr. Dennis Miller made a good point regarding innovation and pharmaceutical and device companies: If we ignore industry, we lose the ability to help with innovation and shape the future of medical treatments. Perhaps we should use the golden rule: If we would perform the surgery or use the device on ourselves, then we should perform it on our patient. Patients have a greater burden now, because there are more treatment options that they must choose among. Our job as physicians is to educate our patients and to guide them to innovative and evidence-based treatments.
Highlights from the afternoon oral poster session included a presentation by Dr. Caryn Russman that noted the high risk for recurrent urinary tract infection (UTI) after a mid-urethral sling procedure, which seems to be related to specific preoperative risk factors (such as a history of recurrent UTI). Dr. Tanya Hoke suggested that residents and attending physicians have inaccurate estimates of uterine weight, and an educational program may be necessary to improve these estimates. Finally, a study from Massachusetts General Hospital showed that a shorter stay in the hospital, ideally same-day surgery, resulted in a lower complication risk, lower number of emergency department visits, and a decreased readmission rate for patients undergoing urogynecology procedures.
The following recommendations were then suggested regarding vaginal hysterectomy:
- Preoperative prep with 4% chlorhexidine or povidine iodine
- Intracervical vasopressin injection to decrease blood loss
- Use of a pedicle-sealing device for pedicle ligation
- Vertical cuff closure is preferred to maximize vaginal length
Another important point made was that a prior cesarean delivery is not a contraindication to performing a vaginal hysterectomy.
Recommendations regarding recurrent UTI were also made, which include the recommendation for preoperative use of antibiotics to decrease the rate of UTI, with no benefit for a longer course of antibiotics.
News from the Fellows’ Pelvic Research Network
So much exciting research currently is ongoing with the FPRN! New project ideas include comparison of trimethoprim with methenamie for treatment of recurrent UTI; comparison of laparoscopic/robotic sacrocolpopexy with vaginal USLS for management of apical prolapse; a survey study examining surgeon preferences for timing of midurethral sling placement when performed at the time of pelvic organ prolapse (POP) repair; an assessment of the effect of a midurethal sling on overactive bladder in surgical repair in POP; and a study evaluating female pelvic reconstructive surgery in the setting of human immunodeficiency virus infection. It is so great to see the fellows working together to provide groundbreaking research!
Fun with stats
Learning statistics at the end of the day is never easy, but Dr. Matthew Barber did a fabulous job explaining this often-confusing topic. He reminded attendees that the key to learning statistics is repetition. One new recommendation he offered to enhance understanding is to use common language instead of numbers for P values. For example, instead of saying P <.001, use “is superior,” and instead of saying P = .3, use “seems not superior” or “inconclusive.”
A night to remember
The night ended with a wonderful awards ceremony and the president’s reception. Overall, day 2 was a very educational—and fun—day!
4/10/16. DAY 1 AT SGS
Postgrad courses address pain management and social media education
Mastering pelvic pain
With the beautiful Palm Springs, California, backdrop of mountains and palm trees, the 2016 meeting of the Society of Gynecologic Surgeons kicked off with 4 postgraduate courses. At the “Mastering Pelvic Pain: Strategies and Techniques for a Multimodal Approach” course, directed by Dr. Cara King, Dr. Matt Siedhoff explained the key components of the history and physical examination: Keep in mind that this generally is a multifactorial issue and may require a multidisciplinary approach, he told attendees. It is also important to make sure that the patient is fully prepared to combat the chronic pelvic pain (CPP) symptoms by focusing on the fundamentals, he said, including smoking, diet, exercise, weight loss, sleep, and relationship stress.
How is your posture? It turns out that something as simple as altering your posture can significantly affect pelvic floor control. Carol Sobeck, PT, demonstrated this importance with a simple group exercise that proved how the ability to contract the pelvic floor changes significantly with posture. Get to know your pelvic floor physical therapist—they are critical in helping with the treatment of CPP.
But what to do when physical therapy fails? Dr. Jennifer Gunter shed some light on this very difficult medical situation. One suggestion, she said, is to consider the possibility of a local presentation of a systemic issue and screen for the following: fibromyalgia, Ehlers-Danlos syndrome, statin use, and diabetes mellitus. Other treatment ideas include trigger point injections and onabotulinumtoxin A (Botox) therapy. A trigger point is a hypercontracted focus of muscle. To treat a trigger point, a needle must mechanically disrupt the trigger point to reduce the pelvic pain, and injection of local anesthetic is only used to help with postprocedure discomfort. Botox in my pelvis, you ask? Yes! The goal is to block presynaptic release of acetylcholine, which is very effective at reducing muscle spasm.
Tackling endometriosis. Dr. King then described surgical techniques for endometriosis. She recommended that, for mild disease not in close proximity to vital structures, ablation is likely equivalent to excision. For deeply infiltrating endometriosis, or lesions in close proximity to vital structures, excision is more beneficial. Excision is always beneficial for pathologic diagnosis, she said. And she offered this tip for bladder endometriosis: place a stitch in the nodule to allow for counter traction. Here is another tip, for ovarian cystectomy: inject vasopressin (20 U in 60 mL) to help dissect the plane between the ovary and cyst wall, and consider presacral neurectomy for midline pain.
Dr. Frank Tu then explained that we should not think of it as the “terrible triad: endometriosis, irritable bowel syndrome, and interstitial cystsis,” but rather as a system out of balance. Both peripheral and central mechanisms are involved in the generation and maintenance of cross-organ sensitization, he pointed out, which may explain why patients receive multiple diagnoses that describe a myriad of complaints due to a lack of overall homeostasis.
While Dr. Alaa Abd-Elsayed described innovative nerve blocks for CPP, he emphasized that no one specific treatment will result in a complete resolution of symptoms.
Vaginal mesh placement and pain. Dr. Mario Castellanos gave a fabulous lecture describing the pain issues that surround vaginal mesh placement. Interestingly, he noted that many patients had pelvic pain prior to placement of vaginal mesh, and that pain likely only will worsen with mesh placement. Mesh may cause pain by causing inflammation, visceral injury, muscle injury, and nerve injury. While there are guidelines for where mesh should be placed for bladder slings (TVT and TOT) and for prolapse repair, studies show, he pointed out, that the mesh placement often disrupts several muscle groups and may directly injure a nerve.
Alternatives to the typical diagnoses for CPP. The morning ended with a lecture by Dr. Suzie As-Sanie, in which she reminded everyone to start with “gold standard” therapy but, if those fail, consider alternative diagnoses or a central pain disorder. She also suggested cognitive behavioral therapy for treatment of CPP. For patients who cannot afford cognitive behavioral therapy, there is a free online source at fibroguide.med.umich.edu. Other alternative treatment options include exercise, patient education, instruction on sleep hygiene, and neurostimulatory therapies.
Overall, all the speakers this morning agreed that CPP is rarely treated with one modality, and it is best treated with a multidisciplinary approach.
Let’s get social!
The afternoon was spent learning about ways to use social networking sites to educate our patients, in another postgraduate course on “Making Media Social,” presented by the SGS Social Media Committee. Given that a recent survey demonstrated that 74.1% of women have some type of social networking account, it can be a very useful source for medical information for patients. If you have any questions about what is appropriate on social media, check out ACOG committee opinion 622.
Here are some tips that I learned:
Facebook:
- Keep your private Facebook page private and create a separate professional Facebook page
- Adjust your login setting so only administrators can post on your professional page
- Adjust settings so your professional profile cannot be “tagged”
- If a patient contacts your personal page, direct them to your professional page
- Do not give medical advice since Facebook is not digitally encrypted
Twitter:
- “Short bursts of inconsequential information”
- Follow societies, medical centers, and medical journals
LinkedIn:
- It provides a great way to find jobs, people, and business opportunities that are recommended by someone in your contact group
- It is specifically there to help you grow your business and show people who you are and where you have come from
Doximity:
Before we get to tips, first, what is it? Well, Doximity is basically a “LinkedIn” for physicians. It is “a way to find relevant specialists for patients; a rolodex; an email and text service; and a virtual lounge.” It is currently transforming from social network into a ‘platform.’ Now more than 1,000 hospitals and health systems are part of Doximity. Tips:
- There is a secure message option, which is HIPAA compliant
- Provides a way for residents and fellows to understand possible future places of employment
- It is a great way to find someone to refer patients to in an unfamiliar location
Vimeo:
- A benefit over YouTube is the lack of advertisements
- Check out the SGS video archives!
- You also can set privacy settings and embedding stats
Fifty-nine percent of US adults have looked online for health information in the past year. Therefore, it is important for physicians to get good information out for people to see!
A relaxing day’s end
The night ended with a beautiful poolside reception! I can’t wait to see what day 2 will bring!
Robot-assisted laparoscopic myomectomy
The management of symptomatic uterine fibroids in the patient desiring conservative surgical therapy can be challenging at times. The advent of robot-assisted laparoscopy has provided surgeons with an enabling tool and patients with the option for a minimally invasive approach to myomectomy.
This month’s video was produced in order to demonstrate a systematic approach to the robot-assisted laparoscopic myomectomy in patients who are candidates. The example case is removal of a 5-cm, intrauterine posterior myoma in a 39-year-old woman (G3P1021) with heavy menstrual bleeding who desires future fertility.
Key objectives of the video include:
- understanding the role of radiologic imaging as part of preoperative surgical planning
- recognizing the key robotic instruments and suture selected to perform the procedure
- discussing robot-specific techniques that facilitate fibroid enucleation and hysterotomy repair.
Also integrated into this video is the application of the ExCITE technique—a manual cold knife tissue extraction technique utilizing an extracorporeal semi-circle “C-incision” approach—for tissue extraction. This technique was featured in an earlier installment of the video channel.1
I hope that you find this month’s video helpful to your surgical practice.

Share your thoughts on this video! Send your Letter to the Editor to rbarbieri@frontlinemedcom.com. Please include your name and the city and state in which you practice.
- Truong M, Advincula A. Minimally invasive tissue extraction made simple: the Extracorporeal C-Incision Tissue Extraction (ExCITE) technique. OBG Manag. 2014;26(11):56.
The management of symptomatic uterine fibroids in the patient desiring conservative surgical therapy can be challenging at times. The advent of robot-assisted laparoscopy has provided surgeons with an enabling tool and patients with the option for a minimally invasive approach to myomectomy.
This month’s video was produced in order to demonstrate a systematic approach to the robot-assisted laparoscopic myomectomy in patients who are candidates. The example case is removal of a 5-cm, intrauterine posterior myoma in a 39-year-old woman (G3P1021) with heavy menstrual bleeding who desires future fertility.
Key objectives of the video include:
- understanding the role of radiologic imaging as part of preoperative surgical planning
- recognizing the key robotic instruments and suture selected to perform the procedure
- discussing robot-specific techniques that facilitate fibroid enucleation and hysterotomy repair.
Also integrated into this video is the application of the ExCITE technique—a manual cold knife tissue extraction technique utilizing an extracorporeal semi-circle “C-incision” approach—for tissue extraction. This technique was featured in an earlier installment of the video channel.1
I hope that you find this month’s video helpful to your surgical practice.

Share your thoughts on this video! Send your Letter to the Editor to rbarbieri@frontlinemedcom.com. Please include your name and the city and state in which you practice.
The management of symptomatic uterine fibroids in the patient desiring conservative surgical therapy can be challenging at times. The advent of robot-assisted laparoscopy has provided surgeons with an enabling tool and patients with the option for a minimally invasive approach to myomectomy.
This month’s video was produced in order to demonstrate a systematic approach to the robot-assisted laparoscopic myomectomy in patients who are candidates. The example case is removal of a 5-cm, intrauterine posterior myoma in a 39-year-old woman (G3P1021) with heavy menstrual bleeding who desires future fertility.
Key objectives of the video include:
- understanding the role of radiologic imaging as part of preoperative surgical planning
- recognizing the key robotic instruments and suture selected to perform the procedure
- discussing robot-specific techniques that facilitate fibroid enucleation and hysterotomy repair.
Also integrated into this video is the application of the ExCITE technique—a manual cold knife tissue extraction technique utilizing an extracorporeal semi-circle “C-incision” approach—for tissue extraction. This technique was featured in an earlier installment of the video channel.1
I hope that you find this month’s video helpful to your surgical practice.

Share your thoughts on this video! Send your Letter to the Editor to rbarbieri@frontlinemedcom.com. Please include your name and the city and state in which you practice.
- Truong M, Advincula A. Minimally invasive tissue extraction made simple: the Extracorporeal C-Incision Tissue Extraction (ExCITE) technique. OBG Manag. 2014;26(11):56.
- Truong M, Advincula A. Minimally invasive tissue extraction made simple: the Extracorporeal C-Incision Tissue Extraction (ExCITE) technique. OBG Manag. 2014;26(11):56.
2016 Update on minimally invasive gynecologic surgery
Rightly so, the topics of mechanical tissue extraction and hysterectomy approach have dominated the field of obstetrics and gynecology over the past 12 months and more. A profusion of literature has been published on these subjects. However, there are 2 important topics within the field of minimally invasive gynecologic surgery that deserve our attention as well, and I have chosen to focus on these for this Update.
First, laparoscopic treatment of ovarian endometriomas is one of the most commonly performed gynecologic procedures worldwide. Many women undergoing such surgery are of childbearing age and have the desire for future pregnancy. What are best practices for preserving ovarian function in these women? Two studies recently published in the Journal of Minimally Invasive Gynecology addressed this question.
Second, until recently, the rate of bowel injury at laparoscopic gynecologic surgery has not been well established.1 Moreover, mechanical bowel preparation is commonly employed in case intestinal injury does occur, despite the lack of evidence that outcomes of these possible injuries can be improved.2 Understanding the rate of bowel injury can shed light on the overall value of the perceived benefits of bowel preparation. Therefore, I examine 2 recent systematic reviews that analyze the incidence of bowel injury and the value of bowel prep in gynecologic laparoscopic surgery.
bipolar coagulation inferior to suturing or hemostatic sealant for preserving ovarian function
Song T, Kim WY, Lee KW, Kim KH. Effect on ovarian reserve of hemostasis by bipolar coagulation versus suture during laparoendoscopic single-site cystectomy for ovarian endometriomas. J Minim Invasive Gynecol. 2015;22(3):415−420.
Ata B, Turkgeldi E, Seyhan A, Urman B. Effect of hemostatic method on ovarian reserve following laparoscopic endometrioma excision; comparison of suture, hemostatic sealant, and bipolar dessication. A systematic review and meta-analysis. J Minim Invasive Gynecol. 2015;22(3):363−372.
The customary surgical approach for laparoscopic cystectomy is by mechanical stripping of the cyst wall (FIGURE) and the use of bipolar desiccation for hemostasis. Stripping inevitably leads to removal of healthy ovarian cortex,3 especially in inexperienced hands,4 and ovarian follicles inevitably are destroyed during electrosurgical desiccation. When compared with the use of suturing or a hemostatic agent to control bleeding in the ovarian defect, the use of bipolar electrosurgery may harm more of the ovarian cortex, resulting in a comparatively diminished follicular cohort.
Possible deleterious effects on the ovarian reserve can be determined with a blood test to measure anti-Müllerian hormone (AMH) levels postoperatively. Produced by the granulosa cells of the ovary, this hormone directly reflects the remaining ovarian egg supply. Lower levels of AMH have been shown to significantly decrease the success rate of in vitro fertilization (IVF), especially in women older than age 35.5 Moreover, AMH levels in the late reproductive years can be used as a predictive marker of menopause, with lower levels predicting significantly earlier onset.6
Data from 2 recent studies, a quasi-randomized trial by Song and colleagues and a systematic review and meta-analysis by Ata and colleagues emphasize that bipolar desiccation for hemostasis may not be best practice for protecting ovarian reserve during laparoscopic ovarian cystectomy for an endometrioma.
AMH levels decline more significantly for women undergoing bipolar desiccation
Song and colleagues conducted a prospective quasi-randomized study of 125 women whose endometriomas were laparoscopically removed via a single-site approach and managed for hemostasis with either bipolar desiccation or suturing of the ovarian defect with a 2-0 barbed suture. All surgeries were conducted by a single surgeon.
At 3 months postsurgery, mean AMH levels had declined from baseline by 42.2% (interquartile range [IR], 16.5−53.0 ng/mL) in the desiccation group and by 24.6% (IR, 11.6−37.0 ng/mL) in the suture group (P = .001). Multivariate analysis showed that the method used for hemostasis was the only determinant for reduced ovarian reserve.
In their systematic review and meta-analysis, Ata and colleagues included 10 studies--6 qualitative and 4 quantitative. All studies examined the rate of change of serum AMH levels 3 months after laparoscopic removal of an endometrioma.
In their qualitative analysis, 5 of the 6 studies reported a significantly greater decrease in ovarian reserve after bipolar desiccation (varying from 13% to 44%) or a strong trend in the same direction. In the sixth study, the desiccation group had a lower decline in absolute AMH level than in the other 5 studies. The authors note that this 2.7% decline was much lower than the values reported for the bipolar desiccation group of any other study. (Those declines ranged between 19% and 58%.)
Although not significant, in all 3 of the included randomized controlled trials (RCTs), the desiccation groups had a greater loss in AMH level than the hemostatic sealant groups, and in 2 of these RCTs, bipolar desiccation groups had a greater loss than the suturing groups.
Among the 213 study participants in the 3 RCTs and the prospective cohort study included in the quantitative meta-analysis, alternative methods to bipolar desiccation were associated with a 6.95% lower decrease in AMH-level decline (95% confidence interval [CI], −13.0% to −0.9%; P = .02).
What this EVIDENCE means for practice
Compared with the use of bipolar electrosurgery to attain hemostasis, the use of a topical biosurgical agent or suturing could be significantly better for protection of the ovarian follicles during laparoscopic ovarian cystectomy for endometrioma. These alternative methods especially could benefit those women desiring future pregnancy who are demonstrated preoperatively to have a low ovarian reserve. As needed, electrosurgery should be sparingly employed for ovarian hemostasis.
Large Study identifies incidence of bowel injury during gynecologic laproscopy
Llarena NC, Shah AB, Milad MP. Bowel injury in gynecologic laparoscopy: a systematic review. Am J Obstet Gynecol. 2015;125(6):1407−1417.
In no aspect of laparoscopic surgery are preventive strategies more cautiously employed than during peritoneal access. Regardless of the applied technique, there is an irreducible risk of injury to the underlying viscera by either adhesions between the underlying bowel and abdominal wall or during the course of pilot error. Moreover, in the best of hands, bowel injury can occur whenever normal anatomic relationships need to be restored using intra-abdominal adhesiolysis. Given the ubiquity, these risks are never out of the surgeon's mind. Gynecologists are obliged to discuss these risks during the informed consent process.
Until recently, the rate of bowel injury has not been well established. Llarena and colleagues recently have conducted the largest systematic review of the medical literature to date for incidence, presentation, mortality, cause, and location of bowel injury associated with laparoscopic surgery while not necessarily distinguishing for the type of bowel injury. Sixty retrospective and 27 prospective studies met inclusion criteria.
The risk of bowel injury overall and defined
Among 474,063 laparoscopic surgeries conducted between 1972 and 2014, 604 bowel injuries were found, for an incidence of 1 in 769, or 0.13% (95% CI, 0.12−0.14%).
The rate of bowel injury varied by procedure, year, study type, and definition of bowel injury. The incidence of injury according to:
- definition, was 1 in 416 (0.24%) for studies that clearly included serosal injuries and enterotomies versus 1 in 833 (0.12%) for studies not clearly defining the type of bowel injury (relative risk [RR], 0.47; 95% CI, 0.38−0.59; P<.001)
- study type, was 1 in 666 (0.15%) for prospective studies versus 1 in 909 (0.11%) for retrospective studies (RR, 0.78; 95% CI, 0.63−0.96; P = .02)
- procedure, was 1 in 3,333 (0.03%; 95% CI, 0.01−0.03%) for sterilization and 1 in 256 (0.39%; 95% CI, 0.35−0.45%) for hysterectomy
- year, for laparoscopic hysterectomy only, was 1 in 222 (0.45%) before the year 2000 and 1 in 294 (0.34%) after 2000 (RR, 0.75; 95% CI, 0.57−0.98; P = .03).
How were injuries caused, found, and managed?
Thirty studies described the laparoscopic instrument used during 366 reported bowel injuries. The majority of injuries (55%) occurred during initial peritoneal access, with the Veress needle or trocar causing the damage. This was followed by electrosurgery (29%), dissection (11%), and forceps or scissors (4.1%).
According to 40 studies describing 307 injuries, bowel injuries most often were managed by converting to laparotomy (80%); only 8% of injuries were managed with laparoscopy and 2% expectantly.
Surgery to repair the bowel injury was delayed in 154 (41%) of 375 cases. The median time to injury discovery was 3 days (range, 1−13 days).
In only 19 cases were the presenting signs and symptoms of bowel injury recorded. Those reported from most to least often were: peritonitis, abdominal pain, fever, abdominal distention, leukocytosis, leukopenia, and septic shock.
Mortality
Mortality as an outcome was only reported in 29 of the total 90 studies; therefore, mortality may be underreported. Overall, however, death occurred in 1 (0.8%) of 125 bowel injuries.
The overall mortality rate from bowel injury--calculated from the only 42 studies that explicitly mentioned mortality as an outcome--was 1 in 125, or 0.8% (95% CI, 0.36%-1.9%). All 5 reported deaths occurred as a result of delayed recognition of bowel injury, which made the mortality rate for unrecognized bowel injury 1 in 31, or 3.2% (95% CI, 1%-7%). No deaths occurred when the bowel injury was noted intraoperatively.
What this EVIDENCE means for practice
In this review of 474,063 laparoscopic procedures, bowel injury occurred in 1 in 769, or 0.13% of procedures. Bowel injury is more apt to occur during more complicated laparoscopic procedures (compared with laparoscopic sterilization procedures, the risk during hysterectomy was greater than 10-fold).
Most of the injuries were managed by laparotomic surgery despite the potential to repair bowel injury by laparoscopy. Validating that peritoneal access is a high risk part of laparoscopic surgery, the majority of the injuries occurred during insufflation with a Veress needle or during abdominal access by trocar insertion. Nearly one-third of the injuries were from the use of electrosurgery, which are typically associated with a delay in presentation.
In this study, 41% of the injuries were unrecognized at the time of surgery. All 5 of the reported deaths were associated with a delay in diagnosis, with an overall mortality rate of 1 of 125, or 0.8%. Since all of these deaths were associated with a delay in diagnosis, the rate of mortality in unrecognized bowel injury was 5 of 154, or 3.2%. Among women who experienced delayed diagnosis, only 19 of 154 experienced signs or symptoms diagnostic for an underlying bowel injury, particularly when the small bowel was injured.
Can mechanical bowel prep positively affect outcomes in gynecologic laparoscopy, or should it be discarded?
Arnold A, Aitchison LP, Abbott J. Preoperative mechanical bowel preparation for abdominal, laparoscopic, and vaginal surgery: a systematic review. J Minim Invasive Gynecol. 2015;22(5):737−752.
Popularized for more than 4 decades, the practice of presurgical bowel preparation is predicated on the notion that the presence of less, versus more, feces can minimize bacterial count and thereby reduce peritoneal contamination. Logically then, surgical site infections (SSIs) should be reduced with bowel preparation. Moreover, the surgical view and bowel handling during laparoscopic surgery should be improved, with surgical times consequently reduced.
Surgeons must weigh the putative benefits of mechanical bowel preparation against the unpleasant experience it causes for patients, as well as the risks of dehydration or electrolyte disturbance it may cause. To this day, a considerable percentage of gynecologists and colorectal surgeons routinely prep the bowel after weighing all of these factors, despite the paucity of evidence for the practice's efficacy to reduce SSI and improve surgical outcomes.7
The results of this recent systematic review critically question the usefulness of preoperative bowel preparation for abdominal, laparoscopic, and vaginal surgery.
Details of the analysis
The authors evaluated high-quality studies on mechanical bowel preparation to assess evidence for:
- surgeon outcomes, including the surgical field and bowel handling
- operative outcomes, including intraoperative complications and operative times
- patient outcomes, including postoperative complications, overall morbidity, and length of stay.
The authors identified RCTs and prospective or retrospective cohort studies in various surgical specialties comparing preoperative bowel preparation to no such prep. Forty-three studies met inclusion criteria: 38 compared prep to no prep, and 5 compared prep to a single rectal enema. Five high-grade studies in gynecology were included (n = 795), with 4 of them RCTs of gynecologic laparoscopy (n = 645).
Operative field and duration
Of the studies comparing bowel prep with no prep, only the 5 gynecologic ones assessed operative field. Surgical view was perceived as improved in only 1 study. In another, surgeons only could guess allocation half the time.
Sixteen studies evaluated impact of mechanical bowel preparation on duration of surgery: 1 high-quality study found a significant reduction in OR time with bowel prep, and 1 moderate-quality study found longer operative time with bowel prep.
Patient outcomes
Of all studies assessing patient outcomes, 3 high-quality studies of colorectal patients (n = 490) found increased complications from prep versus no prep, including anastomotic dehiscence (P = .05), abdominal complications (P = .028), and infectious complications (P = .05).
Length of stay was assessed in 26 studies, with 4 reporting longer hospital stay with bowel prep and the remaining finding no difference between prep and no prep.
Across all specialties, only 2 studies reported improved outcomes with mechanical bowel preparation. One was a high-quality study reporting reduced 30-day morbidity (P = .018) and infectious complication rates (P = .018), and the other was a moderate-quality study that found reduced SSI (P = .0001) and organ space infection (P = .024) in patients undergoing bowel prep.
Mechanical bowel preparation vs enema
Bowel prep was compared with a single rectal enema in 5 studies. In 2 of these, patient outcomes were worse with enema. One high-quality study of 294 patients reported increased intra-abdominal fecal soiling (P = .008) in the enema group. (The surgeons believed that bowel preparation was more likely to be inadequate in this group, 25% compared with 6%, P<.05.) Whereas there was no statistical difference in the incidence of anastomotic leak between these groups, there was higher reoperation rate in the enema-only group where leakage was diagnosed (6 [4.1%] vs 0, respectively; P = .013).
Bowel prep and preoperative and postoperative symptoms
Six high-quality studies reported on the impact of mechanical bowel preparation on patient symptoms, such as nausea, weakness, abdominal distention, and satisfaction before and after surgery. In all but 1 study patients had significantly greater discomfort with bowel preparation. In 2 of the 6 studies, patients had more diarrhea (P = .0003), a delay in the first bowel movement (P = .001), and a slower return to normal diet (P = .004).
What this EVIDENCE means for practice
The theory behind mechanical bowel preparation is not supported by the evidence. Despite the fact that the bowel is not customarily entered, up to 50% of gynecologic surgeons employ bowel preparation, with the hope of improving visualization and decreasing risk of an anastomotic leak. The colorectal studies in this review demonstrate no evidence for decreased anastomotic leak or infectious complications. By extrapolation, there is no evidence that using preoperative bowel prep bestows any benefit if bowel injury occurs inadvertently and if resection or reanastomosis is then required.
Among the 7 studies examining bowel prep in laparoscopy (4 gynecology, 3 urology, and 1 colorectal), only data from 1 demonstrated an improved surgical field (and in this case only by 1 out of 10 on a Likert scale). The impact of mechanical bowel preparation on the visual field is the same for diagnostic or complex laparoscopic surgeries. One high-quality study with deep endometriosis resection demonstrated no change in the operative field as reflected by no practical differences in OR time or complications.
Preparing the bowel for surgery is an intrusive process that reduces patient satisfaction by inducing weakness, abdominal distention, nausea, vomiting, hunger, and thirst. Whereas this systematic analysis failed to confirm any benefit of the process, it provides evidence for the potential for harm. Mechanical bowel preparation should be discarded as a routine preoperative treatment for patients undergoing minimally invasive gynecologic surgery.
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.
Rightly so, the topics of mechanical tissue extraction and hysterectomy approach have dominated the field of obstetrics and gynecology over the past 12 months and more. A profusion of literature has been published on these subjects. However, there are 2 important topics within the field of minimally invasive gynecologic surgery that deserve our attention as well, and I have chosen to focus on these for this Update.
First, laparoscopic treatment of ovarian endometriomas is one of the most commonly performed gynecologic procedures worldwide. Many women undergoing such surgery are of childbearing age and have the desire for future pregnancy. What are best practices for preserving ovarian function in these women? Two studies recently published in the Journal of Minimally Invasive Gynecology addressed this question.
Second, until recently, the rate of bowel injury at laparoscopic gynecologic surgery has not been well established.1 Moreover, mechanical bowel preparation is commonly employed in case intestinal injury does occur, despite the lack of evidence that outcomes of these possible injuries can be improved.2 Understanding the rate of bowel injury can shed light on the overall value of the perceived benefits of bowel preparation. Therefore, I examine 2 recent systematic reviews that analyze the incidence of bowel injury and the value of bowel prep in gynecologic laparoscopic surgery.
bipolar coagulation inferior to suturing or hemostatic sealant for preserving ovarian function
Song T, Kim WY, Lee KW, Kim KH. Effect on ovarian reserve of hemostasis by bipolar coagulation versus suture during laparoendoscopic single-site cystectomy for ovarian endometriomas. J Minim Invasive Gynecol. 2015;22(3):415−420.
Ata B, Turkgeldi E, Seyhan A, Urman B. Effect of hemostatic method on ovarian reserve following laparoscopic endometrioma excision; comparison of suture, hemostatic sealant, and bipolar dessication. A systematic review and meta-analysis. J Minim Invasive Gynecol. 2015;22(3):363−372.
The customary surgical approach for laparoscopic cystectomy is by mechanical stripping of the cyst wall (FIGURE) and the use of bipolar desiccation for hemostasis. Stripping inevitably leads to removal of healthy ovarian cortex,3 especially in inexperienced hands,4 and ovarian follicles inevitably are destroyed during electrosurgical desiccation. When compared with the use of suturing or a hemostatic agent to control bleeding in the ovarian defect, the use of bipolar electrosurgery may harm more of the ovarian cortex, resulting in a comparatively diminished follicular cohort.
Possible deleterious effects on the ovarian reserve can be determined with a blood test to measure anti-Müllerian hormone (AMH) levels postoperatively. Produced by the granulosa cells of the ovary, this hormone directly reflects the remaining ovarian egg supply. Lower levels of AMH have been shown to significantly decrease the success rate of in vitro fertilization (IVF), especially in women older than age 35.5 Moreover, AMH levels in the late reproductive years can be used as a predictive marker of menopause, with lower levels predicting significantly earlier onset.6
Data from 2 recent studies, a quasi-randomized trial by Song and colleagues and a systematic review and meta-analysis by Ata and colleagues emphasize that bipolar desiccation for hemostasis may not be best practice for protecting ovarian reserve during laparoscopic ovarian cystectomy for an endometrioma.
AMH levels decline more significantly for women undergoing bipolar desiccation
Song and colleagues conducted a prospective quasi-randomized study of 125 women whose endometriomas were laparoscopically removed via a single-site approach and managed for hemostasis with either bipolar desiccation or suturing of the ovarian defect with a 2-0 barbed suture. All surgeries were conducted by a single surgeon.
At 3 months postsurgery, mean AMH levels had declined from baseline by 42.2% (interquartile range [IR], 16.5−53.0 ng/mL) in the desiccation group and by 24.6% (IR, 11.6−37.0 ng/mL) in the suture group (P = .001). Multivariate analysis showed that the method used for hemostasis was the only determinant for reduced ovarian reserve.
In their systematic review and meta-analysis, Ata and colleagues included 10 studies--6 qualitative and 4 quantitative. All studies examined the rate of change of serum AMH levels 3 months after laparoscopic removal of an endometrioma.
In their qualitative analysis, 5 of the 6 studies reported a significantly greater decrease in ovarian reserve after bipolar desiccation (varying from 13% to 44%) or a strong trend in the same direction. In the sixth study, the desiccation group had a lower decline in absolute AMH level than in the other 5 studies. The authors note that this 2.7% decline was much lower than the values reported for the bipolar desiccation group of any other study. (Those declines ranged between 19% and 58%.)
Although not significant, in all 3 of the included randomized controlled trials (RCTs), the desiccation groups had a greater loss in AMH level than the hemostatic sealant groups, and in 2 of these RCTs, bipolar desiccation groups had a greater loss than the suturing groups.
Among the 213 study participants in the 3 RCTs and the prospective cohort study included in the quantitative meta-analysis, alternative methods to bipolar desiccation were associated with a 6.95% lower decrease in AMH-level decline (95% confidence interval [CI], −13.0% to −0.9%; P = .02).
What this EVIDENCE means for practice
Compared with the use of bipolar electrosurgery to attain hemostasis, the use of a topical biosurgical agent or suturing could be significantly better for protection of the ovarian follicles during laparoscopic ovarian cystectomy for endometrioma. These alternative methods especially could benefit those women desiring future pregnancy who are demonstrated preoperatively to have a low ovarian reserve. As needed, electrosurgery should be sparingly employed for ovarian hemostasis.
Large Study identifies incidence of bowel injury during gynecologic laproscopy
Llarena NC, Shah AB, Milad MP. Bowel injury in gynecologic laparoscopy: a systematic review. Am J Obstet Gynecol. 2015;125(6):1407−1417.
In no aspect of laparoscopic surgery are preventive strategies more cautiously employed than during peritoneal access. Regardless of the applied technique, there is an irreducible risk of injury to the underlying viscera by either adhesions between the underlying bowel and abdominal wall or during the course of pilot error. Moreover, in the best of hands, bowel injury can occur whenever normal anatomic relationships need to be restored using intra-abdominal adhesiolysis. Given the ubiquity, these risks are never out of the surgeon's mind. Gynecologists are obliged to discuss these risks during the informed consent process.
Until recently, the rate of bowel injury has not been well established. Llarena and colleagues recently have conducted the largest systematic review of the medical literature to date for incidence, presentation, mortality, cause, and location of bowel injury associated with laparoscopic surgery while not necessarily distinguishing for the type of bowel injury. Sixty retrospective and 27 prospective studies met inclusion criteria.
The risk of bowel injury overall and defined
Among 474,063 laparoscopic surgeries conducted between 1972 and 2014, 604 bowel injuries were found, for an incidence of 1 in 769, or 0.13% (95% CI, 0.12−0.14%).
The rate of bowel injury varied by procedure, year, study type, and definition of bowel injury. The incidence of injury according to:
- definition, was 1 in 416 (0.24%) for studies that clearly included serosal injuries and enterotomies versus 1 in 833 (0.12%) for studies not clearly defining the type of bowel injury (relative risk [RR], 0.47; 95% CI, 0.38−0.59; P<.001)
- study type, was 1 in 666 (0.15%) for prospective studies versus 1 in 909 (0.11%) for retrospective studies (RR, 0.78; 95% CI, 0.63−0.96; P = .02)
- procedure, was 1 in 3,333 (0.03%; 95% CI, 0.01−0.03%) for sterilization and 1 in 256 (0.39%; 95% CI, 0.35−0.45%) for hysterectomy
- year, for laparoscopic hysterectomy only, was 1 in 222 (0.45%) before the year 2000 and 1 in 294 (0.34%) after 2000 (RR, 0.75; 95% CI, 0.57−0.98; P = .03).
How were injuries caused, found, and managed?
Thirty studies described the laparoscopic instrument used during 366 reported bowel injuries. The majority of injuries (55%) occurred during initial peritoneal access, with the Veress needle or trocar causing the damage. This was followed by electrosurgery (29%), dissection (11%), and forceps or scissors (4.1%).
According to 40 studies describing 307 injuries, bowel injuries most often were managed by converting to laparotomy (80%); only 8% of injuries were managed with laparoscopy and 2% expectantly.
Surgery to repair the bowel injury was delayed in 154 (41%) of 375 cases. The median time to injury discovery was 3 days (range, 1−13 days).
In only 19 cases were the presenting signs and symptoms of bowel injury recorded. Those reported from most to least often were: peritonitis, abdominal pain, fever, abdominal distention, leukocytosis, leukopenia, and septic shock.
Mortality
Mortality as an outcome was only reported in 29 of the total 90 studies; therefore, mortality may be underreported. Overall, however, death occurred in 1 (0.8%) of 125 bowel injuries.
The overall mortality rate from bowel injury--calculated from the only 42 studies that explicitly mentioned mortality as an outcome--was 1 in 125, or 0.8% (95% CI, 0.36%-1.9%). All 5 reported deaths occurred as a result of delayed recognition of bowel injury, which made the mortality rate for unrecognized bowel injury 1 in 31, or 3.2% (95% CI, 1%-7%). No deaths occurred when the bowel injury was noted intraoperatively.
What this EVIDENCE means for practice
In this review of 474,063 laparoscopic procedures, bowel injury occurred in 1 in 769, or 0.13% of procedures. Bowel injury is more apt to occur during more complicated laparoscopic procedures (compared with laparoscopic sterilization procedures, the risk during hysterectomy was greater than 10-fold).
Most of the injuries were managed by laparotomic surgery despite the potential to repair bowel injury by laparoscopy. Validating that peritoneal access is a high risk part of laparoscopic surgery, the majority of the injuries occurred during insufflation with a Veress needle or during abdominal access by trocar insertion. Nearly one-third of the injuries were from the use of electrosurgery, which are typically associated with a delay in presentation.
In this study, 41% of the injuries were unrecognized at the time of surgery. All 5 of the reported deaths were associated with a delay in diagnosis, with an overall mortality rate of 1 of 125, or 0.8%. Since all of these deaths were associated with a delay in diagnosis, the rate of mortality in unrecognized bowel injury was 5 of 154, or 3.2%. Among women who experienced delayed diagnosis, only 19 of 154 experienced signs or symptoms diagnostic for an underlying bowel injury, particularly when the small bowel was injured.
Can mechanical bowel prep positively affect outcomes in gynecologic laparoscopy, or should it be discarded?
Arnold A, Aitchison LP, Abbott J. Preoperative mechanical bowel preparation for abdominal, laparoscopic, and vaginal surgery: a systematic review. J Minim Invasive Gynecol. 2015;22(5):737−752.
Popularized for more than 4 decades, the practice of presurgical bowel preparation is predicated on the notion that the presence of less, versus more, feces can minimize bacterial count and thereby reduce peritoneal contamination. Logically then, surgical site infections (SSIs) should be reduced with bowel preparation. Moreover, the surgical view and bowel handling during laparoscopic surgery should be improved, with surgical times consequently reduced.
Surgeons must weigh the putative benefits of mechanical bowel preparation against the unpleasant experience it causes for patients, as well as the risks of dehydration or electrolyte disturbance it may cause. To this day, a considerable percentage of gynecologists and colorectal surgeons routinely prep the bowel after weighing all of these factors, despite the paucity of evidence for the practice's efficacy to reduce SSI and improve surgical outcomes.7
The results of this recent systematic review critically question the usefulness of preoperative bowel preparation for abdominal, laparoscopic, and vaginal surgery.
Details of the analysis
The authors evaluated high-quality studies on mechanical bowel preparation to assess evidence for:
- surgeon outcomes, including the surgical field and bowel handling
- operative outcomes, including intraoperative complications and operative times
- patient outcomes, including postoperative complications, overall morbidity, and length of stay.
The authors identified RCTs and prospective or retrospective cohort studies in various surgical specialties comparing preoperative bowel preparation to no such prep. Forty-three studies met inclusion criteria: 38 compared prep to no prep, and 5 compared prep to a single rectal enema. Five high-grade studies in gynecology were included (n = 795), with 4 of them RCTs of gynecologic laparoscopy (n = 645).
Operative field and duration
Of the studies comparing bowel prep with no prep, only the 5 gynecologic ones assessed operative field. Surgical view was perceived as improved in only 1 study. In another, surgeons only could guess allocation half the time.
Sixteen studies evaluated impact of mechanical bowel preparation on duration of surgery: 1 high-quality study found a significant reduction in OR time with bowel prep, and 1 moderate-quality study found longer operative time with bowel prep.
Patient outcomes
Of all studies assessing patient outcomes, 3 high-quality studies of colorectal patients (n = 490) found increased complications from prep versus no prep, including anastomotic dehiscence (P = .05), abdominal complications (P = .028), and infectious complications (P = .05).
Length of stay was assessed in 26 studies, with 4 reporting longer hospital stay with bowel prep and the remaining finding no difference between prep and no prep.
Across all specialties, only 2 studies reported improved outcomes with mechanical bowel preparation. One was a high-quality study reporting reduced 30-day morbidity (P = .018) and infectious complication rates (P = .018), and the other was a moderate-quality study that found reduced SSI (P = .0001) and organ space infection (P = .024) in patients undergoing bowel prep.
Mechanical bowel preparation vs enema
Bowel prep was compared with a single rectal enema in 5 studies. In 2 of these, patient outcomes were worse with enema. One high-quality study of 294 patients reported increased intra-abdominal fecal soiling (P = .008) in the enema group. (The surgeons believed that bowel preparation was more likely to be inadequate in this group, 25% compared with 6%, P<.05.) Whereas there was no statistical difference in the incidence of anastomotic leak between these groups, there was higher reoperation rate in the enema-only group where leakage was diagnosed (6 [4.1%] vs 0, respectively; P = .013).
Bowel prep and preoperative and postoperative symptoms
Six high-quality studies reported on the impact of mechanical bowel preparation on patient symptoms, such as nausea, weakness, abdominal distention, and satisfaction before and after surgery. In all but 1 study patients had significantly greater discomfort with bowel preparation. In 2 of the 6 studies, patients had more diarrhea (P = .0003), a delay in the first bowel movement (P = .001), and a slower return to normal diet (P = .004).
What this EVIDENCE means for practice
The theory behind mechanical bowel preparation is not supported by the evidence. Despite the fact that the bowel is not customarily entered, up to 50% of gynecologic surgeons employ bowel preparation, with the hope of improving visualization and decreasing risk of an anastomotic leak. The colorectal studies in this review demonstrate no evidence for decreased anastomotic leak or infectious complications. By extrapolation, there is no evidence that using preoperative bowel prep bestows any benefit if bowel injury occurs inadvertently and if resection or reanastomosis is then required.
Among the 7 studies examining bowel prep in laparoscopy (4 gynecology, 3 urology, and 1 colorectal), only data from 1 demonstrated an improved surgical field (and in this case only by 1 out of 10 on a Likert scale). The impact of mechanical bowel preparation on the visual field is the same for diagnostic or complex laparoscopic surgeries. One high-quality study with deep endometriosis resection demonstrated no change in the operative field as reflected by no practical differences in OR time or complications.
Preparing the bowel for surgery is an intrusive process that reduces patient satisfaction by inducing weakness, abdominal distention, nausea, vomiting, hunger, and thirst. Whereas this systematic analysis failed to confirm any benefit of the process, it provides evidence for the potential for harm. Mechanical bowel preparation should be discarded as a routine preoperative treatment for patients undergoing minimally invasive gynecologic surgery.
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.
Rightly so, the topics of mechanical tissue extraction and hysterectomy approach have dominated the field of obstetrics and gynecology over the past 12 months and more. A profusion of literature has been published on these subjects. However, there are 2 important topics within the field of minimally invasive gynecologic surgery that deserve our attention as well, and I have chosen to focus on these for this Update.
First, laparoscopic treatment of ovarian endometriomas is one of the most commonly performed gynecologic procedures worldwide. Many women undergoing such surgery are of childbearing age and have the desire for future pregnancy. What are best practices for preserving ovarian function in these women? Two studies recently published in the Journal of Minimally Invasive Gynecology addressed this question.
Second, until recently, the rate of bowel injury at laparoscopic gynecologic surgery has not been well established.1 Moreover, mechanical bowel preparation is commonly employed in case intestinal injury does occur, despite the lack of evidence that outcomes of these possible injuries can be improved.2 Understanding the rate of bowel injury can shed light on the overall value of the perceived benefits of bowel preparation. Therefore, I examine 2 recent systematic reviews that analyze the incidence of bowel injury and the value of bowel prep in gynecologic laparoscopic surgery.
bipolar coagulation inferior to suturing or hemostatic sealant for preserving ovarian function
Song T, Kim WY, Lee KW, Kim KH. Effect on ovarian reserve of hemostasis by bipolar coagulation versus suture during laparoendoscopic single-site cystectomy for ovarian endometriomas. J Minim Invasive Gynecol. 2015;22(3):415−420.
Ata B, Turkgeldi E, Seyhan A, Urman B. Effect of hemostatic method on ovarian reserve following laparoscopic endometrioma excision; comparison of suture, hemostatic sealant, and bipolar dessication. A systematic review and meta-analysis. J Minim Invasive Gynecol. 2015;22(3):363−372.
The customary surgical approach for laparoscopic cystectomy is by mechanical stripping of the cyst wall (FIGURE) and the use of bipolar desiccation for hemostasis. Stripping inevitably leads to removal of healthy ovarian cortex,3 especially in inexperienced hands,4 and ovarian follicles inevitably are destroyed during electrosurgical desiccation. When compared with the use of suturing or a hemostatic agent to control bleeding in the ovarian defect, the use of bipolar electrosurgery may harm more of the ovarian cortex, resulting in a comparatively diminished follicular cohort.
Possible deleterious effects on the ovarian reserve can be determined with a blood test to measure anti-Müllerian hormone (AMH) levels postoperatively. Produced by the granulosa cells of the ovary, this hormone directly reflects the remaining ovarian egg supply. Lower levels of AMH have been shown to significantly decrease the success rate of in vitro fertilization (IVF), especially in women older than age 35.5 Moreover, AMH levels in the late reproductive years can be used as a predictive marker of menopause, with lower levels predicting significantly earlier onset.6
Data from 2 recent studies, a quasi-randomized trial by Song and colleagues and a systematic review and meta-analysis by Ata and colleagues emphasize that bipolar desiccation for hemostasis may not be best practice for protecting ovarian reserve during laparoscopic ovarian cystectomy for an endometrioma.
AMH levels decline more significantly for women undergoing bipolar desiccation
Song and colleagues conducted a prospective quasi-randomized study of 125 women whose endometriomas were laparoscopically removed via a single-site approach and managed for hemostasis with either bipolar desiccation or suturing of the ovarian defect with a 2-0 barbed suture. All surgeries were conducted by a single surgeon.
At 3 months postsurgery, mean AMH levels had declined from baseline by 42.2% (interquartile range [IR], 16.5−53.0 ng/mL) in the desiccation group and by 24.6% (IR, 11.6−37.0 ng/mL) in the suture group (P = .001). Multivariate analysis showed that the method used for hemostasis was the only determinant for reduced ovarian reserve.
In their systematic review and meta-analysis, Ata and colleagues included 10 studies--6 qualitative and 4 quantitative. All studies examined the rate of change of serum AMH levels 3 months after laparoscopic removal of an endometrioma.
In their qualitative analysis, 5 of the 6 studies reported a significantly greater decrease in ovarian reserve after bipolar desiccation (varying from 13% to 44%) or a strong trend in the same direction. In the sixth study, the desiccation group had a lower decline in absolute AMH level than in the other 5 studies. The authors note that this 2.7% decline was much lower than the values reported for the bipolar desiccation group of any other study. (Those declines ranged between 19% and 58%.)
Although not significant, in all 3 of the included randomized controlled trials (RCTs), the desiccation groups had a greater loss in AMH level than the hemostatic sealant groups, and in 2 of these RCTs, bipolar desiccation groups had a greater loss than the suturing groups.
Among the 213 study participants in the 3 RCTs and the prospective cohort study included in the quantitative meta-analysis, alternative methods to bipolar desiccation were associated with a 6.95% lower decrease in AMH-level decline (95% confidence interval [CI], −13.0% to −0.9%; P = .02).
What this EVIDENCE means for practice
Compared with the use of bipolar electrosurgery to attain hemostasis, the use of a topical biosurgical agent or suturing could be significantly better for protection of the ovarian follicles during laparoscopic ovarian cystectomy for endometrioma. These alternative methods especially could benefit those women desiring future pregnancy who are demonstrated preoperatively to have a low ovarian reserve. As needed, electrosurgery should be sparingly employed for ovarian hemostasis.
Large Study identifies incidence of bowel injury during gynecologic laproscopy
Llarena NC, Shah AB, Milad MP. Bowel injury in gynecologic laparoscopy: a systematic review. Am J Obstet Gynecol. 2015;125(6):1407−1417.
In no aspect of laparoscopic surgery are preventive strategies more cautiously employed than during peritoneal access. Regardless of the applied technique, there is an irreducible risk of injury to the underlying viscera by either adhesions between the underlying bowel and abdominal wall or during the course of pilot error. Moreover, in the best of hands, bowel injury can occur whenever normal anatomic relationships need to be restored using intra-abdominal adhesiolysis. Given the ubiquity, these risks are never out of the surgeon's mind. Gynecologists are obliged to discuss these risks during the informed consent process.
Until recently, the rate of bowel injury has not been well established. Llarena and colleagues recently have conducted the largest systematic review of the medical literature to date for incidence, presentation, mortality, cause, and location of bowel injury associated with laparoscopic surgery while not necessarily distinguishing for the type of bowel injury. Sixty retrospective and 27 prospective studies met inclusion criteria.
The risk of bowel injury overall and defined
Among 474,063 laparoscopic surgeries conducted between 1972 and 2014, 604 bowel injuries were found, for an incidence of 1 in 769, or 0.13% (95% CI, 0.12−0.14%).
The rate of bowel injury varied by procedure, year, study type, and definition of bowel injury. The incidence of injury according to:
- definition, was 1 in 416 (0.24%) for studies that clearly included serosal injuries and enterotomies versus 1 in 833 (0.12%) for studies not clearly defining the type of bowel injury (relative risk [RR], 0.47; 95% CI, 0.38−0.59; P<.001)
- study type, was 1 in 666 (0.15%) for prospective studies versus 1 in 909 (0.11%) for retrospective studies (RR, 0.78; 95% CI, 0.63−0.96; P = .02)
- procedure, was 1 in 3,333 (0.03%; 95% CI, 0.01−0.03%) for sterilization and 1 in 256 (0.39%; 95% CI, 0.35−0.45%) for hysterectomy
- year, for laparoscopic hysterectomy only, was 1 in 222 (0.45%) before the year 2000 and 1 in 294 (0.34%) after 2000 (RR, 0.75; 95% CI, 0.57−0.98; P = .03).
How were injuries caused, found, and managed?
Thirty studies described the laparoscopic instrument used during 366 reported bowel injuries. The majority of injuries (55%) occurred during initial peritoneal access, with the Veress needle or trocar causing the damage. This was followed by electrosurgery (29%), dissection (11%), and forceps or scissors (4.1%).
According to 40 studies describing 307 injuries, bowel injuries most often were managed by converting to laparotomy (80%); only 8% of injuries were managed with laparoscopy and 2% expectantly.
Surgery to repair the bowel injury was delayed in 154 (41%) of 375 cases. The median time to injury discovery was 3 days (range, 1−13 days).
In only 19 cases were the presenting signs and symptoms of bowel injury recorded. Those reported from most to least often were: peritonitis, abdominal pain, fever, abdominal distention, leukocytosis, leukopenia, and septic shock.
Mortality
Mortality as an outcome was only reported in 29 of the total 90 studies; therefore, mortality may be underreported. Overall, however, death occurred in 1 (0.8%) of 125 bowel injuries.
The overall mortality rate from bowel injury--calculated from the only 42 studies that explicitly mentioned mortality as an outcome--was 1 in 125, or 0.8% (95% CI, 0.36%-1.9%). All 5 reported deaths occurred as a result of delayed recognition of bowel injury, which made the mortality rate for unrecognized bowel injury 1 in 31, or 3.2% (95% CI, 1%-7%). No deaths occurred when the bowel injury was noted intraoperatively.
What this EVIDENCE means for practice
In this review of 474,063 laparoscopic procedures, bowel injury occurred in 1 in 769, or 0.13% of procedures. Bowel injury is more apt to occur during more complicated laparoscopic procedures (compared with laparoscopic sterilization procedures, the risk during hysterectomy was greater than 10-fold).
Most of the injuries were managed by laparotomic surgery despite the potential to repair bowel injury by laparoscopy. Validating that peritoneal access is a high risk part of laparoscopic surgery, the majority of the injuries occurred during insufflation with a Veress needle or during abdominal access by trocar insertion. Nearly one-third of the injuries were from the use of electrosurgery, which are typically associated with a delay in presentation.
In this study, 41% of the injuries were unrecognized at the time of surgery. All 5 of the reported deaths were associated with a delay in diagnosis, with an overall mortality rate of 1 of 125, or 0.8%. Since all of these deaths were associated with a delay in diagnosis, the rate of mortality in unrecognized bowel injury was 5 of 154, or 3.2%. Among women who experienced delayed diagnosis, only 19 of 154 experienced signs or symptoms diagnostic for an underlying bowel injury, particularly when the small bowel was injured.
Can mechanical bowel prep positively affect outcomes in gynecologic laparoscopy, or should it be discarded?
Arnold A, Aitchison LP, Abbott J. Preoperative mechanical bowel preparation for abdominal, laparoscopic, and vaginal surgery: a systematic review. J Minim Invasive Gynecol. 2015;22(5):737−752.
Popularized for more than 4 decades, the practice of presurgical bowel preparation is predicated on the notion that the presence of less, versus more, feces can minimize bacterial count and thereby reduce peritoneal contamination. Logically then, surgical site infections (SSIs) should be reduced with bowel preparation. Moreover, the surgical view and bowel handling during laparoscopic surgery should be improved, with surgical times consequently reduced.
Surgeons must weigh the putative benefits of mechanical bowel preparation against the unpleasant experience it causes for patients, as well as the risks of dehydration or electrolyte disturbance it may cause. To this day, a considerable percentage of gynecologists and colorectal surgeons routinely prep the bowel after weighing all of these factors, despite the paucity of evidence for the practice's efficacy to reduce SSI and improve surgical outcomes.7
The results of this recent systematic review critically question the usefulness of preoperative bowel preparation for abdominal, laparoscopic, and vaginal surgery.
Details of the analysis
The authors evaluated high-quality studies on mechanical bowel preparation to assess evidence for:
- surgeon outcomes, including the surgical field and bowel handling
- operative outcomes, including intraoperative complications and operative times
- patient outcomes, including postoperative complications, overall morbidity, and length of stay.
The authors identified RCTs and prospective or retrospective cohort studies in various surgical specialties comparing preoperative bowel preparation to no such prep. Forty-three studies met inclusion criteria: 38 compared prep to no prep, and 5 compared prep to a single rectal enema. Five high-grade studies in gynecology were included (n = 795), with 4 of them RCTs of gynecologic laparoscopy (n = 645).
Operative field and duration
Of the studies comparing bowel prep with no prep, only the 5 gynecologic ones assessed operative field. Surgical view was perceived as improved in only 1 study. In another, surgeons only could guess allocation half the time.
Sixteen studies evaluated impact of mechanical bowel preparation on duration of surgery: 1 high-quality study found a significant reduction in OR time with bowel prep, and 1 moderate-quality study found longer operative time with bowel prep.
Patient outcomes
Of all studies assessing patient outcomes, 3 high-quality studies of colorectal patients (n = 490) found increased complications from prep versus no prep, including anastomotic dehiscence (P = .05), abdominal complications (P = .028), and infectious complications (P = .05).
Length of stay was assessed in 26 studies, with 4 reporting longer hospital stay with bowel prep and the remaining finding no difference between prep and no prep.
Across all specialties, only 2 studies reported improved outcomes with mechanical bowel preparation. One was a high-quality study reporting reduced 30-day morbidity (P = .018) and infectious complication rates (P = .018), and the other was a moderate-quality study that found reduced SSI (P = .0001) and organ space infection (P = .024) in patients undergoing bowel prep.
Mechanical bowel preparation vs enema
Bowel prep was compared with a single rectal enema in 5 studies. In 2 of these, patient outcomes were worse with enema. One high-quality study of 294 patients reported increased intra-abdominal fecal soiling (P = .008) in the enema group. (The surgeons believed that bowel preparation was more likely to be inadequate in this group, 25% compared with 6%, P<.05.) Whereas there was no statistical difference in the incidence of anastomotic leak between these groups, there was higher reoperation rate in the enema-only group where leakage was diagnosed (6 [4.1%] vs 0, respectively; P = .013).
Bowel prep and preoperative and postoperative symptoms
Six high-quality studies reported on the impact of mechanical bowel preparation on patient symptoms, such as nausea, weakness, abdominal distention, and satisfaction before and after surgery. In all but 1 study patients had significantly greater discomfort with bowel preparation. In 2 of the 6 studies, patients had more diarrhea (P = .0003), a delay in the first bowel movement (P = .001), and a slower return to normal diet (P = .004).
What this EVIDENCE means for practice
The theory behind mechanical bowel preparation is not supported by the evidence. Despite the fact that the bowel is not customarily entered, up to 50% of gynecologic surgeons employ bowel preparation, with the hope of improving visualization and decreasing risk of an anastomotic leak. The colorectal studies in this review demonstrate no evidence for decreased anastomotic leak or infectious complications. By extrapolation, there is no evidence that using preoperative bowel prep bestows any benefit if bowel injury occurs inadvertently and if resection or reanastomosis is then required.
Among the 7 studies examining bowel prep in laparoscopy (4 gynecology, 3 urology, and 1 colorectal), only data from 1 demonstrated an improved surgical field (and in this case only by 1 out of 10 on a Likert scale). The impact of mechanical bowel preparation on the visual field is the same for diagnostic or complex laparoscopic surgeries. One high-quality study with deep endometriosis resection demonstrated no change in the operative field as reflected by no practical differences in OR time or complications.
Preparing the bowel for surgery is an intrusive process that reduces patient satisfaction by inducing weakness, abdominal distention, nausea, vomiting, hunger, and thirst. Whereas this systematic analysis failed to confirm any benefit of the process, it provides evidence for the potential for harm. Mechanical bowel preparation should be discarded as a routine preoperative treatment for patients undergoing minimally invasive gynecologic surgery.
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.
In this article
- Preserving ovarian function at laparoscopic cystectomy
- Incidence of bowel injury during gyn surgery
- Usefulness and safety of mechanical bowel preparation
Cesarean scar defect: What is it and how should it be treated?
Cesarean delivery is one of the most common surgical procedures in women, with rates of 30% or more in the United States.1 As a result, the rate is rising for cesarean scar defect—the presence of a “niche” at the site of cesarean delivery scar—with the reported prevalence between 24% and 70% in a random population of women with at least one cesarean delivery.2 Other terms for cesarean scar defect include a niche, isthmocele, uteroperitoneal fistula, and diverticulum.1–9
Formation of cesarean scar defect
Cesarean scar defect forms after cesarean delivery, at the site of hysterotomy, on the anterior wall of the uterine isthmus (FIGURE 1). While this is the typical location, the defect has also been found at the endocervical canal and mid-uterine body. Improper healing of the cesarean incision leads to thinning of the anterior uterine wall, which creates an indentation and fluid-filled pouch at the cesarean scar site. The exact reason why a niche develops has not yet been determined; however, there are several hypotheses, broken down by pregnancy-related and patient-related factors. Surgical techniques that may increase the chance of niche development include low (cervical) hysterotomy, single-layer uterine wall closure, use of locking sutures, closure of hysterotomy with endometrial-sparing technique, and multiple cesarean deliveries.3,4 Patients with medical conditions that may impact wound healing (such as diabetes and smoking) may be at increased risk for niche formation.
Viewed hysteroscopically, the defect appears as a concave shape in the anterior uterine wall; to the inexperienced eye, it may resemble a second cavity (FIGURE 2).
Pelvic pain and other serious consequences
The presence of fibrotic tissue in the niche acts like a valve, leading to the accumulation of blood in this reservoir-like area. A niche thus can cause delayed menstruation through the cervix, resulting in abnormal bleeding, pelvic pain, vaginal discharge, dysmenorrhea, dyspareunia, and infertility. Accumulated blood in this area can ultimately degrade cervical mucus and sperm quality, as well as inhibit sperm transport, a proposed mechanism of infertility.5,6 Women with a niche who conceive are at potential risk for cesarean scar ectopic pregnancy, with the embryo implanting in the pouch and subsequently growing and developing improperly.
Read about evaluation and treatment.
Evaluation and treatment
Patients presenting with the symptoms de-scribed above who have had a prior cesarean delivery should be evaluated for a cesarean scar defect.9 The best time to assess for the abnormality is after the patient’s menstrual cycle, when the endometrial lining is at its thinnest and recently menstruated blood has collected in the defect (this can highlight the niche on imaging). Transvaginal ultrasonography (FIGURE 3) or saline-infusion sonohysterogram serve as a first-line test for in-office diagnosis.7 Magnetic resonance imaging (MRI), 3-D ultrasonography, and hysteroscopy are additional useful imaging modalities that can aid in the diagnosis.
Treatments for cesarean scar defect vary dramatically and include hormonal therapy, hysteroscopic resection, vaginal or laparoscopic repair, and hysterectomy. Nonsurgical treatment should be reserved for women who desire a noninvasive approach, as the evidence for symptom resolution is limited.8
To promote fertility and decrease symptoms, the abnormal, fibrotic tissue must be removed. In our experience, since 2003, we have found that use of a laparoscopic approach is best for women desiring future fertility and that hysteroscopic resection is best for women whose childbearing is completed.9 Our management is dictated by the patient’s fertility plans, since there is concern that cesarean scar defect in a gravid uterus presents a risk for uterine rupture. The laparoscopic approach allows the defect to be repaired and the integrity of the myometrium restored.9
What are the coding options for cesarean scar defect repair?
Melanie Witt, RN, CPC, COBGC, MA
As the accompanying article discusses, the primary treatment for a cesarean scar defect depends on whether the patient wishes to preserve fertility, but assigning a procedure code for either surgical option will entail reporting an unlisted procedure code.
Under Current Procedural Terminology (CPT) guidelines (which are developed and copyrighted by the American Medical Association), procedure code selected must accurately describe the service/procedure performed rather than just approximate the service. This means that when a procedure-specific code does not exist, an unlisted procedure code that represents the type of surgery, the approach, and the anatomic site needs to be selected.
When an unlisted CPT code is reported, payment is based on the complexity of the surgery, and one way to communicate this to a payer is to provide additional documentation that not only includes the operative report but also suggests one or more existing CPT codes that have a published relative value unit (RVU) that approximates the work involved for the unlisted procedure.
The coding options for hysteroscopic and laparoscopic treatment options are listed below. The comparison codes offered will give the surgeon a range to look at, but the ultimate decision to use one of those suggested, or to choose an entirely different comparison code, is entirely within the control of the physician.
ICD-10-CM diagnostic coding
While the cesarean scar defect is a sequela of cesarean delivery, which is always reported as a secondary code, the choice of a primary diagnosis code can be either a gynecologic and/or an obstetric complication code. The choice may be determined by payer policy, as the use of an obstetric complication may not be accepted with a gynecologic procedure code. From a coding perspective, however, use of all 3 of these codes from the International Classification of Diseases, 10th Revision, Clinical Modification (ICD-10-CM) paints the most accurate description of the defect and its cause:
- N85.8 Other specified noninflammatory disorders of uterus versus
- O34.21 Maternal care for scar from previous cesarean delivery plus
- O94 Sequelae of complication of pregnancy, childbirth, and the puerperium.
Hysteroscopic resection codes:
- 58579 Unlisted hysteroscopy procedure, uterus
- The codes that may most closely approximate the physician work include 58561 (Hysteroscopy, surgical; with removal of leiomyomata) with 15.48 RVUs or 58560 (Hysteroscopy, surgical; with division or resection of intrauterine septum [any method]) with 10.92 RVUs.
Laparoscopic repair codes:
- 58578 Unlisted laparoscopy procedure, uterus
- The codes that may most closely approximate the physician work include 58520 (Hysterorrhaphy, repair of ruptured uterus [nonobstetrical] 24.25 RVUs or 58662 (Laparoscopy, surgical; with fulguration or excision of lesions of the ovary, pelvic viscera, or peritoneal surface by any method) with 20.14 RVUs.
You may also want to report a diagnostic hysteroscopy (code 58555), but keep in mind that payment will depend on documentation that clearly indicates that the use of the hysteroscope was for diagnostic purposes. Use of the hysteroscope to simply identify the surgical site to be repaired via the laparoscope will usually not be reimbursed separately.
Ms. Witt is an independent coding and documentation consultant and former program manager, department of coding and nomenclature, American Congress of Obstetricians and Gynecologists.
The author reports no financial relationships relevant to this article.
Read about techniques for repair.
Techniques for repairing cesarean scar defect
For hysteroscopic resection of a niche, the uterus is distended and the intrauterine defect is visualized hysteroscopically, as seen in FIGURE 2. Using a bipolar or unipolar resectoscope, resect the fibrotic tissue of the defect and endometrial-like glands present within the niche. The goal of this relatively quick procedure is to open up the reservoir and facilitate the complete drainage of menstrual blood, thus alleviating the patient’s symptoms.Postoperatively, follow the patient for symptom resolution, and evaluate for defect resolution with transvaginal ultrasonography.
For a laparoscopic repair, first identify the niche hysteroscopically. At the same time as hysteroscopic examination of the cavity, the defect can be evaluated laparoscopically (FIGURE 4). The light from the hysteroscope can be visualized easily laparoscopically because of the thinned myometrium in the area of the defect. Map out the niche by transvaginally passing a cervical dilator into the defect in the uterine cavity (FIGURE 5). Again, given the thinning of this segment of the uterus, the dilator can be easily visualized laparoscopically. Be cautious when placing this dilator, as there is often overlying bladder. Prevent incidental cystotomy by gently advancing the dilator into the defect only until the niche can be adequately detected.9At this point, develop a bladder flap by opening the vesicovaginal and vesicocervical space, mobilizing the bladder inferiorly (FIGURE 6). With the guide of the dilator mapping out the defect (FIGURE 7), excise the fibrotic edges of the niche with thermal energy (monopolar cautery or CO2 laser) or sharp dissection (FIGURE 8). This leaves healthy myometrial tissue margins. Reapproximate these margins with absorbable suture (2-0 polyglactin 910 [Vicryl]) in an interrupted or running fashion, in 2 layers9 (FIGURE 9). Following the laparoscopic repair, perform hysteroscopic evaluation of the uterine cavity to assure complete resolution of the defect (FIGURE 10). With the hysteroscope in place, perform concurrent laparoscopic assessment of the repair. Check for impermeability by assuring no hysteroscopic fluid escapes at the site of repaired hysterotomy.9
Postoperative care requires following the patient for symptom resolution and counseling regarding future fertility plans. We recommend that patients wait 6 months following the procedure before attempting conception.
When it comes to recommendations regarding preventing cesarean scar defects, additional randomized controlled trials need to be performed to evaluate various surgical techniques. At this time, there is no conclusive evidence that one method of hysterotomy closure is superior to another in preventing cesarean scar defect.
Symptoms often resolve with repair
When a patient with a prior cesarean delivery presents with symptoms of abnormal uterine bleeding, vaginal discharge, dysmenorrhea, dyspareunia, pelvic pain, or infertility that remain unexplained, consider cesarean scar defect as the culprit. Once a diagnosis of niche has been confirmed, the treatment approach should be dictated by the patient’s plans for future fertility. Hysteroscopic resection has been reported to have a 92% to 100% success rate for resolving symptoms of pain and bleeding, while 75% of patients undergoing laparoscopic niche repair for infertility achieved pregnancy.10,11 In our practice, a majority of patients experience symptom relief and go on to carry healthy pregnancies.
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.
Cesarean delivery is one of the most common surgical procedures in women, with rates of 30% or more in the United States.1 As a result, the rate is rising for cesarean scar defect—the presence of a “niche” at the site of cesarean delivery scar—with the reported prevalence between 24% and 70% in a random population of women with at least one cesarean delivery.2 Other terms for cesarean scar defect include a niche, isthmocele, uteroperitoneal fistula, and diverticulum.1–9
Formation of cesarean scar defect
Cesarean scar defect forms after cesarean delivery, at the site of hysterotomy, on the anterior wall of the uterine isthmus (FIGURE 1). While this is the typical location, the defect has also been found at the endocervical canal and mid-uterine body. Improper healing of the cesarean incision leads to thinning of the anterior uterine wall, which creates an indentation and fluid-filled pouch at the cesarean scar site. The exact reason why a niche develops has not yet been determined; however, there are several hypotheses, broken down by pregnancy-related and patient-related factors. Surgical techniques that may increase the chance of niche development include low (cervical) hysterotomy, single-layer uterine wall closure, use of locking sutures, closure of hysterotomy with endometrial-sparing technique, and multiple cesarean deliveries.3,4 Patients with medical conditions that may impact wound healing (such as diabetes and smoking) may be at increased risk for niche formation.
Viewed hysteroscopically, the defect appears as a concave shape in the anterior uterine wall; to the inexperienced eye, it may resemble a second cavity (FIGURE 2).
Pelvic pain and other serious consequences
The presence of fibrotic tissue in the niche acts like a valve, leading to the accumulation of blood in this reservoir-like area. A niche thus can cause delayed menstruation through the cervix, resulting in abnormal bleeding, pelvic pain, vaginal discharge, dysmenorrhea, dyspareunia, and infertility. Accumulated blood in this area can ultimately degrade cervical mucus and sperm quality, as well as inhibit sperm transport, a proposed mechanism of infertility.5,6 Women with a niche who conceive are at potential risk for cesarean scar ectopic pregnancy, with the embryo implanting in the pouch and subsequently growing and developing improperly.
Read about evaluation and treatment.
Evaluation and treatment
Patients presenting with the symptoms de-scribed above who have had a prior cesarean delivery should be evaluated for a cesarean scar defect.9 The best time to assess for the abnormality is after the patient’s menstrual cycle, when the endometrial lining is at its thinnest and recently menstruated blood has collected in the defect (this can highlight the niche on imaging). Transvaginal ultrasonography (FIGURE 3) or saline-infusion sonohysterogram serve as a first-line test for in-office diagnosis.7 Magnetic resonance imaging (MRI), 3-D ultrasonography, and hysteroscopy are additional useful imaging modalities that can aid in the diagnosis.
Treatments for cesarean scar defect vary dramatically and include hormonal therapy, hysteroscopic resection, vaginal or laparoscopic repair, and hysterectomy. Nonsurgical treatment should be reserved for women who desire a noninvasive approach, as the evidence for symptom resolution is limited.8
To promote fertility and decrease symptoms, the abnormal, fibrotic tissue must be removed. In our experience, since 2003, we have found that use of a laparoscopic approach is best for women desiring future fertility and that hysteroscopic resection is best for women whose childbearing is completed.9 Our management is dictated by the patient’s fertility plans, since there is concern that cesarean scar defect in a gravid uterus presents a risk for uterine rupture. The laparoscopic approach allows the defect to be repaired and the integrity of the myometrium restored.9
What are the coding options for cesarean scar defect repair?
Melanie Witt, RN, CPC, COBGC, MA
As the accompanying article discusses, the primary treatment for a cesarean scar defect depends on whether the patient wishes to preserve fertility, but assigning a procedure code for either surgical option will entail reporting an unlisted procedure code.
Under Current Procedural Terminology (CPT) guidelines (which are developed and copyrighted by the American Medical Association), procedure code selected must accurately describe the service/procedure performed rather than just approximate the service. This means that when a procedure-specific code does not exist, an unlisted procedure code that represents the type of surgery, the approach, and the anatomic site needs to be selected.
When an unlisted CPT code is reported, payment is based on the complexity of the surgery, and one way to communicate this to a payer is to provide additional documentation that not only includes the operative report but also suggests one or more existing CPT codes that have a published relative value unit (RVU) that approximates the work involved for the unlisted procedure.
The coding options for hysteroscopic and laparoscopic treatment options are listed below. The comparison codes offered will give the surgeon a range to look at, but the ultimate decision to use one of those suggested, or to choose an entirely different comparison code, is entirely within the control of the physician.
ICD-10-CM diagnostic coding
While the cesarean scar defect is a sequela of cesarean delivery, which is always reported as a secondary code, the choice of a primary diagnosis code can be either a gynecologic and/or an obstetric complication code. The choice may be determined by payer policy, as the use of an obstetric complication may not be accepted with a gynecologic procedure code. From a coding perspective, however, use of all 3 of these codes from the International Classification of Diseases, 10th Revision, Clinical Modification (ICD-10-CM) paints the most accurate description of the defect and its cause:
- N85.8 Other specified noninflammatory disorders of uterus versus
- O34.21 Maternal care for scar from previous cesarean delivery plus
- O94 Sequelae of complication of pregnancy, childbirth, and the puerperium.
Hysteroscopic resection codes:
- 58579 Unlisted hysteroscopy procedure, uterus
- The codes that may most closely approximate the physician work include 58561 (Hysteroscopy, surgical; with removal of leiomyomata) with 15.48 RVUs or 58560 (Hysteroscopy, surgical; with division or resection of intrauterine septum [any method]) with 10.92 RVUs.
Laparoscopic repair codes:
- 58578 Unlisted laparoscopy procedure, uterus
- The codes that may most closely approximate the physician work include 58520 (Hysterorrhaphy, repair of ruptured uterus [nonobstetrical] 24.25 RVUs or 58662 (Laparoscopy, surgical; with fulguration or excision of lesions of the ovary, pelvic viscera, or peritoneal surface by any method) with 20.14 RVUs.
You may also want to report a diagnostic hysteroscopy (code 58555), but keep in mind that payment will depend on documentation that clearly indicates that the use of the hysteroscope was for diagnostic purposes. Use of the hysteroscope to simply identify the surgical site to be repaired via the laparoscope will usually not be reimbursed separately.
Ms. Witt is an independent coding and documentation consultant and former program manager, department of coding and nomenclature, American Congress of Obstetricians and Gynecologists.
The author reports no financial relationships relevant to this article.
Read about techniques for repair.
Techniques for repairing cesarean scar defect
For hysteroscopic resection of a niche, the uterus is distended and the intrauterine defect is visualized hysteroscopically, as seen in FIGURE 2. Using a bipolar or unipolar resectoscope, resect the fibrotic tissue of the defect and endometrial-like glands present within the niche. The goal of this relatively quick procedure is to open up the reservoir and facilitate the complete drainage of menstrual blood, thus alleviating the patient’s symptoms.Postoperatively, follow the patient for symptom resolution, and evaluate for defect resolution with transvaginal ultrasonography.
For a laparoscopic repair, first identify the niche hysteroscopically. At the same time as hysteroscopic examination of the cavity, the defect can be evaluated laparoscopically (FIGURE 4). The light from the hysteroscope can be visualized easily laparoscopically because of the thinned myometrium in the area of the defect. Map out the niche by transvaginally passing a cervical dilator into the defect in the uterine cavity (FIGURE 5). Again, given the thinning of this segment of the uterus, the dilator can be easily visualized laparoscopically. Be cautious when placing this dilator, as there is often overlying bladder. Prevent incidental cystotomy by gently advancing the dilator into the defect only until the niche can be adequately detected.9At this point, develop a bladder flap by opening the vesicovaginal and vesicocervical space, mobilizing the bladder inferiorly (FIGURE 6). With the guide of the dilator mapping out the defect (FIGURE 7), excise the fibrotic edges of the niche with thermal energy (monopolar cautery or CO2 laser) or sharp dissection (FIGURE 8). This leaves healthy myometrial tissue margins. Reapproximate these margins with absorbable suture (2-0 polyglactin 910 [Vicryl]) in an interrupted or running fashion, in 2 layers9 (FIGURE 9). Following the laparoscopic repair, perform hysteroscopic evaluation of the uterine cavity to assure complete resolution of the defect (FIGURE 10). With the hysteroscope in place, perform concurrent laparoscopic assessment of the repair. Check for impermeability by assuring no hysteroscopic fluid escapes at the site of repaired hysterotomy.9
Postoperative care requires following the patient for symptom resolution and counseling regarding future fertility plans. We recommend that patients wait 6 months following the procedure before attempting conception.
When it comes to recommendations regarding preventing cesarean scar defects, additional randomized controlled trials need to be performed to evaluate various surgical techniques. At this time, there is no conclusive evidence that one method of hysterotomy closure is superior to another in preventing cesarean scar defect.
Symptoms often resolve with repair
When a patient with a prior cesarean delivery presents with symptoms of abnormal uterine bleeding, vaginal discharge, dysmenorrhea, dyspareunia, pelvic pain, or infertility that remain unexplained, consider cesarean scar defect as the culprit. Once a diagnosis of niche has been confirmed, the treatment approach should be dictated by the patient’s plans for future fertility. Hysteroscopic resection has been reported to have a 92% to 100% success rate for resolving symptoms of pain and bleeding, while 75% of patients undergoing laparoscopic niche repair for infertility achieved pregnancy.10,11 In our practice, a majority of patients experience symptom relief and go on to carry healthy pregnancies.
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.
Cesarean delivery is one of the most common surgical procedures in women, with rates of 30% or more in the United States.1 As a result, the rate is rising for cesarean scar defect—the presence of a “niche” at the site of cesarean delivery scar—with the reported prevalence between 24% and 70% in a random population of women with at least one cesarean delivery.2 Other terms for cesarean scar defect include a niche, isthmocele, uteroperitoneal fistula, and diverticulum.1–9
Formation of cesarean scar defect
Cesarean scar defect forms after cesarean delivery, at the site of hysterotomy, on the anterior wall of the uterine isthmus (FIGURE 1). While this is the typical location, the defect has also been found at the endocervical canal and mid-uterine body. Improper healing of the cesarean incision leads to thinning of the anterior uterine wall, which creates an indentation and fluid-filled pouch at the cesarean scar site. The exact reason why a niche develops has not yet been determined; however, there are several hypotheses, broken down by pregnancy-related and patient-related factors. Surgical techniques that may increase the chance of niche development include low (cervical) hysterotomy, single-layer uterine wall closure, use of locking sutures, closure of hysterotomy with endometrial-sparing technique, and multiple cesarean deliveries.3,4 Patients with medical conditions that may impact wound healing (such as diabetes and smoking) may be at increased risk for niche formation.
Viewed hysteroscopically, the defect appears as a concave shape in the anterior uterine wall; to the inexperienced eye, it may resemble a second cavity (FIGURE 2).
Pelvic pain and other serious consequences
The presence of fibrotic tissue in the niche acts like a valve, leading to the accumulation of blood in this reservoir-like area. A niche thus can cause delayed menstruation through the cervix, resulting in abnormal bleeding, pelvic pain, vaginal discharge, dysmenorrhea, dyspareunia, and infertility. Accumulated blood in this area can ultimately degrade cervical mucus and sperm quality, as well as inhibit sperm transport, a proposed mechanism of infertility.5,6 Women with a niche who conceive are at potential risk for cesarean scar ectopic pregnancy, with the embryo implanting in the pouch and subsequently growing and developing improperly.
Read about evaluation and treatment.
Evaluation and treatment
Patients presenting with the symptoms de-scribed above who have had a prior cesarean delivery should be evaluated for a cesarean scar defect.9 The best time to assess for the abnormality is after the patient’s menstrual cycle, when the endometrial lining is at its thinnest and recently menstruated blood has collected in the defect (this can highlight the niche on imaging). Transvaginal ultrasonography (FIGURE 3) or saline-infusion sonohysterogram serve as a first-line test for in-office diagnosis.7 Magnetic resonance imaging (MRI), 3-D ultrasonography, and hysteroscopy are additional useful imaging modalities that can aid in the diagnosis.
Treatments for cesarean scar defect vary dramatically and include hormonal therapy, hysteroscopic resection, vaginal or laparoscopic repair, and hysterectomy. Nonsurgical treatment should be reserved for women who desire a noninvasive approach, as the evidence for symptom resolution is limited.8
To promote fertility and decrease symptoms, the abnormal, fibrotic tissue must be removed. In our experience, since 2003, we have found that use of a laparoscopic approach is best for women desiring future fertility and that hysteroscopic resection is best for women whose childbearing is completed.9 Our management is dictated by the patient’s fertility plans, since there is concern that cesarean scar defect in a gravid uterus presents a risk for uterine rupture. The laparoscopic approach allows the defect to be repaired and the integrity of the myometrium restored.9
What are the coding options for cesarean scar defect repair?
Melanie Witt, RN, CPC, COBGC, MA
As the accompanying article discusses, the primary treatment for a cesarean scar defect depends on whether the patient wishes to preserve fertility, but assigning a procedure code for either surgical option will entail reporting an unlisted procedure code.
Under Current Procedural Terminology (CPT) guidelines (which are developed and copyrighted by the American Medical Association), procedure code selected must accurately describe the service/procedure performed rather than just approximate the service. This means that when a procedure-specific code does not exist, an unlisted procedure code that represents the type of surgery, the approach, and the anatomic site needs to be selected.
When an unlisted CPT code is reported, payment is based on the complexity of the surgery, and one way to communicate this to a payer is to provide additional documentation that not only includes the operative report but also suggests one or more existing CPT codes that have a published relative value unit (RVU) that approximates the work involved for the unlisted procedure.
The coding options for hysteroscopic and laparoscopic treatment options are listed below. The comparison codes offered will give the surgeon a range to look at, but the ultimate decision to use one of those suggested, or to choose an entirely different comparison code, is entirely within the control of the physician.
ICD-10-CM diagnostic coding
While the cesarean scar defect is a sequela of cesarean delivery, which is always reported as a secondary code, the choice of a primary diagnosis code can be either a gynecologic and/or an obstetric complication code. The choice may be determined by payer policy, as the use of an obstetric complication may not be accepted with a gynecologic procedure code. From a coding perspective, however, use of all 3 of these codes from the International Classification of Diseases, 10th Revision, Clinical Modification (ICD-10-CM) paints the most accurate description of the defect and its cause:
- N85.8 Other specified noninflammatory disorders of uterus versus
- O34.21 Maternal care for scar from previous cesarean delivery plus
- O94 Sequelae of complication of pregnancy, childbirth, and the puerperium.
Hysteroscopic resection codes:
- 58579 Unlisted hysteroscopy procedure, uterus
- The codes that may most closely approximate the physician work include 58561 (Hysteroscopy, surgical; with removal of leiomyomata) with 15.48 RVUs or 58560 (Hysteroscopy, surgical; with division or resection of intrauterine septum [any method]) with 10.92 RVUs.
Laparoscopic repair codes:
- 58578 Unlisted laparoscopy procedure, uterus
- The codes that may most closely approximate the physician work include 58520 (Hysterorrhaphy, repair of ruptured uterus [nonobstetrical] 24.25 RVUs or 58662 (Laparoscopy, surgical; with fulguration or excision of lesions of the ovary, pelvic viscera, or peritoneal surface by any method) with 20.14 RVUs.
You may also want to report a diagnostic hysteroscopy (code 58555), but keep in mind that payment will depend on documentation that clearly indicates that the use of the hysteroscope was for diagnostic purposes. Use of the hysteroscope to simply identify the surgical site to be repaired via the laparoscope will usually not be reimbursed separately.
Ms. Witt is an independent coding and documentation consultant and former program manager, department of coding and nomenclature, American Congress of Obstetricians and Gynecologists.
The author reports no financial relationships relevant to this article.
Read about techniques for repair.
Techniques for repairing cesarean scar defect
For hysteroscopic resection of a niche, the uterus is distended and the intrauterine defect is visualized hysteroscopically, as seen in FIGURE 2. Using a bipolar or unipolar resectoscope, resect the fibrotic tissue of the defect and endometrial-like glands present within the niche. The goal of this relatively quick procedure is to open up the reservoir and facilitate the complete drainage of menstrual blood, thus alleviating the patient’s symptoms.Postoperatively, follow the patient for symptom resolution, and evaluate for defect resolution with transvaginal ultrasonography.
For a laparoscopic repair, first identify the niche hysteroscopically. At the same time as hysteroscopic examination of the cavity, the defect can be evaluated laparoscopically (FIGURE 4). The light from the hysteroscope can be visualized easily laparoscopically because of the thinned myometrium in the area of the defect. Map out the niche by transvaginally passing a cervical dilator into the defect in the uterine cavity (FIGURE 5). Again, given the thinning of this segment of the uterus, the dilator can be easily visualized laparoscopically. Be cautious when placing this dilator, as there is often overlying bladder. Prevent incidental cystotomy by gently advancing the dilator into the defect only until the niche can be adequately detected.9At this point, develop a bladder flap by opening the vesicovaginal and vesicocervical space, mobilizing the bladder inferiorly (FIGURE 6). With the guide of the dilator mapping out the defect (FIGURE 7), excise the fibrotic edges of the niche with thermal energy (monopolar cautery or CO2 laser) or sharp dissection (FIGURE 8). This leaves healthy myometrial tissue margins. Reapproximate these margins with absorbable suture (2-0 polyglactin 910 [Vicryl]) in an interrupted or running fashion, in 2 layers9 (FIGURE 9). Following the laparoscopic repair, perform hysteroscopic evaluation of the uterine cavity to assure complete resolution of the defect (FIGURE 10). With the hysteroscope in place, perform concurrent laparoscopic assessment of the repair. Check for impermeability by assuring no hysteroscopic fluid escapes at the site of repaired hysterotomy.9
Postoperative care requires following the patient for symptom resolution and counseling regarding future fertility plans. We recommend that patients wait 6 months following the procedure before attempting conception.
When it comes to recommendations regarding preventing cesarean scar defects, additional randomized controlled trials need to be performed to evaluate various surgical techniques. At this time, there is no conclusive evidence that one method of hysterotomy closure is superior to another in preventing cesarean scar defect.
Symptoms often resolve with repair
When a patient with a prior cesarean delivery presents with symptoms of abnormal uterine bleeding, vaginal discharge, dysmenorrhea, dyspareunia, pelvic pain, or infertility that remain unexplained, consider cesarean scar defect as the culprit. Once a diagnosis of niche has been confirmed, the treatment approach should be dictated by the patient’s plans for future fertility. Hysteroscopic resection has been reported to have a 92% to 100% success rate for resolving symptoms of pain and bleeding, while 75% of patients undergoing laparoscopic niche repair for infertility achieved pregnancy.10,11 In our practice, a majority of patients experience symptom relief and go on to carry healthy pregnancies.
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.
In this Article
Intractable shoulder dystocia: A posterior axilla maneuver may save the day
Shoulder dystocia is an unpredictable obstetric emergency that challenges all obstetricians and midwives. In response to a shoulder dystocia emergency, most clinicians implement a sequence of well-practiced steps that begin with early recognition of the problem, clear communication of the emergency with delivery room staff, and a call for help to available clinicians. Management steps may include:
- instructing the mother to stop pushing and moving the mother's buttocks to the edge of the bed
- ensuring there is not a tight nuchal cord
- committing to avoiding the use of excessive force on the fetal head and neck
- considering performing an episiotomy
- performing the McRoberts maneuver combined with suprapubic pressure
- using a rotational maneuver, such as the Woods maneuver or the Rubin maneuver
- delivering the posterior arm
- considering the Gaskin all-four maneuver.
When initial management steps are not enoughIf this sequence of steps does not result in successful vaginal delivery, additional options include: clavicle fracture, cephalic replacement followed by cesarean delivery (Zavanelli maneuver), symphysiotomy, or fundal pressure combined with a rotational maneuver. Another simple intervention that is not discussed widely in medical textbooks or taught during training is the posterior axilla maneuver.
Posterior axilla maneuversVarying posterior axilla maneuvers have been described by many expert obstetricians, including Willughby (17th Century),1 Holman (1963),2 Schramm (1983),3 Menticoglou (2006),4 and Hofmeyr and Cluver (2009, 2015).5−7
Willughby maneuverPercival Willughby’s (1596−1685) description of a posterior axilla maneuver was brief1:
After the head is born, if the child through the greatness of the shoulders, should stick at the neck, let the midwife put her fingers under the child's armpit and give it a nudge, thrusting it to the other side with her finger, drawing the child or she may quickly bring forth the shoulders, without offering to put it forth by her hands clasped about the neck, which might endanger the breaking of the neck.
Holman maneuverHolman described a maneuver with the following steps2:
- perform an episiotomy
- place a finger in the posterior axilla and draw the posterior shoulder down along the pelvic axis
- simultaneously have an assistant perform suprapubic pressure and
- if necessary, insert two supinated fingers under the pubic arch and press and rock the anterior shoulder, tilting the anterior shoulder toward the hollow of the sacrum while simultaneously gently pulling the posterior axilla along the pelvic axis.
Schramm maneuverSchramm, working with a population enriched with women with diabetes, frequently encountered shoulder dystocia and recommended3:
If the posterior axilla can be reached—in other words, if the posterior shoulder is engaged—in my experience it can always be delivered by rotating it to the anterior position while at the same time applying traction....I normally place 1 or 2 fingers of my right hand in the posterior axilla and “scruff” the neck with my left hand, applying both rotation and traction. Because this grip is somewhat insecure, the resultant tractive force is limited and I consider this manoeuvre to be the most effective and least traumatic method of relieving moderate to severe obstruction.
Practice your shoulder dystocia maneuvers using simulation
Obstetric emergencies trigger a rush of adrenaline and great stress for the obstetrician and delivery room team. This may adversely impact motor performance, decision making, and communication skills.1 Low- and high-fidelity simulation exercises create an environment in which the obstetrics team can practice the sequence of maneuvers and seamless teamwork needed to successfully resolve a shoulder dystocia.2,3 Implementing a shoulder dystocia protocol and practicing the protocol using team-based simulation may help to reduce the adverse outcomes of shoulder dystocia.3,4
Reference
1. Wetzel CM, Kneebone RL, Woloshynowych M, et al. The effects of stress on surgical performance. Am J Surg. 2006;191(1):5−10.
2. Crofts JF, Fox R, Ellis D, Winter C, Hinshaw K, Draycott TJ. Observations from 450 shoulder dystocia simulations. Obstet Gynecol. 2008;112(4):906−912.
3. Draycott TJ, Crofts JF, Ash JP, et al. Improving neonatal outcome through practical shoulder dystocia training. Obstet Gynecol. 2008;112(1):14−20.
4. Grobman WA, Miller D, Burke C, Hornbogen A, Tam K, Costello R. Outcomes associated with introduction of a shoulder dystocia protocol. Am J Obstet Gynecol. 2011;205(6):513−517.
Manipulation of the posterior axilla |
|
The right and left third fingers are locked into the posterior axilla, one finger from the front and one from the back of the fetus. Gentle downward guidance is provided by the fingers to draw the posterior shoulder down and out along the curve of the sacrum, thus releasing the anterior shoulder.4 In this drawing, an assistant gently holds the head up. |
Menticoglou maneuverMenticoglou noted that delivery of the posterior arm generally resolves almost all cases of shoulder dystocia. However, if the posterior arm is extended and trapped between the fetus and maternal pelvic side-wall, it may be difficult to deliver the posterior arm. In these cases he recommended having an assistant gently hold, not pull, the fetal head upward and, at the same time, having the obstetrician get on one knee, placing the middle fingers of both hands into the posterior axilla of the fetus.4
The right middle finger is placed into the axilla from the left side of the maternal pelvis, and the left middle finger is placed into the axilla from the right side of the maternal pelvis, resulting in the two middle fingers overlapping in the fetal axilla (FIGURE).4 Gentle force is then used to pull the posterior shoulder and arm downward and outward along the curve of the sacrum. Once the shoulder has emerged from the pelvis, the posterior arm is delivered. Alternatively, if the posterior shoulder is brought well down into the pelvis, another attempt can be made at delivering the posterior arm.4
My preferred approach. The Menticoglou maneuver is my preferred posterior axilla maneuver because it can be accomplished rapidly; requires no equipment, such as a sling catheter; and the obstetrician has good tactile feedback throughout the application of gentle force.
Hofmeyr-Cluver maneuverIn cases of difficult shoulder dystocia, Dr. William Smellie (1762)8 recommended placing one or two fingers in the anterior or posterior fetal axilla and gentling pulling on the axilla to deliver the body. If the axillae were too high to reach, he recommended using a blunt hook in the axilla to draw forth the impacted child. He advised caution when using a blunt hook because the fetus might be injured or lacerated.
Instead of using a hook, Hofmeyr and Cluver5−7 have recommended using a catheter sling to deliver the posterior shoulder. In this maneuver, a loop of a suction catheter or firm urinary catheter is placed over the obstetrician’s index finger and the loop is pushed through the posterior axilla, back to front, with guidance from the index finger. The index finger of the opposite hand is used to catch the loop and pull the catheter through, creating a single-stranded sling that is positioned in the axilla. Gentle force is then applied to the sling in the axis of the pelvis to deliver the posterior shoulder.
“If the posterior arm does not follow it is then swept out easily because room has been created by delivering the posterior shoulder. If the aforementioned procedure fails, the sling can be used to rotate the shoulder. To perform a rotational maneuver, sling traction is directed laterally towards the side of the baby’s back then anteriorly while digital pressure is applied behind the anterior shoulder to assist rotation.”7
Use ACOG’s checklist for documenting a shoulder dystocia
Following the resolution of a shoulder dystocia, it is important to gather all the necessary facts to complete a detailed medical record entry describing the situation and interventions used. The checklist from the American College of Obstetricians and Gynecologists (ACOG) helps you to prepare a standardized medical record entry that is comprehensive.
My experience is that “free form” medical record entries describing the events at a shoulder dystocia event are generally not optimally organized, creating future problems when the case is reviewed.
ACOG obstetric checklists are available for download at http://www.acog.org/Resources-And-Publications, or use your web browser to search for “ACOG Shoulder Dystocia checklist.”
With scant literature, know the benefits and risksThe world’s literature on posterior axilla maneuvers to resolve shoulder dystocia consists of case series and individual case reports.2−7 Hence, the quality of the data supporting this intervention is not optimal, and risks associated with the maneuver are not well characterized. Application of a controlled and gentle force to the posterior axilla may cause fracture of the fetal humerus5 or dislocation of the fetal shoulder. The posterior axilla maneuver also may increase the risk of a maternal third- or fourth-degree perineal laceration.
As a general rule, as the number of maneuvers used to resolve a difficult shoulder dystocia increase, the risk of neonatal injury increases.9 Since the posterior axilla maneuver typically is only attempted after multiple previous maneuvers have failed, the risk of fetal injury is increased. However, as time passes and a shoulder dystocia remains unresolved for 4 or 5 minutes, the risk of neurologic injury and fetal death increases.10
In resolving a shoulder dystocia, speed and skill are essential. A posterior axilla maneuver can be performed more rapidly than a Zavanelli maneuver or a symphysiotomy. Although manipulation of the posterior axilla and arm may cause a fracture of the humerus, this complication is a modest price to pay for preventing permanent fetal brain injury or fetal death.
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.
- Willughby P. Observations in midwifery. New York, NY: MW Books; 1972:312−313.
- Holman MS. A new manoeuvre for delivery of an impacted shoulder based on a mechanical analysis. S Afr Med J. 1963;37:247−249.
- Schramm M. Impacted shoulders—a personal experience. Aust N Z J Obstet Gynaecol. 1983;23(1):28−31.
- Menticoglou SM. A modified technique to deliver the posterior arm in severe shoulder dystocia. Obstet Gynecol. 2006;108(3 pt 2):755−757.
- Cluver CA, Hofmeyr GJ. Posterior axilla sling traction: a technique for intractable shoulder dystocia. Obstet Gynecol. 2009;113(2 pt 2):486–488.
- Hofmeyr GJ, Cluver CA. Posterior axilla sling traction for intractable shoulder dystocia. BJOG. 2009;116(13):1818−1820.
- Cluver CA, Hofmeyr GJ. Posterior axilla sling traction for shoulder dystocia: case review and a new method for shoulder rotation with the sling. Am J Obstet Gynecol. 2015;212(6):784.e1−e7.
- Smellie W. A treatise on the theory and practice of midwifery. 4th ed. London, England; 1762:226−227.
- Hoffman MK, Bailit JL, Branch DW, et al; Consortium on Safe Labor. A comparison of obstetric maneuvers for the acute management of shoulder dystocia. Obstet Gynecol. 2011;117(6):1272−1278.
- Lerner H, Durlacher K, Smith S, Hamilton E. Relationship between head-to-body delivery interval in shoulder dystocia and neonatal depression. Obstet Gynecol. 2011;118(2 pt 1):318−322.
Shoulder dystocia is an unpredictable obstetric emergency that challenges all obstetricians and midwives. In response to a shoulder dystocia emergency, most clinicians implement a sequence of well-practiced steps that begin with early recognition of the problem, clear communication of the emergency with delivery room staff, and a call for help to available clinicians. Management steps may include:
- instructing the mother to stop pushing and moving the mother's buttocks to the edge of the bed
- ensuring there is not a tight nuchal cord
- committing to avoiding the use of excessive force on the fetal head and neck
- considering performing an episiotomy
- performing the McRoberts maneuver combined with suprapubic pressure
- using a rotational maneuver, such as the Woods maneuver or the Rubin maneuver
- delivering the posterior arm
- considering the Gaskin all-four maneuver.
When initial management steps are not enoughIf this sequence of steps does not result in successful vaginal delivery, additional options include: clavicle fracture, cephalic replacement followed by cesarean delivery (Zavanelli maneuver), symphysiotomy, or fundal pressure combined with a rotational maneuver. Another simple intervention that is not discussed widely in medical textbooks or taught during training is the posterior axilla maneuver.
Posterior axilla maneuversVarying posterior axilla maneuvers have been described by many expert obstetricians, including Willughby (17th Century),1 Holman (1963),2 Schramm (1983),3 Menticoglou (2006),4 and Hofmeyr and Cluver (2009, 2015).5−7
Willughby maneuverPercival Willughby’s (1596−1685) description of a posterior axilla maneuver was brief1:
After the head is born, if the child through the greatness of the shoulders, should stick at the neck, let the midwife put her fingers under the child's armpit and give it a nudge, thrusting it to the other side with her finger, drawing the child or she may quickly bring forth the shoulders, without offering to put it forth by her hands clasped about the neck, which might endanger the breaking of the neck.
Holman maneuverHolman described a maneuver with the following steps2:
- perform an episiotomy
- place a finger in the posterior axilla and draw the posterior shoulder down along the pelvic axis
- simultaneously have an assistant perform suprapubic pressure and
- if necessary, insert two supinated fingers under the pubic arch and press and rock the anterior shoulder, tilting the anterior shoulder toward the hollow of the sacrum while simultaneously gently pulling the posterior axilla along the pelvic axis.
Schramm maneuverSchramm, working with a population enriched with women with diabetes, frequently encountered shoulder dystocia and recommended3:
If the posterior axilla can be reached—in other words, if the posterior shoulder is engaged—in my experience it can always be delivered by rotating it to the anterior position while at the same time applying traction....I normally place 1 or 2 fingers of my right hand in the posterior axilla and “scruff” the neck with my left hand, applying both rotation and traction. Because this grip is somewhat insecure, the resultant tractive force is limited and I consider this manoeuvre to be the most effective and least traumatic method of relieving moderate to severe obstruction.
Practice your shoulder dystocia maneuvers using simulation
Obstetric emergencies trigger a rush of adrenaline and great stress for the obstetrician and delivery room team. This may adversely impact motor performance, decision making, and communication skills.1 Low- and high-fidelity simulation exercises create an environment in which the obstetrics team can practice the sequence of maneuvers and seamless teamwork needed to successfully resolve a shoulder dystocia.2,3 Implementing a shoulder dystocia protocol and practicing the protocol using team-based simulation may help to reduce the adverse outcomes of shoulder dystocia.3,4
Reference
1. Wetzel CM, Kneebone RL, Woloshynowych M, et al. The effects of stress on surgical performance. Am J Surg. 2006;191(1):5−10.
2. Crofts JF, Fox R, Ellis D, Winter C, Hinshaw K, Draycott TJ. Observations from 450 shoulder dystocia simulations. Obstet Gynecol. 2008;112(4):906−912.
3. Draycott TJ, Crofts JF, Ash JP, et al. Improving neonatal outcome through practical shoulder dystocia training. Obstet Gynecol. 2008;112(1):14−20.
4. Grobman WA, Miller D, Burke C, Hornbogen A, Tam K, Costello R. Outcomes associated with introduction of a shoulder dystocia protocol. Am J Obstet Gynecol. 2011;205(6):513−517.
Manipulation of the posterior axilla |
|
The right and left third fingers are locked into the posterior axilla, one finger from the front and one from the back of the fetus. Gentle downward guidance is provided by the fingers to draw the posterior shoulder down and out along the curve of the sacrum, thus releasing the anterior shoulder.4 In this drawing, an assistant gently holds the head up. |
Menticoglou maneuverMenticoglou noted that delivery of the posterior arm generally resolves almost all cases of shoulder dystocia. However, if the posterior arm is extended and trapped between the fetus and maternal pelvic side-wall, it may be difficult to deliver the posterior arm. In these cases he recommended having an assistant gently hold, not pull, the fetal head upward and, at the same time, having the obstetrician get on one knee, placing the middle fingers of both hands into the posterior axilla of the fetus.4
The right middle finger is placed into the axilla from the left side of the maternal pelvis, and the left middle finger is placed into the axilla from the right side of the maternal pelvis, resulting in the two middle fingers overlapping in the fetal axilla (FIGURE).4 Gentle force is then used to pull the posterior shoulder and arm downward and outward along the curve of the sacrum. Once the shoulder has emerged from the pelvis, the posterior arm is delivered. Alternatively, if the posterior shoulder is brought well down into the pelvis, another attempt can be made at delivering the posterior arm.4
My preferred approach. The Menticoglou maneuver is my preferred posterior axilla maneuver because it can be accomplished rapidly; requires no equipment, such as a sling catheter; and the obstetrician has good tactile feedback throughout the application of gentle force.
Hofmeyr-Cluver maneuverIn cases of difficult shoulder dystocia, Dr. William Smellie (1762)8 recommended placing one or two fingers in the anterior or posterior fetal axilla and gentling pulling on the axilla to deliver the body. If the axillae were too high to reach, he recommended using a blunt hook in the axilla to draw forth the impacted child. He advised caution when using a blunt hook because the fetus might be injured or lacerated.
Instead of using a hook, Hofmeyr and Cluver5−7 have recommended using a catheter sling to deliver the posterior shoulder. In this maneuver, a loop of a suction catheter or firm urinary catheter is placed over the obstetrician’s index finger and the loop is pushed through the posterior axilla, back to front, with guidance from the index finger. The index finger of the opposite hand is used to catch the loop and pull the catheter through, creating a single-stranded sling that is positioned in the axilla. Gentle force is then applied to the sling in the axis of the pelvis to deliver the posterior shoulder.
“If the posterior arm does not follow it is then swept out easily because room has been created by delivering the posterior shoulder. If the aforementioned procedure fails, the sling can be used to rotate the shoulder. To perform a rotational maneuver, sling traction is directed laterally towards the side of the baby’s back then anteriorly while digital pressure is applied behind the anterior shoulder to assist rotation.”7
Use ACOG’s checklist for documenting a shoulder dystocia
Following the resolution of a shoulder dystocia, it is important to gather all the necessary facts to complete a detailed medical record entry describing the situation and interventions used. The checklist from the American College of Obstetricians and Gynecologists (ACOG) helps you to prepare a standardized medical record entry that is comprehensive.
My experience is that “free form” medical record entries describing the events at a shoulder dystocia event are generally not optimally organized, creating future problems when the case is reviewed.
ACOG obstetric checklists are available for download at http://www.acog.org/Resources-And-Publications, or use your web browser to search for “ACOG Shoulder Dystocia checklist.”
With scant literature, know the benefits and risksThe world’s literature on posterior axilla maneuvers to resolve shoulder dystocia consists of case series and individual case reports.2−7 Hence, the quality of the data supporting this intervention is not optimal, and risks associated with the maneuver are not well characterized. Application of a controlled and gentle force to the posterior axilla may cause fracture of the fetal humerus5 or dislocation of the fetal shoulder. The posterior axilla maneuver also may increase the risk of a maternal third- or fourth-degree perineal laceration.
As a general rule, as the number of maneuvers used to resolve a difficult shoulder dystocia increase, the risk of neonatal injury increases.9 Since the posterior axilla maneuver typically is only attempted after multiple previous maneuvers have failed, the risk of fetal injury is increased. However, as time passes and a shoulder dystocia remains unresolved for 4 or 5 minutes, the risk of neurologic injury and fetal death increases.10
In resolving a shoulder dystocia, speed and skill are essential. A posterior axilla maneuver can be performed more rapidly than a Zavanelli maneuver or a symphysiotomy. Although manipulation of the posterior axilla and arm may cause a fracture of the humerus, this complication is a modest price to pay for preventing permanent fetal brain injury or fetal death.
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.
Shoulder dystocia is an unpredictable obstetric emergency that challenges all obstetricians and midwives. In response to a shoulder dystocia emergency, most clinicians implement a sequence of well-practiced steps that begin with early recognition of the problem, clear communication of the emergency with delivery room staff, and a call for help to available clinicians. Management steps may include:
- instructing the mother to stop pushing and moving the mother's buttocks to the edge of the bed
- ensuring there is not a tight nuchal cord
- committing to avoiding the use of excessive force on the fetal head and neck
- considering performing an episiotomy
- performing the McRoberts maneuver combined with suprapubic pressure
- using a rotational maneuver, such as the Woods maneuver or the Rubin maneuver
- delivering the posterior arm
- considering the Gaskin all-four maneuver.
When initial management steps are not enoughIf this sequence of steps does not result in successful vaginal delivery, additional options include: clavicle fracture, cephalic replacement followed by cesarean delivery (Zavanelli maneuver), symphysiotomy, or fundal pressure combined with a rotational maneuver. Another simple intervention that is not discussed widely in medical textbooks or taught during training is the posterior axilla maneuver.
Posterior axilla maneuversVarying posterior axilla maneuvers have been described by many expert obstetricians, including Willughby (17th Century),1 Holman (1963),2 Schramm (1983),3 Menticoglou (2006),4 and Hofmeyr and Cluver (2009, 2015).5−7
Willughby maneuverPercival Willughby’s (1596−1685) description of a posterior axilla maneuver was brief1:
After the head is born, if the child through the greatness of the shoulders, should stick at the neck, let the midwife put her fingers under the child's armpit and give it a nudge, thrusting it to the other side with her finger, drawing the child or she may quickly bring forth the shoulders, without offering to put it forth by her hands clasped about the neck, which might endanger the breaking of the neck.
Holman maneuverHolman described a maneuver with the following steps2:
- perform an episiotomy
- place a finger in the posterior axilla and draw the posterior shoulder down along the pelvic axis
- simultaneously have an assistant perform suprapubic pressure and
- if necessary, insert two supinated fingers under the pubic arch and press and rock the anterior shoulder, tilting the anterior shoulder toward the hollow of the sacrum while simultaneously gently pulling the posterior axilla along the pelvic axis.
Schramm maneuverSchramm, working with a population enriched with women with diabetes, frequently encountered shoulder dystocia and recommended3:
If the posterior axilla can be reached—in other words, if the posterior shoulder is engaged—in my experience it can always be delivered by rotating it to the anterior position while at the same time applying traction....I normally place 1 or 2 fingers of my right hand in the posterior axilla and “scruff” the neck with my left hand, applying both rotation and traction. Because this grip is somewhat insecure, the resultant tractive force is limited and I consider this manoeuvre to be the most effective and least traumatic method of relieving moderate to severe obstruction.
Practice your shoulder dystocia maneuvers using simulation
Obstetric emergencies trigger a rush of adrenaline and great stress for the obstetrician and delivery room team. This may adversely impact motor performance, decision making, and communication skills.1 Low- and high-fidelity simulation exercises create an environment in which the obstetrics team can practice the sequence of maneuvers and seamless teamwork needed to successfully resolve a shoulder dystocia.2,3 Implementing a shoulder dystocia protocol and practicing the protocol using team-based simulation may help to reduce the adverse outcomes of shoulder dystocia.3,4
Reference
1. Wetzel CM, Kneebone RL, Woloshynowych M, et al. The effects of stress on surgical performance. Am J Surg. 2006;191(1):5−10.
2. Crofts JF, Fox R, Ellis D, Winter C, Hinshaw K, Draycott TJ. Observations from 450 shoulder dystocia simulations. Obstet Gynecol. 2008;112(4):906−912.
3. Draycott TJ, Crofts JF, Ash JP, et al. Improving neonatal outcome through practical shoulder dystocia training. Obstet Gynecol. 2008;112(1):14−20.
4. Grobman WA, Miller D, Burke C, Hornbogen A, Tam K, Costello R. Outcomes associated with introduction of a shoulder dystocia protocol. Am J Obstet Gynecol. 2011;205(6):513−517.
Manipulation of the posterior axilla |
|
The right and left third fingers are locked into the posterior axilla, one finger from the front and one from the back of the fetus. Gentle downward guidance is provided by the fingers to draw the posterior shoulder down and out along the curve of the sacrum, thus releasing the anterior shoulder.4 In this drawing, an assistant gently holds the head up. |
Menticoglou maneuverMenticoglou noted that delivery of the posterior arm generally resolves almost all cases of shoulder dystocia. However, if the posterior arm is extended and trapped between the fetus and maternal pelvic side-wall, it may be difficult to deliver the posterior arm. In these cases he recommended having an assistant gently hold, not pull, the fetal head upward and, at the same time, having the obstetrician get on one knee, placing the middle fingers of both hands into the posterior axilla of the fetus.4
The right middle finger is placed into the axilla from the left side of the maternal pelvis, and the left middle finger is placed into the axilla from the right side of the maternal pelvis, resulting in the two middle fingers overlapping in the fetal axilla (FIGURE).4 Gentle force is then used to pull the posterior shoulder and arm downward and outward along the curve of the sacrum. Once the shoulder has emerged from the pelvis, the posterior arm is delivered. Alternatively, if the posterior shoulder is brought well down into the pelvis, another attempt can be made at delivering the posterior arm.4
My preferred approach. The Menticoglou maneuver is my preferred posterior axilla maneuver because it can be accomplished rapidly; requires no equipment, such as a sling catheter; and the obstetrician has good tactile feedback throughout the application of gentle force.
Hofmeyr-Cluver maneuverIn cases of difficult shoulder dystocia, Dr. William Smellie (1762)8 recommended placing one or two fingers in the anterior or posterior fetal axilla and gentling pulling on the axilla to deliver the body. If the axillae were too high to reach, he recommended using a blunt hook in the axilla to draw forth the impacted child. He advised caution when using a blunt hook because the fetus might be injured or lacerated.
Instead of using a hook, Hofmeyr and Cluver5−7 have recommended using a catheter sling to deliver the posterior shoulder. In this maneuver, a loop of a suction catheter or firm urinary catheter is placed over the obstetrician’s index finger and the loop is pushed through the posterior axilla, back to front, with guidance from the index finger. The index finger of the opposite hand is used to catch the loop and pull the catheter through, creating a single-stranded sling that is positioned in the axilla. Gentle force is then applied to the sling in the axis of the pelvis to deliver the posterior shoulder.
“If the posterior arm does not follow it is then swept out easily because room has been created by delivering the posterior shoulder. If the aforementioned procedure fails, the sling can be used to rotate the shoulder. To perform a rotational maneuver, sling traction is directed laterally towards the side of the baby’s back then anteriorly while digital pressure is applied behind the anterior shoulder to assist rotation.”7
Use ACOG’s checklist for documenting a shoulder dystocia
Following the resolution of a shoulder dystocia, it is important to gather all the necessary facts to complete a detailed medical record entry describing the situation and interventions used. The checklist from the American College of Obstetricians and Gynecologists (ACOG) helps you to prepare a standardized medical record entry that is comprehensive.
My experience is that “free form” medical record entries describing the events at a shoulder dystocia event are generally not optimally organized, creating future problems when the case is reviewed.
ACOG obstetric checklists are available for download at http://www.acog.org/Resources-And-Publications, or use your web browser to search for “ACOG Shoulder Dystocia checklist.”
With scant literature, know the benefits and risksThe world’s literature on posterior axilla maneuvers to resolve shoulder dystocia consists of case series and individual case reports.2−7 Hence, the quality of the data supporting this intervention is not optimal, and risks associated with the maneuver are not well characterized. Application of a controlled and gentle force to the posterior axilla may cause fracture of the fetal humerus5 or dislocation of the fetal shoulder. The posterior axilla maneuver also may increase the risk of a maternal third- or fourth-degree perineal laceration.
As a general rule, as the number of maneuvers used to resolve a difficult shoulder dystocia increase, the risk of neonatal injury increases.9 Since the posterior axilla maneuver typically is only attempted after multiple previous maneuvers have failed, the risk of fetal injury is increased. However, as time passes and a shoulder dystocia remains unresolved for 4 or 5 minutes, the risk of neurologic injury and fetal death increases.10
In resolving a shoulder dystocia, speed and skill are essential. A posterior axilla maneuver can be performed more rapidly than a Zavanelli maneuver or a symphysiotomy. Although manipulation of the posterior axilla and arm may cause a fracture of the humerus, this complication is a modest price to pay for preventing permanent fetal brain injury or fetal death.
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.
- Willughby P. Observations in midwifery. New York, NY: MW Books; 1972:312−313.
- Holman MS. A new manoeuvre for delivery of an impacted shoulder based on a mechanical analysis. S Afr Med J. 1963;37:247−249.
- Schramm M. Impacted shoulders—a personal experience. Aust N Z J Obstet Gynaecol. 1983;23(1):28−31.
- Menticoglou SM. A modified technique to deliver the posterior arm in severe shoulder dystocia. Obstet Gynecol. 2006;108(3 pt 2):755−757.
- Cluver CA, Hofmeyr GJ. Posterior axilla sling traction: a technique for intractable shoulder dystocia. Obstet Gynecol. 2009;113(2 pt 2):486–488.
- Hofmeyr GJ, Cluver CA. Posterior axilla sling traction for intractable shoulder dystocia. BJOG. 2009;116(13):1818−1820.
- Cluver CA, Hofmeyr GJ. Posterior axilla sling traction for shoulder dystocia: case review and a new method for shoulder rotation with the sling. Am J Obstet Gynecol. 2015;212(6):784.e1−e7.
- Smellie W. A treatise on the theory and practice of midwifery. 4th ed. London, England; 1762:226−227.
- Hoffman MK, Bailit JL, Branch DW, et al; Consortium on Safe Labor. A comparison of obstetric maneuvers for the acute management of shoulder dystocia. Obstet Gynecol. 2011;117(6):1272−1278.
- Lerner H, Durlacher K, Smith S, Hamilton E. Relationship between head-to-body delivery interval in shoulder dystocia and neonatal depression. Obstet Gynecol. 2011;118(2 pt 1):318−322.
- Willughby P. Observations in midwifery. New York, NY: MW Books; 1972:312−313.
- Holman MS. A new manoeuvre for delivery of an impacted shoulder based on a mechanical analysis. S Afr Med J. 1963;37:247−249.
- Schramm M. Impacted shoulders—a personal experience. Aust N Z J Obstet Gynaecol. 1983;23(1):28−31.
- Menticoglou SM. A modified technique to deliver the posterior arm in severe shoulder dystocia. Obstet Gynecol. 2006;108(3 pt 2):755−757.
- Cluver CA, Hofmeyr GJ. Posterior axilla sling traction: a technique for intractable shoulder dystocia. Obstet Gynecol. 2009;113(2 pt 2):486–488.
- Hofmeyr GJ, Cluver CA. Posterior axilla sling traction for intractable shoulder dystocia. BJOG. 2009;116(13):1818−1820.
- Cluver CA, Hofmeyr GJ. Posterior axilla sling traction for shoulder dystocia: case review and a new method for shoulder rotation with the sling. Am J Obstet Gynecol. 2015;212(6):784.e1−e7.
- Smellie W. A treatise on the theory and practice of midwifery. 4th ed. London, England; 1762:226−227.
- Hoffman MK, Bailit JL, Branch DW, et al; Consortium on Safe Labor. A comparison of obstetric maneuvers for the acute management of shoulder dystocia. Obstet Gynecol. 2011;117(6):1272−1278.
- Lerner H, Durlacher K, Smith S, Hamilton E. Relationship between head-to-body delivery interval in shoulder dystocia and neonatal depression. Obstet Gynecol. 2011;118(2 pt 1):318−322.
In this article
- Menticoglou maneuver
- Importance of simulation
Goodbye measures of data quantity, hello data quality measures of MACRA
Practicing clinical medicine is increasingly challenging. Besides the onslaught of new clinical information, we have credentialing, accreditation, certification, team-based care, and patient satisfaction that contribute to the complexity of current medical practice. At the heart of many of these challenges is the issue of accountability. Never has our work product as physicians been under such intense scrutiny as it is today.
To demonstrate proof of the care we have provided, we have enlisted a host of administrators, assistants, abstractors, and other helpers to decipher our work and demonstrate its value to professional organizations, boards, hospitals, insurers, and the government. They comb through our charts, decipher our handwriting and dictations, guesstimate our intentions, and sometimes devalue our care because we have not adequately documented what we have done. To solve this accountability problem, our government and the payer community have promoted the electronic health record (EHR) as the “single source of truth” for the care we provide.
This effort received a huge boost in 2009 with the Health Information Technology for Economic and Clinical Health (HITECH) Act. HITECH authorized incentive payments through Medicare and Medicaid to health care providers that could demonstrate Meaningful Use (MU) of a certified EHR. This resulted in a boom in EHR purchases and installations.
By 2012, 71.8% of office-based physicians reported using some type of EHR system, up from 34.8% in 2007.1 In many respects this action was designed as a stimulus for the slow economy, but Congress also wanted some type of accountability that the money spent to subsidize EHR purchases was going to be well spent, and would hopefully have an impact on some of the serious health issues we face.
The initial stage of this MU program seemed to work out reasonably well. So, if a little is good, more must be better, right? Unfortunately, no. But, where did MU go wrong, and how is it being fixed? Contrary to popular belief, MU is not going away, it is being transformed. To help you navigate the tethered landscape of MU past and, more importantly, bring you up to speed on MU future (the Medicare Access and CHIP Reauthorization Act of 2015 [MACRA]) and your payment incentives in this data-centric world, we address MU transformation in this article.
Where Meaningful Use stage 2 went wrong
MU stage 2 turned out to significantly increase the documentation burden on health care professionals. In addition, one of the tragic unintended consequences was that all available EHR development resources by vendors went toward meeting MU data capture requirements rather than to improving the usability and efficiency of the EHRs. Neither result has been well received by health care professionals.
Stage 3 of MU is now in place. It is an attempt to simplify the requirements and focus on quality, safety, interoperability, and patient engagement. See “Meaningful Use stage 3 specifications”. The current progression of MU stages is depicted in TABLE 1.2
Meaningful Use stage 3 specifications
Objective 1: Protect patient health information. Protect electronic health information created or maintained by the Certified Electronic Health Record Technology (CEHRT) through the implementation of appropriate technical, administrative, and physical safeguards.
Objective 2: Electronic prescribing. Eligible providers (EPs) must generate and transmit permissible prescriptions electronically, and eligible hospitals must generate and transmit permissible discharge prescriptions electronically.
Objective 3: Clinical decision support. Implement clinical decision support interventions focused on improving performance on high-priority health conditions.
Objective 4: Computerized provider order entry. Use computerized provider order entry for medication, laboratory, and diagnostic imaging orders directly entered by any licensed health care professional, credentialed medical assistant, or a medical staff member credentialed and performing the equivalent duties of a credentialed medical assistant, who can enter orders into the medical record per state, local, and professional guidelines.
Objective 5: Patient electronic access to health information. The EP provides patients (or patient-authorized representatives) with timely electronic access to their health information and patient-specific education.
Objective 6: Coordination of care through patient engagement. Use the CEHRT to engage with patients or their authorized representatives about the patient's care.
Objective 7: Health information exchange. The EP provides a summary of care record when transitioning or referring their patient to another setting of care, receives or retrieves a summary of care record upon the receipt of a transition or referral or upon the first patient encounter with a new patient, and incorporates summary of care information from other providers into their EHR using the functions of CEHRT.
Objective 8: Public health and clinical data registry reporting. The EP is in active engagement with a public health agency or clinical data registry to submit electronic public health data in a meaningful way using certified EHR technology, except where prohibited, and in accordance with applicable law and practice.
Reference
1. Medicare and Medicaid Programs; Electronic Health Record Incentive Program-Stage 3. Federal Register website. https://www.federalregister.gov/articles/2015/03/30/2015-06685/medicare-and-medicaid-programs-electronic-health-record-incentive-program-stage-3#t-4. Accessed March 19, 2016.
Our new paradigm
Now that EHR implementation is fairly widespread, attention is focused on streamlining the reporting and documentation required for accountability, both from the data entry standpoint and the data analysis standpoint. Discrete data elements, entered by clinicians at the point of care, and downloaded directly from the EHR increasingly will be the way our patient care is assessed. Understanding this new paradigm is critical for both practice and professional viability.
Challenges in this new era
To understand the challenges ahead, we must first take a critical look at how physicians think about documentation, and what changes these models of documentation will have to undergo. Physicians are taught to think in complex models that we document as narratives or stories. While these models are composed of individual “elements” (patient age, due date, hemoglobin value, systolic blood pressure), the real information is in how these elements are related. Understanding a patient, a disease process, or a clinical workflow involves elements that must have context and relationships to be meaningful. Isolated hemoglobin or systolic blood pressure values tell us little, and may in fact obscure the forest for the trees. Physicians want to tell, and understand, the story.
However, an EHR is much more than a collection of narrative text documents. Entering data as discrete elements will allow each data element to be standardized, delegated, automated, analyzed, and monetized. In fact, these processes cannot be accomplished without the data being in this discrete form. While a common complaint about EHRs is that the “story” is hard to decipher, discrete elements are here to stay. Algorithms that can “read” a story and automatically populate these elements (known as natural language processing, or NLP) may someday allow us to go back to our dictations, but that day is frustratingly still far off.
Hello eCQMs
Up to now, physicians have relied on an army of abstractors, coders, billers, quality and safety helpers, and the like to read our notes and supply discrete data to the many clients who want to see accountability for our work. This process of course adds considerable cost to the health care system, and the data collected may not always supply accurate information. The gap between administrative data (gathered from the International Classificationof Diseases Ninth and Tenth revisions and Current Procedural Terminology [copyright American Medical Association] codes) and clinical reality is well documented.3–5
In an attempt to simplify this process, and to create a stronger connection to actual clinical data, the Centers for Medicare and Medicaid Services (CMS)6 is moving toward direct extraction of discrete data that have been entered by health care providers themselves.7 Using clinical data to report on quality metrics allows for improvement in risk adjustment as well as accuracy. Specific measures of this type have been designated eCQMs.
An eCQM is a format for a quality measure, utilizing data entered directly by health care professionals, and extracted directly from the EHR, without the need for additional personnel to review and abstract the chart. eCQMs rapidly are being phased into use for Medicare reimbursement; it is assumed that Medicaid and private payers soon will follow. Instead of payment solely for the quantity of documentation and intervention, we will soon also be paid for the quality of the care we provide (and document). TABLE 2 includes the proposed eCQM reporting timelines for Medicare and Medicaid.2
MACRA
eCQMs are a part of a larger federal effort to reform physician payments—MACRA. Over the past few years, there have been numerous federal programs to measure the quality and appropriateness of care. The Evaluation and Management (E&M) coding guidelines have been supplemented with factors for quality (Physician Quality Reporting System [PQRS]), resource use (the Value-based Payment Modifier), and EHR engagement (MU stages 1, 2, and 3). All of these programs are now being rolled up into a single program under MACRA.
MACRA has 2 distinct parts, known as the Merit-based Incentive Payment System (MIPS) and the Alternative Payment Model. MIPS keeps the underlying fee-for-service model but adds in a factor based on the following metrics:
- clinical quality (which will be based on eCQMs)
- resource use (a gauge of how many economic resources you use in comparison to your peers)
- clinical practice improvement (a measure of how well you are engaged in quality improvement, which includes capturing patient satisfaction data, and being part of a qualified clinical data registry is one way to demonstrate that engagement)
- meaningful use of EHR.
It is important to understand this last bulleted metric: MU is not going away (although that is a popular belief), it is just being transformed into MACRA, with the MU criteria simplified to emphasize a patient-centered medical record. Getting your patients involved through a portal and being able yourself to download, transmit, and accept patients’ data in electronic form are significant parts of MU. Vendors will continue to bear some of this burden, as their requirement to produce systems capable of these functions also increases their accountability.
Measurement and payment incentive
In the MIPS part of MACRA, the 4 factors of clinical quality, resource use, clinical practice improvement, and meaningful use of EHR will be combined in a formula to determine where each practitioner lies in comparison to his or her peers.
Now the bad news: Instead of receiving a bonus by meeting a benchmark, the bonus funds will be subtracted from those providers on the low end of the curve, and given to those at the top end. No matter how well the group does as a whole, no additional money will be available, and the bottom tier will be paying the bonuses of the top tier. The total pool of money to be distributed by CMS in the MIPS program will only grow by 0.5% per year for the foreseeable future. But MACRA does provide an alternative model for reimbursement, the Alternative Payment Model.
Alternative Payment Model
The Alternative Payment Model is basically an Accountable Care Organization—a group of providers agree to meet a certain standard of care (eCQMs again) and, in turn, receive a lump sum of money to deliver that care to a population. If there is some money left over at the end of a year, the group runs a profit. If not, they run a loss. One advantage of this model is that, under MACRA, the pool of money paid to “qualified” groups will increase at 5% per year for the next 5 years. This is certainly a better deal than the 0.5% increase of MIPS.
For specialists in general obstetrics and gynecology it may very well be that the volume of Medicare patients we see will be insufficient to participate meaningfully in either MIPS or the Alternative Payment Model. Regulations are still being crafted to exempt low-volume providers from the burdens associated with MACRA, and the American Congress of Obstetricians and Gynecologists (ACOG) is working diligently to advocate for systems that will allow members to see Medicare patients without requiring the substantial investments these programs likely will require.
The EHR: The single source of truth
The push to make the EHR the single source of truth will streamline many peripheral activities on the health care delivery side as well as the payer side. These requirements will present a new challenge to health care professionals, however. No one went to medical school to become a data entry clerk. Still, EHRs show the promise to transform many aspects of health care delivery. They speed communication,8 reduce errors,9 and may well improve the safety and quality of care. There also is some evidence developing that they may slow the rising cost of health care.10
But they are also quickly becoming a major source of physician dissatisfaction,11 with an apparent dose-response relationship.12 Authors of a recent RAND study note, “the current state of EHR technology significantly worsened professional satisfaction in multiple ways, due to poor usability, time-consuming data entry, interference with face-to-face patient care, inefficient and less fulfilling work content, insufficient health information exchange, and degradation of clinical documentation.”13
This pushback against EHRs has beenheard all the way to Congress. The Senate recently has introduced the ‘‘Improving Health Information Technology Act.’’14 This bill includes proposals for rating EHR systems, decreasing “unnecessary” documentation, prohibiting “information blocking,” and increasing interoperability. It remains to be seen what specific actions will be included, and how this bill will fare in an election year.
So the practice of medicine continues to evolve, and our accountability obligations show no sign of slowing down. The vision of the EHR as a single source of truth—the tool to streamline both the data entry and the data analysis—is being pushed hard by the folks who control the purse strings. This certainly will change the way we conduct our work as physicians and health care professionals. There are innovative efforts being developed to ease this burden. Cloud-based object-oriented data models, independent “apps,” open Application Programming Interfaces, or other technologies may supplant the transactional billing platforms15 we now rely upon.
ACOG is engaged at many levels with these issues, and we will continue to keep the interests of our members and the health of our patients at the center of our efforts. But it seems that, at least for now, a move to capturing discrete data elements and relying on eCQMs for quality measurements will shape the foreseeable payment incentive future.
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.
- Hsiao CJ, Hing E, Ashman J. Trends in electronic health record system use among office-based physicians: United States, 2007–2012. Natl Health Stat Report. 2014;(75):1–18.
- Medicare and Medicaid Programs; Electronic Health Record Incentive Program-Stage 3. Federal Register website. https://www.federalregister.gov/articles/2015/03/30/2015-06685/medicare-and-medicaid-programs-electronic-health-record-incentive-program-stage-3#t-4. Published March 10, 2015. Accessed March 19, 2016.
- Assareh H, Achat HM, Stubbs JM, Guevarra VM, Hill K.Incidence and variation of discrepancies in recording chronic conditions in Australian hospital administrative data. PLoS One. 2016;11(1):e0147087.
- Williams DJ, Shah SS, Myers A, et al. Identifying pediatric community-acquired pneumonia hospitalizations: Accuracy of administrative billing codes. JAMA Pediatr. 2013;167(9):851–858.
- Liede A, Hernandez RK, Roth M, Calkins G, Larrabee K, Nicacio L. Validation of International Classification of Diseases coding for bone metastases in electronic health records using technology-enabled abstraction. Clin Epidemiol. 2015;7:441–448.
- Revisions of Quality Reporting Requirements for Specific Providers, Including Changes Related to the Electronic Health Record Incentive Program. Federal Register website. https://federalregister.gov/a/2015-19049. Published August 17, 2015. Accessed March 19, 2016.
- Panjamapirom A. Hospitals: Electronic CQM Reporting Has Arrived. Are You Ready? http://www.ihealthbeat.org/perspectives/2015/hospitals-electronic-cqm-reporting-has -arrived-are-you-ready. Published August 24, 2015. Accessed March 17, 2016.
- Bernstein PS, Farinelli C, Merkatz IR. Using an electronic medical record to improve communication within a prenatal care network. Obstet Gynecol. 2005;105(3):607–612.
- George J, Bernstein PS. Using electronic medical records to reduce errors and risks in a prenatal network. Curr Opin Obstet Gynecol. 2009;21(6):527–531.
- Adler-Milstein J, Salzberg C, Franz C, Orav EJ, Newhouse JP, Bates DW. Effect of electronic health records on health care costs: longitudinal comparative evidence from community practices. Ann Intern Med. 2013;159(2):97–104.
- Pedulli L. Survey reveals widespread dissatisfaction with EHR systems. http://www.clinical-innovation.com/topics/ehr-emr/survey-reveals-widespread-dissatisfaction-ehr-systems. Published February 11, 2014. Accessed March 17, 2016.
- Babbott S, Manwell LB, Brown R, et al. Electronic medical records and physician stress in primary care: results from the MEMO Study. J Am Med Inform Assoc. 2014;21(e1):e100–e106.
- Friedberg MW, Chen PG, Van Busum KR, et al. Factors affecting physician professional satisfaction and their implications for patient care, health systems, and health policy. RAND Corporation website. http://www.rand.org/pubs/research_reports/RR439.html. Published 2013. Accessed March 17, 2016.
- Majority and Minority Staff of the Senate Committee on Health, Education, Labor, and Pensions. Summary of Improving Health Information Technology Act. http://www.help.senate.gov/imo/media/doc/Improving%20Health%20Information%20Technology%20Act%20--%20Summary.pdf. Accessed March 18, 2016.
- LetDoctorsbeDoctors.com. http://www.letdoctorsbedoctors.com/?sf21392355=1. Published 2016. Accessed March 18, 2016.
Practicing clinical medicine is increasingly challenging. Besides the onslaught of new clinical information, we have credentialing, accreditation, certification, team-based care, and patient satisfaction that contribute to the complexity of current medical practice. At the heart of many of these challenges is the issue of accountability. Never has our work product as physicians been under such intense scrutiny as it is today.
To demonstrate proof of the care we have provided, we have enlisted a host of administrators, assistants, abstractors, and other helpers to decipher our work and demonstrate its value to professional organizations, boards, hospitals, insurers, and the government. They comb through our charts, decipher our handwriting and dictations, guesstimate our intentions, and sometimes devalue our care because we have not adequately documented what we have done. To solve this accountability problem, our government and the payer community have promoted the electronic health record (EHR) as the “single source of truth” for the care we provide.
This effort received a huge boost in 2009 with the Health Information Technology for Economic and Clinical Health (HITECH) Act. HITECH authorized incentive payments through Medicare and Medicaid to health care providers that could demonstrate Meaningful Use (MU) of a certified EHR. This resulted in a boom in EHR purchases and installations.
By 2012, 71.8% of office-based physicians reported using some type of EHR system, up from 34.8% in 2007.1 In many respects this action was designed as a stimulus for the slow economy, but Congress also wanted some type of accountability that the money spent to subsidize EHR purchases was going to be well spent, and would hopefully have an impact on some of the serious health issues we face.
The initial stage of this MU program seemed to work out reasonably well. So, if a little is good, more must be better, right? Unfortunately, no. But, where did MU go wrong, and how is it being fixed? Contrary to popular belief, MU is not going away, it is being transformed. To help you navigate the tethered landscape of MU past and, more importantly, bring you up to speed on MU future (the Medicare Access and CHIP Reauthorization Act of 2015 [MACRA]) and your payment incentives in this data-centric world, we address MU transformation in this article.
Where Meaningful Use stage 2 went wrong
MU stage 2 turned out to significantly increase the documentation burden on health care professionals. In addition, one of the tragic unintended consequences was that all available EHR development resources by vendors went toward meeting MU data capture requirements rather than to improving the usability and efficiency of the EHRs. Neither result has been well received by health care professionals.
Stage 3 of MU is now in place. It is an attempt to simplify the requirements and focus on quality, safety, interoperability, and patient engagement. See “Meaningful Use stage 3 specifications”. The current progression of MU stages is depicted in TABLE 1.2
Meaningful Use stage 3 specifications
Objective 1: Protect patient health information. Protect electronic health information created or maintained by the Certified Electronic Health Record Technology (CEHRT) through the implementation of appropriate technical, administrative, and physical safeguards.
Objective 2: Electronic prescribing. Eligible providers (EPs) must generate and transmit permissible prescriptions electronically, and eligible hospitals must generate and transmit permissible discharge prescriptions electronically.
Objective 3: Clinical decision support. Implement clinical decision support interventions focused on improving performance on high-priority health conditions.
Objective 4: Computerized provider order entry. Use computerized provider order entry for medication, laboratory, and diagnostic imaging orders directly entered by any licensed health care professional, credentialed medical assistant, or a medical staff member credentialed and performing the equivalent duties of a credentialed medical assistant, who can enter orders into the medical record per state, local, and professional guidelines.
Objective 5: Patient electronic access to health information. The EP provides patients (or patient-authorized representatives) with timely electronic access to their health information and patient-specific education.
Objective 6: Coordination of care through patient engagement. Use the CEHRT to engage with patients or their authorized representatives about the patient's care.
Objective 7: Health information exchange. The EP provides a summary of care record when transitioning or referring their patient to another setting of care, receives or retrieves a summary of care record upon the receipt of a transition or referral or upon the first patient encounter with a new patient, and incorporates summary of care information from other providers into their EHR using the functions of CEHRT.
Objective 8: Public health and clinical data registry reporting. The EP is in active engagement with a public health agency or clinical data registry to submit electronic public health data in a meaningful way using certified EHR technology, except where prohibited, and in accordance with applicable law and practice.
Reference
1. Medicare and Medicaid Programs; Electronic Health Record Incentive Program-Stage 3. Federal Register website. https://www.federalregister.gov/articles/2015/03/30/2015-06685/medicare-and-medicaid-programs-electronic-health-record-incentive-program-stage-3#t-4. Accessed March 19, 2016.
Our new paradigm
Now that EHR implementation is fairly widespread, attention is focused on streamlining the reporting and documentation required for accountability, both from the data entry standpoint and the data analysis standpoint. Discrete data elements, entered by clinicians at the point of care, and downloaded directly from the EHR increasingly will be the way our patient care is assessed. Understanding this new paradigm is critical for both practice and professional viability.
Challenges in this new era
To understand the challenges ahead, we must first take a critical look at how physicians think about documentation, and what changes these models of documentation will have to undergo. Physicians are taught to think in complex models that we document as narratives or stories. While these models are composed of individual “elements” (patient age, due date, hemoglobin value, systolic blood pressure), the real information is in how these elements are related. Understanding a patient, a disease process, or a clinical workflow involves elements that must have context and relationships to be meaningful. Isolated hemoglobin or systolic blood pressure values tell us little, and may in fact obscure the forest for the trees. Physicians want to tell, and understand, the story.
However, an EHR is much more than a collection of narrative text documents. Entering data as discrete elements will allow each data element to be standardized, delegated, automated, analyzed, and monetized. In fact, these processes cannot be accomplished without the data being in this discrete form. While a common complaint about EHRs is that the “story” is hard to decipher, discrete elements are here to stay. Algorithms that can “read” a story and automatically populate these elements (known as natural language processing, or NLP) may someday allow us to go back to our dictations, but that day is frustratingly still far off.
Hello eCQMs
Up to now, physicians have relied on an army of abstractors, coders, billers, quality and safety helpers, and the like to read our notes and supply discrete data to the many clients who want to see accountability for our work. This process of course adds considerable cost to the health care system, and the data collected may not always supply accurate information. The gap between administrative data (gathered from the International Classificationof Diseases Ninth and Tenth revisions and Current Procedural Terminology [copyright American Medical Association] codes) and clinical reality is well documented.3–5
In an attempt to simplify this process, and to create a stronger connection to actual clinical data, the Centers for Medicare and Medicaid Services (CMS)6 is moving toward direct extraction of discrete data that have been entered by health care providers themselves.7 Using clinical data to report on quality metrics allows for improvement in risk adjustment as well as accuracy. Specific measures of this type have been designated eCQMs.
An eCQM is a format for a quality measure, utilizing data entered directly by health care professionals, and extracted directly from the EHR, without the need for additional personnel to review and abstract the chart. eCQMs rapidly are being phased into use for Medicare reimbursement; it is assumed that Medicaid and private payers soon will follow. Instead of payment solely for the quantity of documentation and intervention, we will soon also be paid for the quality of the care we provide (and document). TABLE 2 includes the proposed eCQM reporting timelines for Medicare and Medicaid.2
MACRA
eCQMs are a part of a larger federal effort to reform physician payments—MACRA. Over the past few years, there have been numerous federal programs to measure the quality and appropriateness of care. The Evaluation and Management (E&M) coding guidelines have been supplemented with factors for quality (Physician Quality Reporting System [PQRS]), resource use (the Value-based Payment Modifier), and EHR engagement (MU stages 1, 2, and 3). All of these programs are now being rolled up into a single program under MACRA.
MACRA has 2 distinct parts, known as the Merit-based Incentive Payment System (MIPS) and the Alternative Payment Model. MIPS keeps the underlying fee-for-service model but adds in a factor based on the following metrics:
- clinical quality (which will be based on eCQMs)
- resource use (a gauge of how many economic resources you use in comparison to your peers)
- clinical practice improvement (a measure of how well you are engaged in quality improvement, which includes capturing patient satisfaction data, and being part of a qualified clinical data registry is one way to demonstrate that engagement)
- meaningful use of EHR.
It is important to understand this last bulleted metric: MU is not going away (although that is a popular belief), it is just being transformed into MACRA, with the MU criteria simplified to emphasize a patient-centered medical record. Getting your patients involved through a portal and being able yourself to download, transmit, and accept patients’ data in electronic form are significant parts of MU. Vendors will continue to bear some of this burden, as their requirement to produce systems capable of these functions also increases their accountability.
Measurement and payment incentive
In the MIPS part of MACRA, the 4 factors of clinical quality, resource use, clinical practice improvement, and meaningful use of EHR will be combined in a formula to determine where each practitioner lies in comparison to his or her peers.
Now the bad news: Instead of receiving a bonus by meeting a benchmark, the bonus funds will be subtracted from those providers on the low end of the curve, and given to those at the top end. No matter how well the group does as a whole, no additional money will be available, and the bottom tier will be paying the bonuses of the top tier. The total pool of money to be distributed by CMS in the MIPS program will only grow by 0.5% per year for the foreseeable future. But MACRA does provide an alternative model for reimbursement, the Alternative Payment Model.
Alternative Payment Model
The Alternative Payment Model is basically an Accountable Care Organization—a group of providers agree to meet a certain standard of care (eCQMs again) and, in turn, receive a lump sum of money to deliver that care to a population. If there is some money left over at the end of a year, the group runs a profit. If not, they run a loss. One advantage of this model is that, under MACRA, the pool of money paid to “qualified” groups will increase at 5% per year for the next 5 years. This is certainly a better deal than the 0.5% increase of MIPS.
For specialists in general obstetrics and gynecology it may very well be that the volume of Medicare patients we see will be insufficient to participate meaningfully in either MIPS or the Alternative Payment Model. Regulations are still being crafted to exempt low-volume providers from the burdens associated with MACRA, and the American Congress of Obstetricians and Gynecologists (ACOG) is working diligently to advocate for systems that will allow members to see Medicare patients without requiring the substantial investments these programs likely will require.
The EHR: The single source of truth
The push to make the EHR the single source of truth will streamline many peripheral activities on the health care delivery side as well as the payer side. These requirements will present a new challenge to health care professionals, however. No one went to medical school to become a data entry clerk. Still, EHRs show the promise to transform many aspects of health care delivery. They speed communication,8 reduce errors,9 and may well improve the safety and quality of care. There also is some evidence developing that they may slow the rising cost of health care.10
But they are also quickly becoming a major source of physician dissatisfaction,11 with an apparent dose-response relationship.12 Authors of a recent RAND study note, “the current state of EHR technology significantly worsened professional satisfaction in multiple ways, due to poor usability, time-consuming data entry, interference with face-to-face patient care, inefficient and less fulfilling work content, insufficient health information exchange, and degradation of clinical documentation.”13
This pushback against EHRs has beenheard all the way to Congress. The Senate recently has introduced the ‘‘Improving Health Information Technology Act.’’14 This bill includes proposals for rating EHR systems, decreasing “unnecessary” documentation, prohibiting “information blocking,” and increasing interoperability. It remains to be seen what specific actions will be included, and how this bill will fare in an election year.
So the practice of medicine continues to evolve, and our accountability obligations show no sign of slowing down. The vision of the EHR as a single source of truth—the tool to streamline both the data entry and the data analysis—is being pushed hard by the folks who control the purse strings. This certainly will change the way we conduct our work as physicians and health care professionals. There are innovative efforts being developed to ease this burden. Cloud-based object-oriented data models, independent “apps,” open Application Programming Interfaces, or other technologies may supplant the transactional billing platforms15 we now rely upon.
ACOG is engaged at many levels with these issues, and we will continue to keep the interests of our members and the health of our patients at the center of our efforts. But it seems that, at least for now, a move to capturing discrete data elements and relying on eCQMs for quality measurements will shape the foreseeable payment incentive future.
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.
Practicing clinical medicine is increasingly challenging. Besides the onslaught of new clinical information, we have credentialing, accreditation, certification, team-based care, and patient satisfaction that contribute to the complexity of current medical practice. At the heart of many of these challenges is the issue of accountability. Never has our work product as physicians been under such intense scrutiny as it is today.
To demonstrate proof of the care we have provided, we have enlisted a host of administrators, assistants, abstractors, and other helpers to decipher our work and demonstrate its value to professional organizations, boards, hospitals, insurers, and the government. They comb through our charts, decipher our handwriting and dictations, guesstimate our intentions, and sometimes devalue our care because we have not adequately documented what we have done. To solve this accountability problem, our government and the payer community have promoted the electronic health record (EHR) as the “single source of truth” for the care we provide.
This effort received a huge boost in 2009 with the Health Information Technology for Economic and Clinical Health (HITECH) Act. HITECH authorized incentive payments through Medicare and Medicaid to health care providers that could demonstrate Meaningful Use (MU) of a certified EHR. This resulted in a boom in EHR purchases and installations.
By 2012, 71.8% of office-based physicians reported using some type of EHR system, up from 34.8% in 2007.1 In many respects this action was designed as a stimulus for the slow economy, but Congress also wanted some type of accountability that the money spent to subsidize EHR purchases was going to be well spent, and would hopefully have an impact on some of the serious health issues we face.
The initial stage of this MU program seemed to work out reasonably well. So, if a little is good, more must be better, right? Unfortunately, no. But, where did MU go wrong, and how is it being fixed? Contrary to popular belief, MU is not going away, it is being transformed. To help you navigate the tethered landscape of MU past and, more importantly, bring you up to speed on MU future (the Medicare Access and CHIP Reauthorization Act of 2015 [MACRA]) and your payment incentives in this data-centric world, we address MU transformation in this article.
Where Meaningful Use stage 2 went wrong
MU stage 2 turned out to significantly increase the documentation burden on health care professionals. In addition, one of the tragic unintended consequences was that all available EHR development resources by vendors went toward meeting MU data capture requirements rather than to improving the usability and efficiency of the EHRs. Neither result has been well received by health care professionals.
Stage 3 of MU is now in place. It is an attempt to simplify the requirements and focus on quality, safety, interoperability, and patient engagement. See “Meaningful Use stage 3 specifications”. The current progression of MU stages is depicted in TABLE 1.2
Meaningful Use stage 3 specifications
Objective 1: Protect patient health information. Protect electronic health information created or maintained by the Certified Electronic Health Record Technology (CEHRT) through the implementation of appropriate technical, administrative, and physical safeguards.
Objective 2: Electronic prescribing. Eligible providers (EPs) must generate and transmit permissible prescriptions electronically, and eligible hospitals must generate and transmit permissible discharge prescriptions electronically.
Objective 3: Clinical decision support. Implement clinical decision support interventions focused on improving performance on high-priority health conditions.
Objective 4: Computerized provider order entry. Use computerized provider order entry for medication, laboratory, and diagnostic imaging orders directly entered by any licensed health care professional, credentialed medical assistant, or a medical staff member credentialed and performing the equivalent duties of a credentialed medical assistant, who can enter orders into the medical record per state, local, and professional guidelines.
Objective 5: Patient electronic access to health information. The EP provides patients (or patient-authorized representatives) with timely electronic access to their health information and patient-specific education.
Objective 6: Coordination of care through patient engagement. Use the CEHRT to engage with patients or their authorized representatives about the patient's care.
Objective 7: Health information exchange. The EP provides a summary of care record when transitioning or referring their patient to another setting of care, receives or retrieves a summary of care record upon the receipt of a transition or referral or upon the first patient encounter with a new patient, and incorporates summary of care information from other providers into their EHR using the functions of CEHRT.
Objective 8: Public health and clinical data registry reporting. The EP is in active engagement with a public health agency or clinical data registry to submit electronic public health data in a meaningful way using certified EHR technology, except where prohibited, and in accordance with applicable law and practice.
Reference
1. Medicare and Medicaid Programs; Electronic Health Record Incentive Program-Stage 3. Federal Register website. https://www.federalregister.gov/articles/2015/03/30/2015-06685/medicare-and-medicaid-programs-electronic-health-record-incentive-program-stage-3#t-4. Accessed March 19, 2016.
Our new paradigm
Now that EHR implementation is fairly widespread, attention is focused on streamlining the reporting and documentation required for accountability, both from the data entry standpoint and the data analysis standpoint. Discrete data elements, entered by clinicians at the point of care, and downloaded directly from the EHR increasingly will be the way our patient care is assessed. Understanding this new paradigm is critical for both practice and professional viability.
Challenges in this new era
To understand the challenges ahead, we must first take a critical look at how physicians think about documentation, and what changes these models of documentation will have to undergo. Physicians are taught to think in complex models that we document as narratives or stories. While these models are composed of individual “elements” (patient age, due date, hemoglobin value, systolic blood pressure), the real information is in how these elements are related. Understanding a patient, a disease process, or a clinical workflow involves elements that must have context and relationships to be meaningful. Isolated hemoglobin or systolic blood pressure values tell us little, and may in fact obscure the forest for the trees. Physicians want to tell, and understand, the story.
However, an EHR is much more than a collection of narrative text documents. Entering data as discrete elements will allow each data element to be standardized, delegated, automated, analyzed, and monetized. In fact, these processes cannot be accomplished without the data being in this discrete form. While a common complaint about EHRs is that the “story” is hard to decipher, discrete elements are here to stay. Algorithms that can “read” a story and automatically populate these elements (known as natural language processing, or NLP) may someday allow us to go back to our dictations, but that day is frustratingly still far off.
Hello eCQMs
Up to now, physicians have relied on an army of abstractors, coders, billers, quality and safety helpers, and the like to read our notes and supply discrete data to the many clients who want to see accountability for our work. This process of course adds considerable cost to the health care system, and the data collected may not always supply accurate information. The gap between administrative data (gathered from the International Classificationof Diseases Ninth and Tenth revisions and Current Procedural Terminology [copyright American Medical Association] codes) and clinical reality is well documented.3–5
In an attempt to simplify this process, and to create a stronger connection to actual clinical data, the Centers for Medicare and Medicaid Services (CMS)6 is moving toward direct extraction of discrete data that have been entered by health care providers themselves.7 Using clinical data to report on quality metrics allows for improvement in risk adjustment as well as accuracy. Specific measures of this type have been designated eCQMs.
An eCQM is a format for a quality measure, utilizing data entered directly by health care professionals, and extracted directly from the EHR, without the need for additional personnel to review and abstract the chart. eCQMs rapidly are being phased into use for Medicare reimbursement; it is assumed that Medicaid and private payers soon will follow. Instead of payment solely for the quantity of documentation and intervention, we will soon also be paid for the quality of the care we provide (and document). TABLE 2 includes the proposed eCQM reporting timelines for Medicare and Medicaid.2
MACRA
eCQMs are a part of a larger federal effort to reform physician payments—MACRA. Over the past few years, there have been numerous federal programs to measure the quality and appropriateness of care. The Evaluation and Management (E&M) coding guidelines have been supplemented with factors for quality (Physician Quality Reporting System [PQRS]), resource use (the Value-based Payment Modifier), and EHR engagement (MU stages 1, 2, and 3). All of these programs are now being rolled up into a single program under MACRA.
MACRA has 2 distinct parts, known as the Merit-based Incentive Payment System (MIPS) and the Alternative Payment Model. MIPS keeps the underlying fee-for-service model but adds in a factor based on the following metrics:
- clinical quality (which will be based on eCQMs)
- resource use (a gauge of how many economic resources you use in comparison to your peers)
- clinical practice improvement (a measure of how well you are engaged in quality improvement, which includes capturing patient satisfaction data, and being part of a qualified clinical data registry is one way to demonstrate that engagement)
- meaningful use of EHR.
It is important to understand this last bulleted metric: MU is not going away (although that is a popular belief), it is just being transformed into MACRA, with the MU criteria simplified to emphasize a patient-centered medical record. Getting your patients involved through a portal and being able yourself to download, transmit, and accept patients’ data in electronic form are significant parts of MU. Vendors will continue to bear some of this burden, as their requirement to produce systems capable of these functions also increases their accountability.
Measurement and payment incentive
In the MIPS part of MACRA, the 4 factors of clinical quality, resource use, clinical practice improvement, and meaningful use of EHR will be combined in a formula to determine where each practitioner lies in comparison to his or her peers.
Now the bad news: Instead of receiving a bonus by meeting a benchmark, the bonus funds will be subtracted from those providers on the low end of the curve, and given to those at the top end. No matter how well the group does as a whole, no additional money will be available, and the bottom tier will be paying the bonuses of the top tier. The total pool of money to be distributed by CMS in the MIPS program will only grow by 0.5% per year for the foreseeable future. But MACRA does provide an alternative model for reimbursement, the Alternative Payment Model.
Alternative Payment Model
The Alternative Payment Model is basically an Accountable Care Organization—a group of providers agree to meet a certain standard of care (eCQMs again) and, in turn, receive a lump sum of money to deliver that care to a population. If there is some money left over at the end of a year, the group runs a profit. If not, they run a loss. One advantage of this model is that, under MACRA, the pool of money paid to “qualified” groups will increase at 5% per year for the next 5 years. This is certainly a better deal than the 0.5% increase of MIPS.
For specialists in general obstetrics and gynecology it may very well be that the volume of Medicare patients we see will be insufficient to participate meaningfully in either MIPS or the Alternative Payment Model. Regulations are still being crafted to exempt low-volume providers from the burdens associated with MACRA, and the American Congress of Obstetricians and Gynecologists (ACOG) is working diligently to advocate for systems that will allow members to see Medicare patients without requiring the substantial investments these programs likely will require.
The EHR: The single source of truth
The push to make the EHR the single source of truth will streamline many peripheral activities on the health care delivery side as well as the payer side. These requirements will present a new challenge to health care professionals, however. No one went to medical school to become a data entry clerk. Still, EHRs show the promise to transform many aspects of health care delivery. They speed communication,8 reduce errors,9 and may well improve the safety and quality of care. There also is some evidence developing that they may slow the rising cost of health care.10
But they are also quickly becoming a major source of physician dissatisfaction,11 with an apparent dose-response relationship.12 Authors of a recent RAND study note, “the current state of EHR technology significantly worsened professional satisfaction in multiple ways, due to poor usability, time-consuming data entry, interference with face-to-face patient care, inefficient and less fulfilling work content, insufficient health information exchange, and degradation of clinical documentation.”13
This pushback against EHRs has beenheard all the way to Congress. The Senate recently has introduced the ‘‘Improving Health Information Technology Act.’’14 This bill includes proposals for rating EHR systems, decreasing “unnecessary” documentation, prohibiting “information blocking,” and increasing interoperability. It remains to be seen what specific actions will be included, and how this bill will fare in an election year.
So the practice of medicine continues to evolve, and our accountability obligations show no sign of slowing down. The vision of the EHR as a single source of truth—the tool to streamline both the data entry and the data analysis—is being pushed hard by the folks who control the purse strings. This certainly will change the way we conduct our work as physicians and health care professionals. There are innovative efforts being developed to ease this burden. Cloud-based object-oriented data models, independent “apps,” open Application Programming Interfaces, or other technologies may supplant the transactional billing platforms15 we now rely upon.
ACOG is engaged at many levels with these issues, and we will continue to keep the interests of our members and the health of our patients at the center of our efforts. But it seems that, at least for now, a move to capturing discrete data elements and relying on eCQMs for quality measurements will shape the foreseeable payment incentive future.
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.
- Hsiao CJ, Hing E, Ashman J. Trends in electronic health record system use among office-based physicians: United States, 2007–2012. Natl Health Stat Report. 2014;(75):1–18.
- Medicare and Medicaid Programs; Electronic Health Record Incentive Program-Stage 3. Federal Register website. https://www.federalregister.gov/articles/2015/03/30/2015-06685/medicare-and-medicaid-programs-electronic-health-record-incentive-program-stage-3#t-4. Published March 10, 2015. Accessed March 19, 2016.
- Assareh H, Achat HM, Stubbs JM, Guevarra VM, Hill K.Incidence and variation of discrepancies in recording chronic conditions in Australian hospital administrative data. PLoS One. 2016;11(1):e0147087.
- Williams DJ, Shah SS, Myers A, et al. Identifying pediatric community-acquired pneumonia hospitalizations: Accuracy of administrative billing codes. JAMA Pediatr. 2013;167(9):851–858.
- Liede A, Hernandez RK, Roth M, Calkins G, Larrabee K, Nicacio L. Validation of International Classification of Diseases coding for bone metastases in electronic health records using technology-enabled abstraction. Clin Epidemiol. 2015;7:441–448.
- Revisions of Quality Reporting Requirements for Specific Providers, Including Changes Related to the Electronic Health Record Incentive Program. Federal Register website. https://federalregister.gov/a/2015-19049. Published August 17, 2015. Accessed March 19, 2016.
- Panjamapirom A. Hospitals: Electronic CQM Reporting Has Arrived. Are You Ready? http://www.ihealthbeat.org/perspectives/2015/hospitals-electronic-cqm-reporting-has -arrived-are-you-ready. Published August 24, 2015. Accessed March 17, 2016.
- Bernstein PS, Farinelli C, Merkatz IR. Using an electronic medical record to improve communication within a prenatal care network. Obstet Gynecol. 2005;105(3):607–612.
- George J, Bernstein PS. Using electronic medical records to reduce errors and risks in a prenatal network. Curr Opin Obstet Gynecol. 2009;21(6):527–531.
- Adler-Milstein J, Salzberg C, Franz C, Orav EJ, Newhouse JP, Bates DW. Effect of electronic health records on health care costs: longitudinal comparative evidence from community practices. Ann Intern Med. 2013;159(2):97–104.
- Pedulli L. Survey reveals widespread dissatisfaction with EHR systems. http://www.clinical-innovation.com/topics/ehr-emr/survey-reveals-widespread-dissatisfaction-ehr-systems. Published February 11, 2014. Accessed March 17, 2016.
- Babbott S, Manwell LB, Brown R, et al. Electronic medical records and physician stress in primary care: results from the MEMO Study. J Am Med Inform Assoc. 2014;21(e1):e100–e106.
- Friedberg MW, Chen PG, Van Busum KR, et al. Factors affecting physician professional satisfaction and their implications for patient care, health systems, and health policy. RAND Corporation website. http://www.rand.org/pubs/research_reports/RR439.html. Published 2013. Accessed March 17, 2016.
- Majority and Minority Staff of the Senate Committee on Health, Education, Labor, and Pensions. Summary of Improving Health Information Technology Act. http://www.help.senate.gov/imo/media/doc/Improving%20Health%20Information%20Technology%20Act%20--%20Summary.pdf. Accessed March 18, 2016.
- LetDoctorsbeDoctors.com. http://www.letdoctorsbedoctors.com/?sf21392355=1. Published 2016. Accessed March 18, 2016.
- Hsiao CJ, Hing E, Ashman J. Trends in electronic health record system use among office-based physicians: United States, 2007–2012. Natl Health Stat Report. 2014;(75):1–18.
- Medicare and Medicaid Programs; Electronic Health Record Incentive Program-Stage 3. Federal Register website. https://www.federalregister.gov/articles/2015/03/30/2015-06685/medicare-and-medicaid-programs-electronic-health-record-incentive-program-stage-3#t-4. Published March 10, 2015. Accessed March 19, 2016.
- Assareh H, Achat HM, Stubbs JM, Guevarra VM, Hill K.Incidence and variation of discrepancies in recording chronic conditions in Australian hospital administrative data. PLoS One. 2016;11(1):e0147087.
- Williams DJ, Shah SS, Myers A, et al. Identifying pediatric community-acquired pneumonia hospitalizations: Accuracy of administrative billing codes. JAMA Pediatr. 2013;167(9):851–858.
- Liede A, Hernandez RK, Roth M, Calkins G, Larrabee K, Nicacio L. Validation of International Classification of Diseases coding for bone metastases in electronic health records using technology-enabled abstraction. Clin Epidemiol. 2015;7:441–448.
- Revisions of Quality Reporting Requirements for Specific Providers, Including Changes Related to the Electronic Health Record Incentive Program. Federal Register website. https://federalregister.gov/a/2015-19049. Published August 17, 2015. Accessed March 19, 2016.
- Panjamapirom A. Hospitals: Electronic CQM Reporting Has Arrived. Are You Ready? http://www.ihealthbeat.org/perspectives/2015/hospitals-electronic-cqm-reporting-has -arrived-are-you-ready. Published August 24, 2015. Accessed March 17, 2016.
- Bernstein PS, Farinelli C, Merkatz IR. Using an electronic medical record to improve communication within a prenatal care network. Obstet Gynecol. 2005;105(3):607–612.
- George J, Bernstein PS. Using electronic medical records to reduce errors and risks in a prenatal network. Curr Opin Obstet Gynecol. 2009;21(6):527–531.
- Adler-Milstein J, Salzberg C, Franz C, Orav EJ, Newhouse JP, Bates DW. Effect of electronic health records on health care costs: longitudinal comparative evidence from community practices. Ann Intern Med. 2013;159(2):97–104.
- Pedulli L. Survey reveals widespread dissatisfaction with EHR systems. http://www.clinical-innovation.com/topics/ehr-emr/survey-reveals-widespread-dissatisfaction-ehr-systems. Published February 11, 2014. Accessed March 17, 2016.
- Babbott S, Manwell LB, Brown R, et al. Electronic medical records and physician stress in primary care: results from the MEMO Study. J Am Med Inform Assoc. 2014;21(e1):e100–e106.
- Friedberg MW, Chen PG, Van Busum KR, et al. Factors affecting physician professional satisfaction and their implications for patient care, health systems, and health policy. RAND Corporation website. http://www.rand.org/pubs/research_reports/RR439.html. Published 2013. Accessed March 17, 2016.
- Majority and Minority Staff of the Senate Committee on Health, Education, Labor, and Pensions. Summary of Improving Health Information Technology Act. http://www.help.senate.gov/imo/media/doc/Improving%20Health%20Information%20Technology%20Act%20--%20Summary.pdf. Accessed March 18, 2016.
- LetDoctorsbeDoctors.com. http://www.letdoctorsbedoctors.com/?sf21392355=1. Published 2016. Accessed March 18, 2016.
The crushing of innovation for treating female pelvic floor disorders: A story of “lead or be led”
With the decision by Astora Women’s Health to discontinue operations as of March 31, 2016, we have lost midurethral slings and pelvic organ prolapse repair mesh, technologies and kits that have been among the most widely used and studied (Steve Blum, Senior Vice President and General Manager, Astora Women’s Health, and Kathie J. Lenzen, Senior Vice President and General Manager, Endo Device Operations, e-mail communication to physician customers, February 29, 2016). US Food and Drug Administration (FDA)−mandated 522 postmarket surveillance studies on these products have stopped enrolling patients, and we will therefore never glean the full science from fully enrolled and completed studies. This is a horrible precedent. How did this happen, and what do we need to do now to prevent further loss of helpful innovative technologies that benefit our patients with pelvic floor disorders?
Liability challenges precipitated shut downEndo Pharmaceuticals, the parent company of Astora (previously American Medical Systems Women’s Health division), last year offered $1.5 billion to settle a majority of its pending mesh litigation cases. I was told that the company wanted to put all of the negative noise from the relentless plaintiff attorney public media campaign behind it and refocus its attention on helping women with pelvic floor disorders.
Over the past year, 4 interested and capable buyers have been in discussions with the company to purchase and continue its product line. The company’s recent decision to not sell its product line and discontinue all operations was based on “the current legal environment and the ongoing challenges associated with vaginal mesh product liability” (Astora Women’s Health, e-mail communication to physician customers, February 29, 2016). If it had chosen to sell its product line, the company always would have remained a potential deep-pocketed codefendant in any future litigation against the company that purchased its products, technologies, and intellectual properties.
This is a frightening scenario that threatens existing companies that want to remain in the prolapse and incontinence product space. This is a threat to all future innovation for pelvic floor disorder therapies, and it discourages anyone or any company to invest in innovative products that may help our patients. In addition, it is a threat to our mission as physicians and surgeons to provide the very best therapies to our patients who deserve and expect us to do so.
Let me be crystal clear: Currently available midurethral slings are also in the crosshairs of plaintiff attorneys, and we are at risk of losing them as well if we do not act quickly, decisively, and as a unified force. More than 60% of the mesh lawsuits have been against midurethral slings, not the prolapse mesh kits focused on in the FDA Public Health notice of July 2011.1 In their class action lawsuits, plaintiff attorneys lumped together any procedure involving mesh in the pelvis to increase the number of their patient clients involved, which can drive up settlement awards, and they succeeded. In 2014, 128,030 sling procedures for incontinence were performed. Does anyone truly believe that the scientific literature supports that these patients would have been best served by 128,030 Burch procedures?
Some believe that Endo Pharmaceuticals’ placement of $1.5 billion in settlement funds was an error, “threw blood in the water,” and led to what has happened. Some believe that companies should fight every lawsuit to win and not settle. By the companies winning cases, the plaintiff attorneys lose their incentives to advertise and file more cases, as they only receive money if they win (or get a settlement) and are out of pocket for their costs and time if they lose.
Plaintiff attorneys have a responsibility to zealously advocate for their patient clients. Defense attorneys have a responsibility to zealously defend their corporate clients. We surgeons must realize that we have a responsibility to zealously advocate for our patients and do whatever is needed to best serve them and to protect the use (and development) of innovative products and therapies that give them value and a better quality of life.
Proactive steps surgeons can take
How do we do this? I suggest the following:
Implement expert oversight for litigation. Some of the large plaintiff awards were assisted by expert testimony based on a highly questionable scientific foundation. Judges give expert witnesses great latitude in their testimony, relying on the jury to discern the truth. I recommend that professional societies, such as the American College of Obstetricians and Gynecologists (ACOG), AmericanUrological Association (AUA), American Urogynecologic Society (AUGS), Society of Urodynamics, Female Pelvic Medicine & Urogenital Reconstruction (SUFU), and Society of Gynecologic Surgeons (SGS), establish a panel to review and carefully evaluate plaintiff expert testimony that has a questionable scientific foundation. If such a panel finds the scientific basis of testimony to be biased, untruthful, or unethical, the societies must publicly reprimand and sanction these experts. Only then would these experts no longer be used by the plaintiff attorneys.
Such an expert panel also could serve to educate the judges in federal and state courts on real science and not manufactured opinions.
We need juries that can understand the science so they truly can decide on cases involving complex technologies.
Support professional leadership efforts. I am encouraged that AUGS is working to establish guidelines for the management of mesh complications. I have seen cases in which a small amount of mesh exposure, best treated by limited local excision of the exposed mesh, instead has been treated by complete excision of every polypropylene fiber placed, resulting in an unnecessarily morbid surgery that leaves a scarred and small vagina. Notably, some of the surgeons who excise every polypropylene fiber are also working as plaintiff experts, who may then testify that the scarred, small vagina was caused by the mesh and the implanting surgeon.
Our professional society leadership and volunteer committees, especially from AUGS, have done a tremendous amount of work in assisting with the FDA-required 522 postmarket surveillance study research design; establishing a Pelvic Floor Disorders Registry (http://www.pfdr.org/) and a sling registry; and developing credentialing guidelines for sacrocolpopexy, transvaginal mesh, and slings. They deserve our gratitude and our participation in the registries. It would be a tragedy if all of this work does not lead to fully enrolled and completed 522 studies so that we can scientifically make decisions on products before any more treatment options are removed from the market.
Use video to scrutinize surgical outcomes data. The surgical literature shows extreme variance in outcomes and complications for vaginal mesh surgery, including exposure rates from 1% to 20% with the same mesh products. This only can be explained by depth of surgical dissection and implanting technique. Surgical outcomes have been shown to be related directly to surgical volumes and experience.2 I propose that going forward, any authors who publish their study outcomes and complication data on a surgical procedure must submit a surgical video that demonstrates exactly how the surgery was done.
Best serve the patient. We all need to rigorously follow our own surgery results, improve our techniques, and keep within our surgical skill sets. We need to share our outcome and complication data with our patients during the informed consent process, since we, and not the surgical literature, are performing their surgeries.
We need to be transparent and respectful of our colleagues with different skill sets, putting what is best for patients ahead of everything else. We must be mindful of our inherent biases toward surgeries we are personally very good at and comfortable with. We must respect that other surgeons may achieve better clinical outcomes than us with the same surgery. We need to teach each other the best reproducible surgical techniques to maximize outcomes and minimize complications.
We must humbly accept that not every surgeon can do every surgery (and should not try). If a patient would be best served with a surgery we are not skilled in, we must refer that patient to a colleague who is.
Encourage industry’s part in training. As new technologies are developed, we must be brutally honest with ourselves about whether or not we have the skill sets to use them. Industry must gauge the complexity of the surgical skill set necessary to use their products and limit attendance at their teaching labs to surgeons who have the skills required to obtain good outcomes and minimize complications.
We have reached the tipping pointWe have seen the enemy, and it is us. We now need to advocate zealously for our patients. We will succeed only if we keep what is best for our patients at the forefront of everything we do. We must today decide to lead or be led. If we do not lead, we will be led by others—to places that may not best serve our patients. Make no mistake, this is a tipping point. The future of midurethral slings and potential future innovations lie in our hands right now.
Notably, just days prior to Astora’s letter to its physician customers announcing the decision to discontinue all of its operations, the transobturator postanal sling system (TOPAS) for fecal incontinence, a product in the pipeline at Astora, received 3 unanimous 8-0 votes from an FDA device advisory panel on safety, efficacy, and benefit outweighing risk.3 The future of this technology is now uncertain as well.
I ask Endo Pharmaceuticals to reconsider abandoning all of its products and intellectual properties. I ask it to entertain discussions with large companies that want its technologies and intellectual properties and can indemnify it from future litigation. While there never is a guarantee of complete indemnification and the company does have a fiduciary responsibility to its shareholders, industry also has a responsibility to patients and surgeons to allow helpful technologies to persist.
According to Astora’s letter to its physician customers, “Patient health has always been our number one priority. As such, the business closure has been expedited so that you and your patients have the opportunity to assess alternative treatment options as soon as possible.”
That letter was dated February 29. I do not feel that 31 days’ notice is enough time for surgeons to assess—let alone learn and master—new treatment options. It would have been helpful if Endo Pharmaceuticals had given more notice and would at least have allowed other interested companies the option to purchase useful technologies and intellectual property to mitigate its rapid departure from the space. The company remains in the health care arena with its pharmaceutical products, and how it behaves leaving the surgical space will be noted and impact its brand and reputation.
Lessons from the morcellation situationHow quickly the power morcellator disappeared is a lesson to note very carefully, and it has important parallels to what we now face. I highly recommend that you read and study Lisa Rosenbaum’s article in New England Journal of Medicine, “N-of-1 policymaking—tragedy, trade-offs, and the demise of morcellation.”4 She eloquently discusses how decisions to terminate technologies based on passionate anecdotal stories and media campaigns, and not scientific study, does not serve the greater good. She explores lessons learned from the silicone breast implant saga as well, stating “the tendency to focus on eliminating an immediate harm while failing to consider potentially greater harms caused by that reaction is heightened by the power of tragic stories.”4
We need a calmer, less emotional, and balanced scientific approach to evaluate technologies. We need to consider what harm is done by not allowing new technologies to be adequately studied, improved, and implemented. Dr. Rosenbaum discusses what Cass Sunstein and Timur Kuran call the “availability cascade,” “a phenomenon whereby stories inform public perceptions and anyone challenging those perceptions is vilified.”4,5
No technology will ever be risk free, and there always will be some risks and complications that could be significant and chilling. However, patient autonomy requires a full discussion of a risk/benefit ratio that is based on science, and these scientific data must be allowed to be collected and learned. There even can be more significant and chilling complications from not using a technology as well.
It is challenging to speak science to emotion that is driven by tragic outcomes, but we can remain compassionate as we seek the science that will serve the greater good. Condemning proponents of carefully studied and properly implemented technologies as immoral is neither helpful nor constructive. Crushing the ability to thoroughly and scientifically study new technologies is not in the best interest of our patients with pelvic floor disorders.
It is time to reawaken the better angels of our natureWill we do the necessary work now no matter how uncomfortable it may make us feel? Or will we be intimidated and remain silent and disjointed? Will we participate in the registries and follow best clinical practice and credentialing guidelines? Will we hold ourselves and our colleagues accountable? It is time to remember why we became surgeons, and to start acting on our convictions.
To that end, we must ask ourselves, will we:
- honor the Hippocratic Oath that we took in medical school and “respect the hard-won scientific gains of those physicians in whose steps I walk, and gladly share such knowledge as is mine with those who are to follow”6
- “not be ashamed to say ‘I know not,’ nor will I fail to call in my colleagues when the skills of another are needed for a patient’s recovery”6
- zealously advocate for our patients to ensure we can offer them the very best therapies
- honor and respect the sacred trust patients place in us when we take them to the operating room
- lead or be led?
This is personal for me. My mother struggled with pelvic floor disorders. I always felt it grossly unfair that women who chose to give us life could suffer for the rest of theirs for that decision. These women deserve our very best. The 40 million women with pelvic floor disorders deserve—and expect—that we lead. Will we?
I am hopeful that we will. I believe we will rise to today’s challenges and protect and fight for our patients. I believe that years from now we will look back and be proud that we did the right thing, and in so doing protected and encouraged innovations that significantly enhanced the quality of our patients’ lives. I believe patients will recognize our genuine efforts and in so doing give our profession the respect and trust that I feel has been diminished.
I believe we will draw the needed courage and resolve from the oath we recited in medical school and remember that, “If I do not violate this oath, may I enjoy life and art, respected while I live and remembered with affection thereafter. May I always act so as to preserve the finest traditions of my calling and may I long experience the joy of healing those who seek my help.”6
I do believe we will.
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.
- Food and Drug Administration. Urogynecologic surgical mesh: update on the safety and effectiveness of transvaginal placement for pelvic organ prolapse. http://www.fda.gov/downloads/MedicalDevices/Safety/AlertsandNotices/UCM262760.pdf. Published July 2011. Accessed March 21, 2016.
- Meyer CP, Trinh QD. Complications after surgery for stress urinary incontinence: untangling a mesh of uncertainties. JAMA Surg. 2015;150(12):1175-1176.
- Food and Drug Administration Center for Devices and Radiological Health. Brief summary of the Gastroenterology and Urology Devices Panel of the Medical Devices Advisory Committee Meeting--February 25, 2016. http://www.fda.gov/downloads/AdvisoryCommittees/CommitteesMeetingMaterials/MedicalDevices/MedicalDevicesAdvisoryCommittee/Gastroenterology-UrologyDevicesPanel/UCM488397.pdf. Accessed March 21, 2016.
- Rosenbaum L. N-of-1--tragedy, trade-offs, and the demise of morcellation. N Engl J Med. 2016;374(10):986-990.
- Kuran T, Sunstein C. Availability cascades and risk regulation. Stanford Law Rev. 1999;51:683-768.
- Hippocratic oath, modern version. Adapted by Louis Lasagna. 1964. Johns Hopkins Sheridan Libraries and University Museums website. http://guides.library.jhu.edu/c.php?g=202502&p=1335759. Updated December 8, 2015. Accessed March 22, 2016.
With the decision by Astora Women’s Health to discontinue operations as of March 31, 2016, we have lost midurethral slings and pelvic organ prolapse repair mesh, technologies and kits that have been among the most widely used and studied (Steve Blum, Senior Vice President and General Manager, Astora Women’s Health, and Kathie J. Lenzen, Senior Vice President and General Manager, Endo Device Operations, e-mail communication to physician customers, February 29, 2016). US Food and Drug Administration (FDA)−mandated 522 postmarket surveillance studies on these products have stopped enrolling patients, and we will therefore never glean the full science from fully enrolled and completed studies. This is a horrible precedent. How did this happen, and what do we need to do now to prevent further loss of helpful innovative technologies that benefit our patients with pelvic floor disorders?
Liability challenges precipitated shut downEndo Pharmaceuticals, the parent company of Astora (previously American Medical Systems Women’s Health division), last year offered $1.5 billion to settle a majority of its pending mesh litigation cases. I was told that the company wanted to put all of the negative noise from the relentless plaintiff attorney public media campaign behind it and refocus its attention on helping women with pelvic floor disorders.
Over the past year, 4 interested and capable buyers have been in discussions with the company to purchase and continue its product line. The company’s recent decision to not sell its product line and discontinue all operations was based on “the current legal environment and the ongoing challenges associated with vaginal mesh product liability” (Astora Women’s Health, e-mail communication to physician customers, February 29, 2016). If it had chosen to sell its product line, the company always would have remained a potential deep-pocketed codefendant in any future litigation against the company that purchased its products, technologies, and intellectual properties.
This is a frightening scenario that threatens existing companies that want to remain in the prolapse and incontinence product space. This is a threat to all future innovation for pelvic floor disorder therapies, and it discourages anyone or any company to invest in innovative products that may help our patients. In addition, it is a threat to our mission as physicians and surgeons to provide the very best therapies to our patients who deserve and expect us to do so.
Let me be crystal clear: Currently available midurethral slings are also in the crosshairs of plaintiff attorneys, and we are at risk of losing them as well if we do not act quickly, decisively, and as a unified force. More than 60% of the mesh lawsuits have been against midurethral slings, not the prolapse mesh kits focused on in the FDA Public Health notice of July 2011.1 In their class action lawsuits, plaintiff attorneys lumped together any procedure involving mesh in the pelvis to increase the number of their patient clients involved, which can drive up settlement awards, and they succeeded. In 2014, 128,030 sling procedures for incontinence were performed. Does anyone truly believe that the scientific literature supports that these patients would have been best served by 128,030 Burch procedures?
Some believe that Endo Pharmaceuticals’ placement of $1.5 billion in settlement funds was an error, “threw blood in the water,” and led to what has happened. Some believe that companies should fight every lawsuit to win and not settle. By the companies winning cases, the plaintiff attorneys lose their incentives to advertise and file more cases, as they only receive money if they win (or get a settlement) and are out of pocket for their costs and time if they lose.
Plaintiff attorneys have a responsibility to zealously advocate for their patient clients. Defense attorneys have a responsibility to zealously defend their corporate clients. We surgeons must realize that we have a responsibility to zealously advocate for our patients and do whatever is needed to best serve them and to protect the use (and development) of innovative products and therapies that give them value and a better quality of life.
Proactive steps surgeons can take
How do we do this? I suggest the following:
Implement expert oversight for litigation. Some of the large plaintiff awards were assisted by expert testimony based on a highly questionable scientific foundation. Judges give expert witnesses great latitude in their testimony, relying on the jury to discern the truth. I recommend that professional societies, such as the American College of Obstetricians and Gynecologists (ACOG), AmericanUrological Association (AUA), American Urogynecologic Society (AUGS), Society of Urodynamics, Female Pelvic Medicine & Urogenital Reconstruction (SUFU), and Society of Gynecologic Surgeons (SGS), establish a panel to review and carefully evaluate plaintiff expert testimony that has a questionable scientific foundation. If such a panel finds the scientific basis of testimony to be biased, untruthful, or unethical, the societies must publicly reprimand and sanction these experts. Only then would these experts no longer be used by the plaintiff attorneys.
Such an expert panel also could serve to educate the judges in federal and state courts on real science and not manufactured opinions.
We need juries that can understand the science so they truly can decide on cases involving complex technologies.
Support professional leadership efforts. I am encouraged that AUGS is working to establish guidelines for the management of mesh complications. I have seen cases in which a small amount of mesh exposure, best treated by limited local excision of the exposed mesh, instead has been treated by complete excision of every polypropylene fiber placed, resulting in an unnecessarily morbid surgery that leaves a scarred and small vagina. Notably, some of the surgeons who excise every polypropylene fiber are also working as plaintiff experts, who may then testify that the scarred, small vagina was caused by the mesh and the implanting surgeon.
Our professional society leadership and volunteer committees, especially from AUGS, have done a tremendous amount of work in assisting with the FDA-required 522 postmarket surveillance study research design; establishing a Pelvic Floor Disorders Registry (http://www.pfdr.org/) and a sling registry; and developing credentialing guidelines for sacrocolpopexy, transvaginal mesh, and slings. They deserve our gratitude and our participation in the registries. It would be a tragedy if all of this work does not lead to fully enrolled and completed 522 studies so that we can scientifically make decisions on products before any more treatment options are removed from the market.
Use video to scrutinize surgical outcomes data. The surgical literature shows extreme variance in outcomes and complications for vaginal mesh surgery, including exposure rates from 1% to 20% with the same mesh products. This only can be explained by depth of surgical dissection and implanting technique. Surgical outcomes have been shown to be related directly to surgical volumes and experience.2 I propose that going forward, any authors who publish their study outcomes and complication data on a surgical procedure must submit a surgical video that demonstrates exactly how the surgery was done.
Best serve the patient. We all need to rigorously follow our own surgery results, improve our techniques, and keep within our surgical skill sets. We need to share our outcome and complication data with our patients during the informed consent process, since we, and not the surgical literature, are performing their surgeries.
We need to be transparent and respectful of our colleagues with different skill sets, putting what is best for patients ahead of everything else. We must be mindful of our inherent biases toward surgeries we are personally very good at and comfortable with. We must respect that other surgeons may achieve better clinical outcomes than us with the same surgery. We need to teach each other the best reproducible surgical techniques to maximize outcomes and minimize complications.
We must humbly accept that not every surgeon can do every surgery (and should not try). If a patient would be best served with a surgery we are not skilled in, we must refer that patient to a colleague who is.
Encourage industry’s part in training. As new technologies are developed, we must be brutally honest with ourselves about whether or not we have the skill sets to use them. Industry must gauge the complexity of the surgical skill set necessary to use their products and limit attendance at their teaching labs to surgeons who have the skills required to obtain good outcomes and minimize complications.
We have reached the tipping pointWe have seen the enemy, and it is us. We now need to advocate zealously for our patients. We will succeed only if we keep what is best for our patients at the forefront of everything we do. We must today decide to lead or be led. If we do not lead, we will be led by others—to places that may not best serve our patients. Make no mistake, this is a tipping point. The future of midurethral slings and potential future innovations lie in our hands right now.
Notably, just days prior to Astora’s letter to its physician customers announcing the decision to discontinue all of its operations, the transobturator postanal sling system (TOPAS) for fecal incontinence, a product in the pipeline at Astora, received 3 unanimous 8-0 votes from an FDA device advisory panel on safety, efficacy, and benefit outweighing risk.3 The future of this technology is now uncertain as well.
I ask Endo Pharmaceuticals to reconsider abandoning all of its products and intellectual properties. I ask it to entertain discussions with large companies that want its technologies and intellectual properties and can indemnify it from future litigation. While there never is a guarantee of complete indemnification and the company does have a fiduciary responsibility to its shareholders, industry also has a responsibility to patients and surgeons to allow helpful technologies to persist.
According to Astora’s letter to its physician customers, “Patient health has always been our number one priority. As such, the business closure has been expedited so that you and your patients have the opportunity to assess alternative treatment options as soon as possible.”
That letter was dated February 29. I do not feel that 31 days’ notice is enough time for surgeons to assess—let alone learn and master—new treatment options. It would have been helpful if Endo Pharmaceuticals had given more notice and would at least have allowed other interested companies the option to purchase useful technologies and intellectual property to mitigate its rapid departure from the space. The company remains in the health care arena with its pharmaceutical products, and how it behaves leaving the surgical space will be noted and impact its brand and reputation.
Lessons from the morcellation situationHow quickly the power morcellator disappeared is a lesson to note very carefully, and it has important parallels to what we now face. I highly recommend that you read and study Lisa Rosenbaum’s article in New England Journal of Medicine, “N-of-1 policymaking—tragedy, trade-offs, and the demise of morcellation.”4 She eloquently discusses how decisions to terminate technologies based on passionate anecdotal stories and media campaigns, and not scientific study, does not serve the greater good. She explores lessons learned from the silicone breast implant saga as well, stating “the tendency to focus on eliminating an immediate harm while failing to consider potentially greater harms caused by that reaction is heightened by the power of tragic stories.”4
We need a calmer, less emotional, and balanced scientific approach to evaluate technologies. We need to consider what harm is done by not allowing new technologies to be adequately studied, improved, and implemented. Dr. Rosenbaum discusses what Cass Sunstein and Timur Kuran call the “availability cascade,” “a phenomenon whereby stories inform public perceptions and anyone challenging those perceptions is vilified.”4,5
No technology will ever be risk free, and there always will be some risks and complications that could be significant and chilling. However, patient autonomy requires a full discussion of a risk/benefit ratio that is based on science, and these scientific data must be allowed to be collected and learned. There even can be more significant and chilling complications from not using a technology as well.
It is challenging to speak science to emotion that is driven by tragic outcomes, but we can remain compassionate as we seek the science that will serve the greater good. Condemning proponents of carefully studied and properly implemented technologies as immoral is neither helpful nor constructive. Crushing the ability to thoroughly and scientifically study new technologies is not in the best interest of our patients with pelvic floor disorders.
It is time to reawaken the better angels of our natureWill we do the necessary work now no matter how uncomfortable it may make us feel? Or will we be intimidated and remain silent and disjointed? Will we participate in the registries and follow best clinical practice and credentialing guidelines? Will we hold ourselves and our colleagues accountable? It is time to remember why we became surgeons, and to start acting on our convictions.
To that end, we must ask ourselves, will we:
- honor the Hippocratic Oath that we took in medical school and “respect the hard-won scientific gains of those physicians in whose steps I walk, and gladly share such knowledge as is mine with those who are to follow”6
- “not be ashamed to say ‘I know not,’ nor will I fail to call in my colleagues when the skills of another are needed for a patient’s recovery”6
- zealously advocate for our patients to ensure we can offer them the very best therapies
- honor and respect the sacred trust patients place in us when we take them to the operating room
- lead or be led?
This is personal for me. My mother struggled with pelvic floor disorders. I always felt it grossly unfair that women who chose to give us life could suffer for the rest of theirs for that decision. These women deserve our very best. The 40 million women with pelvic floor disorders deserve—and expect—that we lead. Will we?
I am hopeful that we will. I believe we will rise to today’s challenges and protect and fight for our patients. I believe that years from now we will look back and be proud that we did the right thing, and in so doing protected and encouraged innovations that significantly enhanced the quality of our patients’ lives. I believe patients will recognize our genuine efforts and in so doing give our profession the respect and trust that I feel has been diminished.
I believe we will draw the needed courage and resolve from the oath we recited in medical school and remember that, “If I do not violate this oath, may I enjoy life and art, respected while I live and remembered with affection thereafter. May I always act so as to preserve the finest traditions of my calling and may I long experience the joy of healing those who seek my help.”6
I do believe we will.
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.
With the decision by Astora Women’s Health to discontinue operations as of March 31, 2016, we have lost midurethral slings and pelvic organ prolapse repair mesh, technologies and kits that have been among the most widely used and studied (Steve Blum, Senior Vice President and General Manager, Astora Women’s Health, and Kathie J. Lenzen, Senior Vice President and General Manager, Endo Device Operations, e-mail communication to physician customers, February 29, 2016). US Food and Drug Administration (FDA)−mandated 522 postmarket surveillance studies on these products have stopped enrolling patients, and we will therefore never glean the full science from fully enrolled and completed studies. This is a horrible precedent. How did this happen, and what do we need to do now to prevent further loss of helpful innovative technologies that benefit our patients with pelvic floor disorders?
Liability challenges precipitated shut downEndo Pharmaceuticals, the parent company of Astora (previously American Medical Systems Women’s Health division), last year offered $1.5 billion to settle a majority of its pending mesh litigation cases. I was told that the company wanted to put all of the negative noise from the relentless plaintiff attorney public media campaign behind it and refocus its attention on helping women with pelvic floor disorders.
Over the past year, 4 interested and capable buyers have been in discussions with the company to purchase and continue its product line. The company’s recent decision to not sell its product line and discontinue all operations was based on “the current legal environment and the ongoing challenges associated with vaginal mesh product liability” (Astora Women’s Health, e-mail communication to physician customers, February 29, 2016). If it had chosen to sell its product line, the company always would have remained a potential deep-pocketed codefendant in any future litigation against the company that purchased its products, technologies, and intellectual properties.
This is a frightening scenario that threatens existing companies that want to remain in the prolapse and incontinence product space. This is a threat to all future innovation for pelvic floor disorder therapies, and it discourages anyone or any company to invest in innovative products that may help our patients. In addition, it is a threat to our mission as physicians and surgeons to provide the very best therapies to our patients who deserve and expect us to do so.
Let me be crystal clear: Currently available midurethral slings are also in the crosshairs of plaintiff attorneys, and we are at risk of losing them as well if we do not act quickly, decisively, and as a unified force. More than 60% of the mesh lawsuits have been against midurethral slings, not the prolapse mesh kits focused on in the FDA Public Health notice of July 2011.1 In their class action lawsuits, plaintiff attorneys lumped together any procedure involving mesh in the pelvis to increase the number of their patient clients involved, which can drive up settlement awards, and they succeeded. In 2014, 128,030 sling procedures for incontinence were performed. Does anyone truly believe that the scientific literature supports that these patients would have been best served by 128,030 Burch procedures?
Some believe that Endo Pharmaceuticals’ placement of $1.5 billion in settlement funds was an error, “threw blood in the water,” and led to what has happened. Some believe that companies should fight every lawsuit to win and not settle. By the companies winning cases, the plaintiff attorneys lose their incentives to advertise and file more cases, as they only receive money if they win (or get a settlement) and are out of pocket for their costs and time if they lose.
Plaintiff attorneys have a responsibility to zealously advocate for their patient clients. Defense attorneys have a responsibility to zealously defend their corporate clients. We surgeons must realize that we have a responsibility to zealously advocate for our patients and do whatever is needed to best serve them and to protect the use (and development) of innovative products and therapies that give them value and a better quality of life.
Proactive steps surgeons can take
How do we do this? I suggest the following:
Implement expert oversight for litigation. Some of the large plaintiff awards were assisted by expert testimony based on a highly questionable scientific foundation. Judges give expert witnesses great latitude in their testimony, relying on the jury to discern the truth. I recommend that professional societies, such as the American College of Obstetricians and Gynecologists (ACOG), AmericanUrological Association (AUA), American Urogynecologic Society (AUGS), Society of Urodynamics, Female Pelvic Medicine & Urogenital Reconstruction (SUFU), and Society of Gynecologic Surgeons (SGS), establish a panel to review and carefully evaluate plaintiff expert testimony that has a questionable scientific foundation. If such a panel finds the scientific basis of testimony to be biased, untruthful, or unethical, the societies must publicly reprimand and sanction these experts. Only then would these experts no longer be used by the plaintiff attorneys.
Such an expert panel also could serve to educate the judges in federal and state courts on real science and not manufactured opinions.
We need juries that can understand the science so they truly can decide on cases involving complex technologies.
Support professional leadership efforts. I am encouraged that AUGS is working to establish guidelines for the management of mesh complications. I have seen cases in which a small amount of mesh exposure, best treated by limited local excision of the exposed mesh, instead has been treated by complete excision of every polypropylene fiber placed, resulting in an unnecessarily morbid surgery that leaves a scarred and small vagina. Notably, some of the surgeons who excise every polypropylene fiber are also working as plaintiff experts, who may then testify that the scarred, small vagina was caused by the mesh and the implanting surgeon.
Our professional society leadership and volunteer committees, especially from AUGS, have done a tremendous amount of work in assisting with the FDA-required 522 postmarket surveillance study research design; establishing a Pelvic Floor Disorders Registry (http://www.pfdr.org/) and a sling registry; and developing credentialing guidelines for sacrocolpopexy, transvaginal mesh, and slings. They deserve our gratitude and our participation in the registries. It would be a tragedy if all of this work does not lead to fully enrolled and completed 522 studies so that we can scientifically make decisions on products before any more treatment options are removed from the market.
Use video to scrutinize surgical outcomes data. The surgical literature shows extreme variance in outcomes and complications for vaginal mesh surgery, including exposure rates from 1% to 20% with the same mesh products. This only can be explained by depth of surgical dissection and implanting technique. Surgical outcomes have been shown to be related directly to surgical volumes and experience.2 I propose that going forward, any authors who publish their study outcomes and complication data on a surgical procedure must submit a surgical video that demonstrates exactly how the surgery was done.
Best serve the patient. We all need to rigorously follow our own surgery results, improve our techniques, and keep within our surgical skill sets. We need to share our outcome and complication data with our patients during the informed consent process, since we, and not the surgical literature, are performing their surgeries.
We need to be transparent and respectful of our colleagues with different skill sets, putting what is best for patients ahead of everything else. We must be mindful of our inherent biases toward surgeries we are personally very good at and comfortable with. We must respect that other surgeons may achieve better clinical outcomes than us with the same surgery. We need to teach each other the best reproducible surgical techniques to maximize outcomes and minimize complications.
We must humbly accept that not every surgeon can do every surgery (and should not try). If a patient would be best served with a surgery we are not skilled in, we must refer that patient to a colleague who is.
Encourage industry’s part in training. As new technologies are developed, we must be brutally honest with ourselves about whether or not we have the skill sets to use them. Industry must gauge the complexity of the surgical skill set necessary to use their products and limit attendance at their teaching labs to surgeons who have the skills required to obtain good outcomes and minimize complications.
We have reached the tipping pointWe have seen the enemy, and it is us. We now need to advocate zealously for our patients. We will succeed only if we keep what is best for our patients at the forefront of everything we do. We must today decide to lead or be led. If we do not lead, we will be led by others—to places that may not best serve our patients. Make no mistake, this is a tipping point. The future of midurethral slings and potential future innovations lie in our hands right now.
Notably, just days prior to Astora’s letter to its physician customers announcing the decision to discontinue all of its operations, the transobturator postanal sling system (TOPAS) for fecal incontinence, a product in the pipeline at Astora, received 3 unanimous 8-0 votes from an FDA device advisory panel on safety, efficacy, and benefit outweighing risk.3 The future of this technology is now uncertain as well.
I ask Endo Pharmaceuticals to reconsider abandoning all of its products and intellectual properties. I ask it to entertain discussions with large companies that want its technologies and intellectual properties and can indemnify it from future litigation. While there never is a guarantee of complete indemnification and the company does have a fiduciary responsibility to its shareholders, industry also has a responsibility to patients and surgeons to allow helpful technologies to persist.
According to Astora’s letter to its physician customers, “Patient health has always been our number one priority. As such, the business closure has been expedited so that you and your patients have the opportunity to assess alternative treatment options as soon as possible.”
That letter was dated February 29. I do not feel that 31 days’ notice is enough time for surgeons to assess—let alone learn and master—new treatment options. It would have been helpful if Endo Pharmaceuticals had given more notice and would at least have allowed other interested companies the option to purchase useful technologies and intellectual property to mitigate its rapid departure from the space. The company remains in the health care arena with its pharmaceutical products, and how it behaves leaving the surgical space will be noted and impact its brand and reputation.
Lessons from the morcellation situationHow quickly the power morcellator disappeared is a lesson to note very carefully, and it has important parallels to what we now face. I highly recommend that you read and study Lisa Rosenbaum’s article in New England Journal of Medicine, “N-of-1 policymaking—tragedy, trade-offs, and the demise of morcellation.”4 She eloquently discusses how decisions to terminate technologies based on passionate anecdotal stories and media campaigns, and not scientific study, does not serve the greater good. She explores lessons learned from the silicone breast implant saga as well, stating “the tendency to focus on eliminating an immediate harm while failing to consider potentially greater harms caused by that reaction is heightened by the power of tragic stories.”4
We need a calmer, less emotional, and balanced scientific approach to evaluate technologies. We need to consider what harm is done by not allowing new technologies to be adequately studied, improved, and implemented. Dr. Rosenbaum discusses what Cass Sunstein and Timur Kuran call the “availability cascade,” “a phenomenon whereby stories inform public perceptions and anyone challenging those perceptions is vilified.”4,5
No technology will ever be risk free, and there always will be some risks and complications that could be significant and chilling. However, patient autonomy requires a full discussion of a risk/benefit ratio that is based on science, and these scientific data must be allowed to be collected and learned. There even can be more significant and chilling complications from not using a technology as well.
It is challenging to speak science to emotion that is driven by tragic outcomes, but we can remain compassionate as we seek the science that will serve the greater good. Condemning proponents of carefully studied and properly implemented technologies as immoral is neither helpful nor constructive. Crushing the ability to thoroughly and scientifically study new technologies is not in the best interest of our patients with pelvic floor disorders.
It is time to reawaken the better angels of our natureWill we do the necessary work now no matter how uncomfortable it may make us feel? Or will we be intimidated and remain silent and disjointed? Will we participate in the registries and follow best clinical practice and credentialing guidelines? Will we hold ourselves and our colleagues accountable? It is time to remember why we became surgeons, and to start acting on our convictions.
To that end, we must ask ourselves, will we:
- honor the Hippocratic Oath that we took in medical school and “respect the hard-won scientific gains of those physicians in whose steps I walk, and gladly share such knowledge as is mine with those who are to follow”6
- “not be ashamed to say ‘I know not,’ nor will I fail to call in my colleagues when the skills of another are needed for a patient’s recovery”6
- zealously advocate for our patients to ensure we can offer them the very best therapies
- honor and respect the sacred trust patients place in us when we take them to the operating room
- lead or be led?
This is personal for me. My mother struggled with pelvic floor disorders. I always felt it grossly unfair that women who chose to give us life could suffer for the rest of theirs for that decision. These women deserve our very best. The 40 million women with pelvic floor disorders deserve—and expect—that we lead. Will we?
I am hopeful that we will. I believe we will rise to today’s challenges and protect and fight for our patients. I believe that years from now we will look back and be proud that we did the right thing, and in so doing protected and encouraged innovations that significantly enhanced the quality of our patients’ lives. I believe patients will recognize our genuine efforts and in so doing give our profession the respect and trust that I feel has been diminished.
I believe we will draw the needed courage and resolve from the oath we recited in medical school and remember that, “If I do not violate this oath, may I enjoy life and art, respected while I live and remembered with affection thereafter. May I always act so as to preserve the finest traditions of my calling and may I long experience the joy of healing those who seek my help.”6
I do believe we will.
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.
- Food and Drug Administration. Urogynecologic surgical mesh: update on the safety and effectiveness of transvaginal placement for pelvic organ prolapse. http://www.fda.gov/downloads/MedicalDevices/Safety/AlertsandNotices/UCM262760.pdf. Published July 2011. Accessed March 21, 2016.
- Meyer CP, Trinh QD. Complications after surgery for stress urinary incontinence: untangling a mesh of uncertainties. JAMA Surg. 2015;150(12):1175-1176.
- Food and Drug Administration Center for Devices and Radiological Health. Brief summary of the Gastroenterology and Urology Devices Panel of the Medical Devices Advisory Committee Meeting--February 25, 2016. http://www.fda.gov/downloads/AdvisoryCommittees/CommitteesMeetingMaterials/MedicalDevices/MedicalDevicesAdvisoryCommittee/Gastroenterology-UrologyDevicesPanel/UCM488397.pdf. Accessed March 21, 2016.
- Rosenbaum L. N-of-1--tragedy, trade-offs, and the demise of morcellation. N Engl J Med. 2016;374(10):986-990.
- Kuran T, Sunstein C. Availability cascades and risk regulation. Stanford Law Rev. 1999;51:683-768.
- Hippocratic oath, modern version. Adapted by Louis Lasagna. 1964. Johns Hopkins Sheridan Libraries and University Museums website. http://guides.library.jhu.edu/c.php?g=202502&p=1335759. Updated December 8, 2015. Accessed March 22, 2016.
- Food and Drug Administration. Urogynecologic surgical mesh: update on the safety and effectiveness of transvaginal placement for pelvic organ prolapse. http://www.fda.gov/downloads/MedicalDevices/Safety/AlertsandNotices/UCM262760.pdf. Published July 2011. Accessed March 21, 2016.
- Meyer CP, Trinh QD. Complications after surgery for stress urinary incontinence: untangling a mesh of uncertainties. JAMA Surg. 2015;150(12):1175-1176.
- Food and Drug Administration Center for Devices and Radiological Health. Brief summary of the Gastroenterology and Urology Devices Panel of the Medical Devices Advisory Committee Meeting--February 25, 2016. http://www.fda.gov/downloads/AdvisoryCommittees/CommitteesMeetingMaterials/MedicalDevices/MedicalDevicesAdvisoryCommittee/Gastroenterology-UrologyDevicesPanel/UCM488397.pdf. Accessed March 21, 2016.
- Rosenbaum L. N-of-1--tragedy, trade-offs, and the demise of morcellation. N Engl J Med. 2016;374(10):986-990.
- Kuran T, Sunstein C. Availability cascades and risk regulation. Stanford Law Rev. 1999;51:683-768.
- Hippocratic oath, modern version. Adapted by Louis Lasagna. 1964. Johns Hopkins Sheridan Libraries and University Museums website. http://guides.library.jhu.edu/c.php?g=202502&p=1335759. Updated December 8, 2015. Accessed March 22, 2016.
Janelle Yates: Author, editor, women’s health expert
As readers of OBG Management, you are very familiar with the name Janelle Yates. Janelle was an editor and writer for the journal for more than 15 years. Her byline has graced articles on, among other topics, obstetrics, liability, menopause, and tissue extraction. You may recall the 3-part series on endometriosis she authored beginning in April 2015.1 She worked with several expert surgeons to deliver an in-depth look at diagnosis, treatment, and related infertility. She interviewed presidents of the American Congress of Obstetricians and Gynecologists (ACOG)2 and worked with ACOG staff, including Lucia DiVenere, MA, on legislative articles for OBG Management, helping to bring new policies and practice changes to the forefront for readers.3,4
One topic that was of particular, personal interest to Janelle was breast cancer. She lived on and off with, but always under the shadow of, breast cancer for more than 8 years. This past December, Janelle developed a rare and incurable cancer of the nervous system, which took her life in January.
Janelle’s contributions to OBG Management Janelle worked closely with Robert L. Barbieri, MD, and the OBG Management Board of Editors on writing and editing projects. In fact, Janelle began as Senior Associate Editor with the journal in 2000, only a few months after Dr. Barbieri was inaugurated as Editor in Chief.
“Janelle was exceptionally skillful in polishing a rough manuscript into a superbly crafted article,” says Dr. Barbieri. “The physician authors with whom she collaborated were in awe of her talent and recognized the value of her contributions to advancing women’s health care.”
“Janelle approached the craft of writing like an artist, always searching for an additional layer of deeper meaning and insight. Her strength of character and myriad life experiences gave her unique skills in exploring, questioning, and improving the content that was brought forth.”
“She and I had an ongoing conversation on the pros and cons of being concise,” says Dr. Barbieri. “I would ask her the hypothetical, ‘If an author could effectively deliver his or her core message in a 1-page article, why take 3 pages to do so?’ As a counterpoint, her perspective was that if you could concisely make your point in 3 pages, it might be even better for an author to expand their article to 9 pages to help the reader achieve a deeper level of understanding and insight.”
In May 2013, Barbara S. Levy, MD, after serving for 17 years as an OBG Management Board of Editors member, assumed the position of Vice President for Health Policy at ACOG, and resigned her position on the journal’s editorial board. Janelle collaborated with Dr. Levy on an article commemorating her lifetime of service to women.5 Dr. Levy recalls that article, and the numerous others she partnered on with Janelle:
“She was the quintessential professional. We are professional doctors, but Janelle was a professional writer and editor. She had an ability to, when speaking with us, get the best out of us, and take what we said and translate that into a cogent, crisp presentation that was really meaningful to readers. Having her perspective as a partner in writing helped me reach a core in readers that I believe I otherwise would not have been able to reach.”
Andrew M. Kaunitz, MD, Board of Editors member since 2006, describes Janelle as “a wonderful colleague and person.”
“My early perceptions of Janelle,” he says, “relate to her tremendous skills as a medical writer. Over time, however, I recognized that, in addition to her wonderful talents as a writer, she brought what I can only call a sense of grace to each interaction that I had with her. I continue to find it hard to imagine a world without her.”
“During my 15-year excursion as the Editor in Chief of OBG Management,” says Dr. Barbieri, “Janelle was the perfect guide and travel companion. She will always be in my thoughts and heart.”
Janelle’s memory enduresJanelle’s colleagues at the journal office and the Board of Editors honor her dedication to OBG Management, and truly to women’s health in general, in a permanent way in the pages of OBG Management. Janelle’s name has been added to the journal’s staff masthead with the title, “Editor Emeritus.” We feel this is a small but sincere gesture from those of us who have had the immense pleasure and incredible honor to work with Janelle over the years.
John Baranowski, who served as Editor of OBG Management from 2008 until mid-2012, eloquently states: “As her supervisor for several years, I was the initial recipient of tens of thousands of her well-ordered, well-chosen, and insightful words. At this time, it is hard for me to find words to offer on her behalf. Her outsized skill, her easeful manner, and her certain success at improving the care that physicians provide—those are humbling, silencing remembrances; things of such great value that words just do not work as tribute.”
Dianne Reynolds, Publisher of OBG Management, has known Janelle since 2008 and says that she feels blessed and fortunate to have had Janelle in her life on more than just a professional level. “I will cherish her memory forever,” she says.
OBG Management Managing Editor Deborah Reale joined the journal staff in 2010. “Words connected Janelle and I not only in our editorial work but also personally, through our shared love of poetry,” she says. Unbeknownst to many, Janelle was a published poet. She also wrote two biographies, of Woodie Guthrie and Zora Neale Hurston, while working many years ago as an editor for Ward Hill Press.
Like so many others, I feel privileged to have worked with Janelle. Her work was fearless. Whether it was an audio interview with gynecologic oncologist Eva Chalas, MD, on preserving minimally invasive approaches to gynecologic surgery6 or a Q&A article on liability claims in obstetrics,7 Janelle did it brilliantly. She applied her years of knowledge and experience to each piece she wrote or edited, always bringing an expert’s best voice forward. In fact, Dianne Reynolds says, “Janelle once told me that she had dreamed of being a doctor, and she imagined herself pushing through hospital doors on her way to treat patients. Instead, Janelle used her acquired medical knowledge in women’s health and writing acumen to assist physicians in explaining their techniques for the benefit of their colleagues.”
Janelle’s siblings Diana and Kent Yates, and her daughter Adrienne Cano, say they have been aware of how supportive the OBG Management extended team has been to Janelle. In speaking with Board of Editors member, Cheryl B. Iglesia, MD, Diana says, “This was such a blessing in her life. It was a rare thing, the kind of relationship she had with all of you. We appreciate so very much your nurturing of her talents and of her as a person.”
Janelle meant a great deal to her colleagues, of course because of her superb work and wise perspective, but also because of her warmth and gentle ease. Simply put, Janelle was a wonderful person to be near.
“She was absolutely amazing and will be greatly missed both personally and professionally,” says 10-year OBG Management board member JoAnn V. Pinkerton, MD.
Dr. Iglesia asserts, “Janelle never will be forgotten. She truly has left a legacy of very important articles for many generations.”
Janelle, we can only hope that with your name on the masthead, readers of OBG Management in future generations will have the privilege of your touch. May that touch bring them the gift of journalistic accuracy, professional integrity, spot-on syntax and, above all, compelling reading.
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.
- Yates J. Endometriosis: expert answers to 7 crucial questions on diagnosis. OBG Manag. 2015;27(4):39–40, 42–46.
- Yates J. ACOG presidents highlight their visions for the College at the 2015 clinical meeting. OBG Manag. 2015;27(5).
- Yates J, DiVenere L. It's a Republican majority following midterm election results. How will that affect the ACA and women's health? OBG Manag. 2014(26):12.
- DiVenere L. The well-woman visit comes of age: what it offers, how we got here. OBG Manag. 2016;28(1):25–29.
- Yates J. A lifetime of service to women and their health--the career of Barbara S. Levy, MD. OBG Manag. 2015;25(5):17–20.
- Yates J. 46 experts pen open letter to the FDA on uterine power morcellation. An interview with Eva Chalas, MD. OBG Manag. 2015;12.
- Yates J. A survey of liability claims against obstetric providers highlights major areas of contention. OBG Manag. 2015; 27(8):40–42.
As readers of OBG Management, you are very familiar with the name Janelle Yates. Janelle was an editor and writer for the journal for more than 15 years. Her byline has graced articles on, among other topics, obstetrics, liability, menopause, and tissue extraction. You may recall the 3-part series on endometriosis she authored beginning in April 2015.1 She worked with several expert surgeons to deliver an in-depth look at diagnosis, treatment, and related infertility. She interviewed presidents of the American Congress of Obstetricians and Gynecologists (ACOG)2 and worked with ACOG staff, including Lucia DiVenere, MA, on legislative articles for OBG Management, helping to bring new policies and practice changes to the forefront for readers.3,4
One topic that was of particular, personal interest to Janelle was breast cancer. She lived on and off with, but always under the shadow of, breast cancer for more than 8 years. This past December, Janelle developed a rare and incurable cancer of the nervous system, which took her life in January.
Janelle’s contributions to OBG Management Janelle worked closely with Robert L. Barbieri, MD, and the OBG Management Board of Editors on writing and editing projects. In fact, Janelle began as Senior Associate Editor with the journal in 2000, only a few months after Dr. Barbieri was inaugurated as Editor in Chief.
“Janelle was exceptionally skillful in polishing a rough manuscript into a superbly crafted article,” says Dr. Barbieri. “The physician authors with whom she collaborated were in awe of her talent and recognized the value of her contributions to advancing women’s health care.”
“Janelle approached the craft of writing like an artist, always searching for an additional layer of deeper meaning and insight. Her strength of character and myriad life experiences gave her unique skills in exploring, questioning, and improving the content that was brought forth.”
“She and I had an ongoing conversation on the pros and cons of being concise,” says Dr. Barbieri. “I would ask her the hypothetical, ‘If an author could effectively deliver his or her core message in a 1-page article, why take 3 pages to do so?’ As a counterpoint, her perspective was that if you could concisely make your point in 3 pages, it might be even better for an author to expand their article to 9 pages to help the reader achieve a deeper level of understanding and insight.”
In May 2013, Barbara S. Levy, MD, after serving for 17 years as an OBG Management Board of Editors member, assumed the position of Vice President for Health Policy at ACOG, and resigned her position on the journal’s editorial board. Janelle collaborated with Dr. Levy on an article commemorating her lifetime of service to women.5 Dr. Levy recalls that article, and the numerous others she partnered on with Janelle:
“She was the quintessential professional. We are professional doctors, but Janelle was a professional writer and editor. She had an ability to, when speaking with us, get the best out of us, and take what we said and translate that into a cogent, crisp presentation that was really meaningful to readers. Having her perspective as a partner in writing helped me reach a core in readers that I believe I otherwise would not have been able to reach.”
Andrew M. Kaunitz, MD, Board of Editors member since 2006, describes Janelle as “a wonderful colleague and person.”
“My early perceptions of Janelle,” he says, “relate to her tremendous skills as a medical writer. Over time, however, I recognized that, in addition to her wonderful talents as a writer, she brought what I can only call a sense of grace to each interaction that I had with her. I continue to find it hard to imagine a world without her.”
“During my 15-year excursion as the Editor in Chief of OBG Management,” says Dr. Barbieri, “Janelle was the perfect guide and travel companion. She will always be in my thoughts and heart.”
Janelle’s memory enduresJanelle’s colleagues at the journal office and the Board of Editors honor her dedication to OBG Management, and truly to women’s health in general, in a permanent way in the pages of OBG Management. Janelle’s name has been added to the journal’s staff masthead with the title, “Editor Emeritus.” We feel this is a small but sincere gesture from those of us who have had the immense pleasure and incredible honor to work with Janelle over the years.
John Baranowski, who served as Editor of OBG Management from 2008 until mid-2012, eloquently states: “As her supervisor for several years, I was the initial recipient of tens of thousands of her well-ordered, well-chosen, and insightful words. At this time, it is hard for me to find words to offer on her behalf. Her outsized skill, her easeful manner, and her certain success at improving the care that physicians provide—those are humbling, silencing remembrances; things of such great value that words just do not work as tribute.”
Dianne Reynolds, Publisher of OBG Management, has known Janelle since 2008 and says that she feels blessed and fortunate to have had Janelle in her life on more than just a professional level. “I will cherish her memory forever,” she says.
OBG Management Managing Editor Deborah Reale joined the journal staff in 2010. “Words connected Janelle and I not only in our editorial work but also personally, through our shared love of poetry,” she says. Unbeknownst to many, Janelle was a published poet. She also wrote two biographies, of Woodie Guthrie and Zora Neale Hurston, while working many years ago as an editor for Ward Hill Press.
Like so many others, I feel privileged to have worked with Janelle. Her work was fearless. Whether it was an audio interview with gynecologic oncologist Eva Chalas, MD, on preserving minimally invasive approaches to gynecologic surgery6 or a Q&A article on liability claims in obstetrics,7 Janelle did it brilliantly. She applied her years of knowledge and experience to each piece she wrote or edited, always bringing an expert’s best voice forward. In fact, Dianne Reynolds says, “Janelle once told me that she had dreamed of being a doctor, and she imagined herself pushing through hospital doors on her way to treat patients. Instead, Janelle used her acquired medical knowledge in women’s health and writing acumen to assist physicians in explaining their techniques for the benefit of their colleagues.”
Janelle’s siblings Diana and Kent Yates, and her daughter Adrienne Cano, say they have been aware of how supportive the OBG Management extended team has been to Janelle. In speaking with Board of Editors member, Cheryl B. Iglesia, MD, Diana says, “This was such a blessing in her life. It was a rare thing, the kind of relationship she had with all of you. We appreciate so very much your nurturing of her talents and of her as a person.”
Janelle meant a great deal to her colleagues, of course because of her superb work and wise perspective, but also because of her warmth and gentle ease. Simply put, Janelle was a wonderful person to be near.
“She was absolutely amazing and will be greatly missed both personally and professionally,” says 10-year OBG Management board member JoAnn V. Pinkerton, MD.
Dr. Iglesia asserts, “Janelle never will be forgotten. She truly has left a legacy of very important articles for many generations.”
Janelle, we can only hope that with your name on the masthead, readers of OBG Management in future generations will have the privilege of your touch. May that touch bring them the gift of journalistic accuracy, professional integrity, spot-on syntax and, above all, compelling reading.
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.
As readers of OBG Management, you are very familiar with the name Janelle Yates. Janelle was an editor and writer for the journal for more than 15 years. Her byline has graced articles on, among other topics, obstetrics, liability, menopause, and tissue extraction. You may recall the 3-part series on endometriosis she authored beginning in April 2015.1 She worked with several expert surgeons to deliver an in-depth look at diagnosis, treatment, and related infertility. She interviewed presidents of the American Congress of Obstetricians and Gynecologists (ACOG)2 and worked with ACOG staff, including Lucia DiVenere, MA, on legislative articles for OBG Management, helping to bring new policies and practice changes to the forefront for readers.3,4
One topic that was of particular, personal interest to Janelle was breast cancer. She lived on and off with, but always under the shadow of, breast cancer for more than 8 years. This past December, Janelle developed a rare and incurable cancer of the nervous system, which took her life in January.
Janelle’s contributions to OBG Management Janelle worked closely with Robert L. Barbieri, MD, and the OBG Management Board of Editors on writing and editing projects. In fact, Janelle began as Senior Associate Editor with the journal in 2000, only a few months after Dr. Barbieri was inaugurated as Editor in Chief.
“Janelle was exceptionally skillful in polishing a rough manuscript into a superbly crafted article,” says Dr. Barbieri. “The physician authors with whom she collaborated were in awe of her talent and recognized the value of her contributions to advancing women’s health care.”
“Janelle approached the craft of writing like an artist, always searching for an additional layer of deeper meaning and insight. Her strength of character and myriad life experiences gave her unique skills in exploring, questioning, and improving the content that was brought forth.”
“She and I had an ongoing conversation on the pros and cons of being concise,” says Dr. Barbieri. “I would ask her the hypothetical, ‘If an author could effectively deliver his or her core message in a 1-page article, why take 3 pages to do so?’ As a counterpoint, her perspective was that if you could concisely make your point in 3 pages, it might be even better for an author to expand their article to 9 pages to help the reader achieve a deeper level of understanding and insight.”
In May 2013, Barbara S. Levy, MD, after serving for 17 years as an OBG Management Board of Editors member, assumed the position of Vice President for Health Policy at ACOG, and resigned her position on the journal’s editorial board. Janelle collaborated with Dr. Levy on an article commemorating her lifetime of service to women.5 Dr. Levy recalls that article, and the numerous others she partnered on with Janelle:
“She was the quintessential professional. We are professional doctors, but Janelle was a professional writer and editor. She had an ability to, when speaking with us, get the best out of us, and take what we said and translate that into a cogent, crisp presentation that was really meaningful to readers. Having her perspective as a partner in writing helped me reach a core in readers that I believe I otherwise would not have been able to reach.”
Andrew M. Kaunitz, MD, Board of Editors member since 2006, describes Janelle as “a wonderful colleague and person.”
“My early perceptions of Janelle,” he says, “relate to her tremendous skills as a medical writer. Over time, however, I recognized that, in addition to her wonderful talents as a writer, she brought what I can only call a sense of grace to each interaction that I had with her. I continue to find it hard to imagine a world without her.”
“During my 15-year excursion as the Editor in Chief of OBG Management,” says Dr. Barbieri, “Janelle was the perfect guide and travel companion. She will always be in my thoughts and heart.”
Janelle’s memory enduresJanelle’s colleagues at the journal office and the Board of Editors honor her dedication to OBG Management, and truly to women’s health in general, in a permanent way in the pages of OBG Management. Janelle’s name has been added to the journal’s staff masthead with the title, “Editor Emeritus.” We feel this is a small but sincere gesture from those of us who have had the immense pleasure and incredible honor to work with Janelle over the years.
John Baranowski, who served as Editor of OBG Management from 2008 until mid-2012, eloquently states: “As her supervisor for several years, I was the initial recipient of tens of thousands of her well-ordered, well-chosen, and insightful words. At this time, it is hard for me to find words to offer on her behalf. Her outsized skill, her easeful manner, and her certain success at improving the care that physicians provide—those are humbling, silencing remembrances; things of such great value that words just do not work as tribute.”
Dianne Reynolds, Publisher of OBG Management, has known Janelle since 2008 and says that she feels blessed and fortunate to have had Janelle in her life on more than just a professional level. “I will cherish her memory forever,” she says.
OBG Management Managing Editor Deborah Reale joined the journal staff in 2010. “Words connected Janelle and I not only in our editorial work but also personally, through our shared love of poetry,” she says. Unbeknownst to many, Janelle was a published poet. She also wrote two biographies, of Woodie Guthrie and Zora Neale Hurston, while working many years ago as an editor for Ward Hill Press.
Like so many others, I feel privileged to have worked with Janelle. Her work was fearless. Whether it was an audio interview with gynecologic oncologist Eva Chalas, MD, on preserving minimally invasive approaches to gynecologic surgery6 or a Q&A article on liability claims in obstetrics,7 Janelle did it brilliantly. She applied her years of knowledge and experience to each piece she wrote or edited, always bringing an expert’s best voice forward. In fact, Dianne Reynolds says, “Janelle once told me that she had dreamed of being a doctor, and she imagined herself pushing through hospital doors on her way to treat patients. Instead, Janelle used her acquired medical knowledge in women’s health and writing acumen to assist physicians in explaining their techniques for the benefit of their colleagues.”
Janelle’s siblings Diana and Kent Yates, and her daughter Adrienne Cano, say they have been aware of how supportive the OBG Management extended team has been to Janelle. In speaking with Board of Editors member, Cheryl B. Iglesia, MD, Diana says, “This was such a blessing in her life. It was a rare thing, the kind of relationship she had with all of you. We appreciate so very much your nurturing of her talents and of her as a person.”
Janelle meant a great deal to her colleagues, of course because of her superb work and wise perspective, but also because of her warmth and gentle ease. Simply put, Janelle was a wonderful person to be near.
“She was absolutely amazing and will be greatly missed both personally and professionally,” says 10-year OBG Management board member JoAnn V. Pinkerton, MD.
Dr. Iglesia asserts, “Janelle never will be forgotten. She truly has left a legacy of very important articles for many generations.”
Janelle, we can only hope that with your name on the masthead, readers of OBG Management in future generations will have the privilege of your touch. May that touch bring them the gift of journalistic accuracy, professional integrity, spot-on syntax and, above all, compelling reading.
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.
- Yates J. Endometriosis: expert answers to 7 crucial questions on diagnosis. OBG Manag. 2015;27(4):39–40, 42–46.
- Yates J. ACOG presidents highlight their visions for the College at the 2015 clinical meeting. OBG Manag. 2015;27(5).
- Yates J, DiVenere L. It's a Republican majority following midterm election results. How will that affect the ACA and women's health? OBG Manag. 2014(26):12.
- DiVenere L. The well-woman visit comes of age: what it offers, how we got here. OBG Manag. 2016;28(1):25–29.
- Yates J. A lifetime of service to women and their health--the career of Barbara S. Levy, MD. OBG Manag. 2015;25(5):17–20.
- Yates J. 46 experts pen open letter to the FDA on uterine power morcellation. An interview with Eva Chalas, MD. OBG Manag. 2015;12.
- Yates J. A survey of liability claims against obstetric providers highlights major areas of contention. OBG Manag. 2015; 27(8):40–42.
- Yates J. Endometriosis: expert answers to 7 crucial questions on diagnosis. OBG Manag. 2015;27(4):39–40, 42–46.
- Yates J. ACOG presidents highlight their visions for the College at the 2015 clinical meeting. OBG Manag. 2015;27(5).
- Yates J, DiVenere L. It's a Republican majority following midterm election results. How will that affect the ACA and women's health? OBG Manag. 2014(26):12.
- DiVenere L. The well-woman visit comes of age: what it offers, how we got here. OBG Manag. 2016;28(1):25–29.
- Yates J. A lifetime of service to women and their health--the career of Barbara S. Levy, MD. OBG Manag. 2015;25(5):17–20.
- Yates J. 46 experts pen open letter to the FDA on uterine power morcellation. An interview with Eva Chalas, MD. OBG Manag. 2015;12.
- Yates J. A survey of liability claims against obstetric providers highlights major areas of contention. OBG Manag. 2015; 27(8):40–42.
Reader reactions to the problem of inadequate contraception for high-risk women
“Contraception as a vital sign”
In his recent Editorial Dr. Barbieri asked for ideas to improve contraception counseling for women with medical problems that put them at risk for adverse pregnancy outcomes. His idea of “contraception status as a vital sign” is applied in our very large group practice in Northern California using the electronic health record (EHR).
Over 10 years ago, I attempted to put a hard stop in the EHR to require documentation that women of reproductive age be evaluated for contraception. This scheme seemed to be too cumbersome and was rejected at the time.
The idea was not abandoned, however. Medical assistants must now document a means of contraception for each woman of reproductive age. This does not guarantee that a physician will look at the information, but it is a step in the right direction.
My hope is that someday we will have automatic contraception as a vital sign documentation for all reproductive-age women, including “children” who are documented as menstruating. In the meantime, thank you for highlighting this critical issue.
Tia Will, MD
Sacramento, California
Reduce reimbursement when standard of care is not met
When I read Dr. Barbieri’s Editorial, I was surprised that he avoided the elephant in the room: the current political climate of denying contraception to women, including the defunding of Planned Parenthood and the Supreme Court decision to allow corporations to deny contraceptive coverage for religious issues.
Although I am not currently involved in women’s health, I do work under the auspices of a large Catholic health care system in the United States. Here, all employees are prohibited from providing contraceptive procedures, prescriptions, or even counseling unless it is a Natural Family Planning/ Fertility Awareness Method. These employees also are not provided individual contraceptive health coverage by their employer; this coverage is provided by the federal government thanks to the Affordable Care Act.
Contraception is part of the standard of care for women. However, many women are denied this standard of care due to “religious” reasons, which I suspect may be partially financial and/or political in nature.
This issue must therefore be addressed by political and financial means. My recommendation is for legislation that mandates lower reimbursement rates for health care systems and providers that refuse to offer full contraceptive options to women. If they do not provide full care, they do not get full payment for services. The money saved by reduced reimbursements could then fund federal women’s health clinics in areas dominated by “religious” health care systems that would guarantee full reproductive health options to all.
Name and practice location withheld
Remove Medicaid barriers to postpartum sterilization
An issue not addressed in Dr. Barbieri’s Editorial is that of women who, after appropriate and extensive counseling by a physician and with a full understanding of the reproductive implications and the possible adverse effect of additional pregnancies on their health and life, decide for permanent contraception. A woman’s opportunity to obtain postpartum or interval contraceptive procedure varies by her insurance coverage, which is indirectly associated with her ethnicity or race.
In 1979, Medicaid Title XIX imposed a 30-day interval between the signing of the sterilization informed consent by the patient and the performance of the procedure. These regulations are still in effect today. What was instituted to protect vulnerable populations from coerced methods in the 1970s represents an anachronistic and archaic approach in the 21st Century. This regulation discriminates against low-income and minority women whose health care is covered by public insurance yet who are frequently at highest risk for unintended and possible risky pregnancy or abortion. In simple words, this imposition violates the standards of justice, beneficence, and nonmaleficence as it treats publicly insured women differently from privately insured women.
The American Medical Association and the American College of Obstetricians and Gynecologists1 state that this regulation must be revised and charged practitioners to develop policies and procedures to ensure all women who desire postpartum sterilization can receive it. It is incumbent upon all women’s health care physicians to see that this barrier is removed.
Federico G. Mariona, MD, MHSA
Dearborn, Michigan
Reference
- American College of Obstetricians and Gynecologists Committee on Health Care for Underserved Women. ACOG Committee Opinion No. 530: access to postpartum sterilization. Obstet Gynecol. 2012;120(1):212–215.
Educate the sexual partners of at-risk women
It always strikes me how little emphasis is placed on including the sexual partners of women with serious medical problems in the dialogue about responsibility for at-risk pregnancy. As advocates for women’s health, we should educate the couple about vasectomy and liberally provide referrals. Community outreach to help men understand how they can protect their partner from potentially dangerous unwanted pregnancy is extremely important and not stressed enough. Vasectomy is a quick, safe procedure performed in a physician’s office under local anesthesia. Why should any woman who has already risked her life carrying and delivering a baby be required to bear the contraceptive burden when there is a safe and convenient alternative?
Emily Gubert, MD
East Islip, New York
Dr. Barbieri responds
I thank Drs. Will, Mariona, and Gubert and the anonymous author for their wonderful recommendations on approaches to help improve contraceptive care for women. I agree with Dr. Will that the EHR is a valuable tool to advance contraceptive care. The anonymous author and Dr. Mariona make the critically important point that all women should have access to desired contraception without any barriers based on institutional beliefs or government regulations. The patient’s needs should be prioritized in all medical decision making. I agree with Dr. Gubert that including the male partner in the care process is an important part of effective contraception for women. I enthusiastically agree with her that the best permanent contraceptive for a stable couple is vasectomy.
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.
“Contraception as a vital sign”
In his recent Editorial Dr. Barbieri asked for ideas to improve contraception counseling for women with medical problems that put them at risk for adverse pregnancy outcomes. His idea of “contraception status as a vital sign” is applied in our very large group practice in Northern California using the electronic health record (EHR).
Over 10 years ago, I attempted to put a hard stop in the EHR to require documentation that women of reproductive age be evaluated for contraception. This scheme seemed to be too cumbersome and was rejected at the time.
The idea was not abandoned, however. Medical assistants must now document a means of contraception for each woman of reproductive age. This does not guarantee that a physician will look at the information, but it is a step in the right direction.
My hope is that someday we will have automatic contraception as a vital sign documentation for all reproductive-age women, including “children” who are documented as menstruating. In the meantime, thank you for highlighting this critical issue.
Tia Will, MD
Sacramento, California
Reduce reimbursement when standard of care is not met
When I read Dr. Barbieri’s Editorial, I was surprised that he avoided the elephant in the room: the current political climate of denying contraception to women, including the defunding of Planned Parenthood and the Supreme Court decision to allow corporations to deny contraceptive coverage for religious issues.
Although I am not currently involved in women’s health, I do work under the auspices of a large Catholic health care system in the United States. Here, all employees are prohibited from providing contraceptive procedures, prescriptions, or even counseling unless it is a Natural Family Planning/ Fertility Awareness Method. These employees also are not provided individual contraceptive health coverage by their employer; this coverage is provided by the federal government thanks to the Affordable Care Act.
Contraception is part of the standard of care for women. However, many women are denied this standard of care due to “religious” reasons, which I suspect may be partially financial and/or political in nature.
This issue must therefore be addressed by political and financial means. My recommendation is for legislation that mandates lower reimbursement rates for health care systems and providers that refuse to offer full contraceptive options to women. If they do not provide full care, they do not get full payment for services. The money saved by reduced reimbursements could then fund federal women’s health clinics in areas dominated by “religious” health care systems that would guarantee full reproductive health options to all.
Name and practice location withheld
Remove Medicaid barriers to postpartum sterilization
An issue not addressed in Dr. Barbieri’s Editorial is that of women who, after appropriate and extensive counseling by a physician and with a full understanding of the reproductive implications and the possible adverse effect of additional pregnancies on their health and life, decide for permanent contraception. A woman’s opportunity to obtain postpartum or interval contraceptive procedure varies by her insurance coverage, which is indirectly associated with her ethnicity or race.
In 1979, Medicaid Title XIX imposed a 30-day interval between the signing of the sterilization informed consent by the patient and the performance of the procedure. These regulations are still in effect today. What was instituted to protect vulnerable populations from coerced methods in the 1970s represents an anachronistic and archaic approach in the 21st Century. This regulation discriminates against low-income and minority women whose health care is covered by public insurance yet who are frequently at highest risk for unintended and possible risky pregnancy or abortion. In simple words, this imposition violates the standards of justice, beneficence, and nonmaleficence as it treats publicly insured women differently from privately insured women.
The American Medical Association and the American College of Obstetricians and Gynecologists1 state that this regulation must be revised and charged practitioners to develop policies and procedures to ensure all women who desire postpartum sterilization can receive it. It is incumbent upon all women’s health care physicians to see that this barrier is removed.
Federico G. Mariona, MD, MHSA
Dearborn, Michigan
Reference
- American College of Obstetricians and Gynecologists Committee on Health Care for Underserved Women. ACOG Committee Opinion No. 530: access to postpartum sterilization. Obstet Gynecol. 2012;120(1):212–215.
Educate the sexual partners of at-risk women
It always strikes me how little emphasis is placed on including the sexual partners of women with serious medical problems in the dialogue about responsibility for at-risk pregnancy. As advocates for women’s health, we should educate the couple about vasectomy and liberally provide referrals. Community outreach to help men understand how they can protect their partner from potentially dangerous unwanted pregnancy is extremely important and not stressed enough. Vasectomy is a quick, safe procedure performed in a physician’s office under local anesthesia. Why should any woman who has already risked her life carrying and delivering a baby be required to bear the contraceptive burden when there is a safe and convenient alternative?
Emily Gubert, MD
East Islip, New York
Dr. Barbieri responds
I thank Drs. Will, Mariona, and Gubert and the anonymous author for their wonderful recommendations on approaches to help improve contraceptive care for women. I agree with Dr. Will that the EHR is a valuable tool to advance contraceptive care. The anonymous author and Dr. Mariona make the critically important point that all women should have access to desired contraception without any barriers based on institutional beliefs or government regulations. The patient’s needs should be prioritized in all medical decision making. I agree with Dr. Gubert that including the male partner in the care process is an important part of effective contraception for women. I enthusiastically agree with her that the best permanent contraceptive for a stable couple is vasectomy.
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.
“Contraception as a vital sign”
In his recent Editorial Dr. Barbieri asked for ideas to improve contraception counseling for women with medical problems that put them at risk for adverse pregnancy outcomes. His idea of “contraception status as a vital sign” is applied in our very large group practice in Northern California using the electronic health record (EHR).
Over 10 years ago, I attempted to put a hard stop in the EHR to require documentation that women of reproductive age be evaluated for contraception. This scheme seemed to be too cumbersome and was rejected at the time.
The idea was not abandoned, however. Medical assistants must now document a means of contraception for each woman of reproductive age. This does not guarantee that a physician will look at the information, but it is a step in the right direction.
My hope is that someday we will have automatic contraception as a vital sign documentation for all reproductive-age women, including “children” who are documented as menstruating. In the meantime, thank you for highlighting this critical issue.
Tia Will, MD
Sacramento, California
Reduce reimbursement when standard of care is not met
When I read Dr. Barbieri’s Editorial, I was surprised that he avoided the elephant in the room: the current political climate of denying contraception to women, including the defunding of Planned Parenthood and the Supreme Court decision to allow corporations to deny contraceptive coverage for religious issues.
Although I am not currently involved in women’s health, I do work under the auspices of a large Catholic health care system in the United States. Here, all employees are prohibited from providing contraceptive procedures, prescriptions, or even counseling unless it is a Natural Family Planning/ Fertility Awareness Method. These employees also are not provided individual contraceptive health coverage by their employer; this coverage is provided by the federal government thanks to the Affordable Care Act.
Contraception is part of the standard of care for women. However, many women are denied this standard of care due to “religious” reasons, which I suspect may be partially financial and/or political in nature.
This issue must therefore be addressed by political and financial means. My recommendation is for legislation that mandates lower reimbursement rates for health care systems and providers that refuse to offer full contraceptive options to women. If they do not provide full care, they do not get full payment for services. The money saved by reduced reimbursements could then fund federal women’s health clinics in areas dominated by “religious” health care systems that would guarantee full reproductive health options to all.
Name and practice location withheld
Remove Medicaid barriers to postpartum sterilization
An issue not addressed in Dr. Barbieri’s Editorial is that of women who, after appropriate and extensive counseling by a physician and with a full understanding of the reproductive implications and the possible adverse effect of additional pregnancies on their health and life, decide for permanent contraception. A woman’s opportunity to obtain postpartum or interval contraceptive procedure varies by her insurance coverage, which is indirectly associated with her ethnicity or race.
In 1979, Medicaid Title XIX imposed a 30-day interval between the signing of the sterilization informed consent by the patient and the performance of the procedure. These regulations are still in effect today. What was instituted to protect vulnerable populations from coerced methods in the 1970s represents an anachronistic and archaic approach in the 21st Century. This regulation discriminates against low-income and minority women whose health care is covered by public insurance yet who are frequently at highest risk for unintended and possible risky pregnancy or abortion. In simple words, this imposition violates the standards of justice, beneficence, and nonmaleficence as it treats publicly insured women differently from privately insured women.
The American Medical Association and the American College of Obstetricians and Gynecologists1 state that this regulation must be revised and charged practitioners to develop policies and procedures to ensure all women who desire postpartum sterilization can receive it. It is incumbent upon all women’s health care physicians to see that this barrier is removed.
Federico G. Mariona, MD, MHSA
Dearborn, Michigan
Reference
- American College of Obstetricians and Gynecologists Committee on Health Care for Underserved Women. ACOG Committee Opinion No. 530: access to postpartum sterilization. Obstet Gynecol. 2012;120(1):212–215.
Educate the sexual partners of at-risk women
It always strikes me how little emphasis is placed on including the sexual partners of women with serious medical problems in the dialogue about responsibility for at-risk pregnancy. As advocates for women’s health, we should educate the couple about vasectomy and liberally provide referrals. Community outreach to help men understand how they can protect their partner from potentially dangerous unwanted pregnancy is extremely important and not stressed enough. Vasectomy is a quick, safe procedure performed in a physician’s office under local anesthesia. Why should any woman who has already risked her life carrying and delivering a baby be required to bear the contraceptive burden when there is a safe and convenient alternative?
Emily Gubert, MD
East Islip, New York
Dr. Barbieri responds
I thank Drs. Will, Mariona, and Gubert and the anonymous author for their wonderful recommendations on approaches to help improve contraceptive care for women. I agree with Dr. Will that the EHR is a valuable tool to advance contraceptive care. The anonymous author and Dr. Mariona make the critically important point that all women should have access to desired contraception without any barriers based on institutional beliefs or government regulations. The patient’s needs should be prioritized in all medical decision making. I agree with Dr. Gubert that including the male partner in the care process is an important part of effective contraception for women. I enthusiastically agree with her that the best permanent contraceptive for a stable couple is vasectomy.
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.
Do antidepressants really cause autism?
Presently it seems that anything a pregnant woman ingests can be correlated with a teratology or an unfortunate neurobehavioral outcome. In an era when up to 15% of pregnant women are taking antidepressant therapy, antidepressants are obvious drugs to be correlated with an untoward fetal outcome, despite the fact that untreated maternal depression itself is significantly worse.1
A recent retrospective secondary end point study by Boukhris and colleagues on antidepressant use in pregnancy and the risk of autism spectrum disorder (ASD) in children is an example of correlation without substantive evidence of causation. Although this study received media attention,2 it is a “data-dredge” study. While the authors correctly note that the database is derived from a prospective registry-based population-based cohort study (the Quebec Pregnancy/Children Cohort), their study’s design more closely resembles a post hoc nested case-control study.
Details of the study
Researchers evaluated data from 145,456 singleton full-term infants born alive between January 1, 1998, and December 31, 2009, with antidepressant exposure during pregnancy defined according to trimester and specific antidepressant classes. Children were considered as having autism if they had received at least 1 autism diagnosis between their date of birth and the last date of follow-up.
We perceive several problems in the study’s design and the authors’ conclusions.
Shortcomings of study design
The study results are based on a post hoc analysis. Autism spectrum disorder was not the primary end point of interest in this database. Accordingly, in a secondary end point study, the risk for bias and confounding is substantial. This study design cannot prove causation.3–5
Exposure is defined by number of antidepressant prescriptions filled. No data regarding adherence (true exposure) are provided. Many women will not take antidepressant drugs as prescribed during pregnancy. It has been reported that antidepressants dispensed to pregnant women during the last 2 trimesters of pregnancy were taken by only 55% of the women.6
The specific antidepressant agents and dosages used were not identified, and the study provided no good sense of duration of use. Is it biologically plausible, therefore, to suggest that all antidepressants—with their disparate structures and mechanisms, in all doses, and for various durations of use—have a uniform effect on fetal neurodevelopment?
Notably, in another prescription drug study of 668,468 pregnancies in 2013, investigators found no significant association between prenatal exposure to antidepressants and ASD.7
Some data suggest that ASD and depression may share preexisting risk factors.8 The increased risk for ASD proposed by Boukhris and colleagues’ study cannot likely be separated from the well-described genetic risk of ASD that might be shared with that of depression.9,10
The stated hazard ratios (HRs) are all <2.2. Given this study’s design, it is plausible that various biases and confounders account for these findings. True significance of these HRs are suspect unless they exceed 3.0, and there is a greater probability of avoiding a type I error when the risk ratios are greater than 4 to 5.3,4
What this evidence means for practice
In this registry-based study of an ongoing population-based cohort, the authors suggest a sensational 87% increased risk of ASD with use of antidepressants during pregnancy. While technically correct, the absolute risk (if real) is really less than 1%. Using sound epidemiologic principles, we would advise against speculating on a number needed to harm based on this study design. Such a projection would require a prospective randomized trial.
—Robert P. Kauffman, MD; Teresa Baker, MD; and Thomas W. Hale, PhD
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.
- Dawson AL, Ailes EC, Gilboa SM, et al. Antidepressant prescription claims among reproductive-aged women with private employer-sponsored insurance--United States 2008 -2013. MMWR Morb Mortal Wkly Rep. 2016;65(3):41–46.
- Cha AE. Maternal exposure to anti-depressant SSRIs linked to autism in children. https://www.washingtonpost.com/news/to-your-health/wp/2015/12/14/maternal-exposure-to-anti-depressant-ssris-linked-to-autism-in-children/. Published December 17, 2015. Accessed March 13, 2017.
- Taubes G. Epidemiology faces its limits. Science. 1995;269(5221):164–169.
- Grimes DA, Schulz KF. False alarms and pseudo-epidemics: the limitations of observational epidemiology. Obstet Gynecol. 2012;120(4):920–927.
- Smith GD, Ebrahim S. Data dredging, bias, and confounding: they can all get you into the BMJ and the Friday papers. BMJ. 2002;325(7378):1437–1438.
- Källén B, Nilsson E, Olausson PO. Antidepressant use during pregnancy: comparison of data obtained from a prescription register and from antenatal care records. Eur J Clin Pharmacol. 2011;67(8):839–845.
- Sørensen MJ, Grønborg TK, Christensen J, et al. Antidepressant exposure in pregnancy and risk of autism spectrum disorders. Clin Epidemiol. 2013;5:449–459.
- King BH. Assessing risk of autism spectrum disorder in children after antidepressant use during pregnancy. JAMA Pediatr. 2016;170(2):111–112.
- Daniels JL, Forssen U, Hultman CM, et al. Parental psychiatric disorders associated with autism spectrum disorders in the offspring. Pediatrics. 2008;121(5):e1357–e1362.
- Lugnegård T, Hallerbäck MU, Gillberg C. Psychiatric comorbidity in young adults with a clinical diagnosis of Asperger syndrome. Res Dev Disabil. 2011;32(5):1910–1917.
Presently it seems that anything a pregnant woman ingests can be correlated with a teratology or an unfortunate neurobehavioral outcome. In an era when up to 15% of pregnant women are taking antidepressant therapy, antidepressants are obvious drugs to be correlated with an untoward fetal outcome, despite the fact that untreated maternal depression itself is significantly worse.1
A recent retrospective secondary end point study by Boukhris and colleagues on antidepressant use in pregnancy and the risk of autism spectrum disorder (ASD) in children is an example of correlation without substantive evidence of causation. Although this study received media attention,2 it is a “data-dredge” study. While the authors correctly note that the database is derived from a prospective registry-based population-based cohort study (the Quebec Pregnancy/Children Cohort), their study’s design more closely resembles a post hoc nested case-control study.
Details of the study
Researchers evaluated data from 145,456 singleton full-term infants born alive between January 1, 1998, and December 31, 2009, with antidepressant exposure during pregnancy defined according to trimester and specific antidepressant classes. Children were considered as having autism if they had received at least 1 autism diagnosis between their date of birth and the last date of follow-up.
We perceive several problems in the study’s design and the authors’ conclusions.
Shortcomings of study design
The study results are based on a post hoc analysis. Autism spectrum disorder was not the primary end point of interest in this database. Accordingly, in a secondary end point study, the risk for bias and confounding is substantial. This study design cannot prove causation.3–5
Exposure is defined by number of antidepressant prescriptions filled. No data regarding adherence (true exposure) are provided. Many women will not take antidepressant drugs as prescribed during pregnancy. It has been reported that antidepressants dispensed to pregnant women during the last 2 trimesters of pregnancy were taken by only 55% of the women.6
The specific antidepressant agents and dosages used were not identified, and the study provided no good sense of duration of use. Is it biologically plausible, therefore, to suggest that all antidepressants—with their disparate structures and mechanisms, in all doses, and for various durations of use—have a uniform effect on fetal neurodevelopment?
Notably, in another prescription drug study of 668,468 pregnancies in 2013, investigators found no significant association between prenatal exposure to antidepressants and ASD.7
Some data suggest that ASD and depression may share preexisting risk factors.8 The increased risk for ASD proposed by Boukhris and colleagues’ study cannot likely be separated from the well-described genetic risk of ASD that might be shared with that of depression.9,10
The stated hazard ratios (HRs) are all <2.2. Given this study’s design, it is plausible that various biases and confounders account for these findings. True significance of these HRs are suspect unless they exceed 3.0, and there is a greater probability of avoiding a type I error when the risk ratios are greater than 4 to 5.3,4
What this evidence means for practice
In this registry-based study of an ongoing population-based cohort, the authors suggest a sensational 87% increased risk of ASD with use of antidepressants during pregnancy. While technically correct, the absolute risk (if real) is really less than 1%. Using sound epidemiologic principles, we would advise against speculating on a number needed to harm based on this study design. Such a projection would require a prospective randomized trial.
—Robert P. Kauffman, MD; Teresa Baker, MD; and Thomas W. Hale, PhD
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.
Presently it seems that anything a pregnant woman ingests can be correlated with a teratology or an unfortunate neurobehavioral outcome. In an era when up to 15% of pregnant women are taking antidepressant therapy, antidepressants are obvious drugs to be correlated with an untoward fetal outcome, despite the fact that untreated maternal depression itself is significantly worse.1
A recent retrospective secondary end point study by Boukhris and colleagues on antidepressant use in pregnancy and the risk of autism spectrum disorder (ASD) in children is an example of correlation without substantive evidence of causation. Although this study received media attention,2 it is a “data-dredge” study. While the authors correctly note that the database is derived from a prospective registry-based population-based cohort study (the Quebec Pregnancy/Children Cohort), their study’s design more closely resembles a post hoc nested case-control study.
Details of the study
Researchers evaluated data from 145,456 singleton full-term infants born alive between January 1, 1998, and December 31, 2009, with antidepressant exposure during pregnancy defined according to trimester and specific antidepressant classes. Children were considered as having autism if they had received at least 1 autism diagnosis between their date of birth and the last date of follow-up.
We perceive several problems in the study’s design and the authors’ conclusions.
Shortcomings of study design
The study results are based on a post hoc analysis. Autism spectrum disorder was not the primary end point of interest in this database. Accordingly, in a secondary end point study, the risk for bias and confounding is substantial. This study design cannot prove causation.3–5
Exposure is defined by number of antidepressant prescriptions filled. No data regarding adherence (true exposure) are provided. Many women will not take antidepressant drugs as prescribed during pregnancy. It has been reported that antidepressants dispensed to pregnant women during the last 2 trimesters of pregnancy were taken by only 55% of the women.6
The specific antidepressant agents and dosages used were not identified, and the study provided no good sense of duration of use. Is it biologically plausible, therefore, to suggest that all antidepressants—with their disparate structures and mechanisms, in all doses, and for various durations of use—have a uniform effect on fetal neurodevelopment?
Notably, in another prescription drug study of 668,468 pregnancies in 2013, investigators found no significant association between prenatal exposure to antidepressants and ASD.7
Some data suggest that ASD and depression may share preexisting risk factors.8 The increased risk for ASD proposed by Boukhris and colleagues’ study cannot likely be separated from the well-described genetic risk of ASD that might be shared with that of depression.9,10
The stated hazard ratios (HRs) are all <2.2. Given this study’s design, it is plausible that various biases and confounders account for these findings. True significance of these HRs are suspect unless they exceed 3.0, and there is a greater probability of avoiding a type I error when the risk ratios are greater than 4 to 5.3,4
What this evidence means for practice
In this registry-based study of an ongoing population-based cohort, the authors suggest a sensational 87% increased risk of ASD with use of antidepressants during pregnancy. While technically correct, the absolute risk (if real) is really less than 1%. Using sound epidemiologic principles, we would advise against speculating on a number needed to harm based on this study design. Such a projection would require a prospective randomized trial.
—Robert P. Kauffman, MD; Teresa Baker, MD; and Thomas W. Hale, PhD
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.
- Dawson AL, Ailes EC, Gilboa SM, et al. Antidepressant prescription claims among reproductive-aged women with private employer-sponsored insurance--United States 2008 -2013. MMWR Morb Mortal Wkly Rep. 2016;65(3):41–46.
- Cha AE. Maternal exposure to anti-depressant SSRIs linked to autism in children. https://www.washingtonpost.com/news/to-your-health/wp/2015/12/14/maternal-exposure-to-anti-depressant-ssris-linked-to-autism-in-children/. Published December 17, 2015. Accessed March 13, 2017.
- Taubes G. Epidemiology faces its limits. Science. 1995;269(5221):164–169.
- Grimes DA, Schulz KF. False alarms and pseudo-epidemics: the limitations of observational epidemiology. Obstet Gynecol. 2012;120(4):920–927.
- Smith GD, Ebrahim S. Data dredging, bias, and confounding: they can all get you into the BMJ and the Friday papers. BMJ. 2002;325(7378):1437–1438.
- Källén B, Nilsson E, Olausson PO. Antidepressant use during pregnancy: comparison of data obtained from a prescription register and from antenatal care records. Eur J Clin Pharmacol. 2011;67(8):839–845.
- Sørensen MJ, Grønborg TK, Christensen J, et al. Antidepressant exposure in pregnancy and risk of autism spectrum disorders. Clin Epidemiol. 2013;5:449–459.
- King BH. Assessing risk of autism spectrum disorder in children after antidepressant use during pregnancy. JAMA Pediatr. 2016;170(2):111–112.
- Daniels JL, Forssen U, Hultman CM, et al. Parental psychiatric disorders associated with autism spectrum disorders in the offspring. Pediatrics. 2008;121(5):e1357–e1362.
- Lugnegård T, Hallerbäck MU, Gillberg C. Psychiatric comorbidity in young adults with a clinical diagnosis of Asperger syndrome. Res Dev Disabil. 2011;32(5):1910–1917.
- Dawson AL, Ailes EC, Gilboa SM, et al. Antidepressant prescription claims among reproductive-aged women with private employer-sponsored insurance--United States 2008 -2013. MMWR Morb Mortal Wkly Rep. 2016;65(3):41–46.
- Cha AE. Maternal exposure to anti-depressant SSRIs linked to autism in children. https://www.washingtonpost.com/news/to-your-health/wp/2015/12/14/maternal-exposure-to-anti-depressant-ssris-linked-to-autism-in-children/. Published December 17, 2015. Accessed March 13, 2017.
- Taubes G. Epidemiology faces its limits. Science. 1995;269(5221):164–169.
- Grimes DA, Schulz KF. False alarms and pseudo-epidemics: the limitations of observational epidemiology. Obstet Gynecol. 2012;120(4):920–927.
- Smith GD, Ebrahim S. Data dredging, bias, and confounding: they can all get you into the BMJ and the Friday papers. BMJ. 2002;325(7378):1437–1438.
- Källén B, Nilsson E, Olausson PO. Antidepressant use during pregnancy: comparison of data obtained from a prescription register and from antenatal care records. Eur J Clin Pharmacol. 2011;67(8):839–845.
- Sørensen MJ, Grønborg TK, Christensen J, et al. Antidepressant exposure in pregnancy and risk of autism spectrum disorders. Clin Epidemiol. 2013;5:449–459.
- King BH. Assessing risk of autism spectrum disorder in children after antidepressant use during pregnancy. JAMA Pediatr. 2016;170(2):111–112.
- Daniels JL, Forssen U, Hultman CM, et al. Parental psychiatric disorders associated with autism spectrum disorders in the offspring. Pediatrics. 2008;121(5):e1357–e1362.
- Lugnegård T, Hallerbäck MU, Gillberg C. Psychiatric comorbidity in young adults with a clinical diagnosis of Asperger syndrome. Res Dev Disabil. 2011;32(5):1910–1917.