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Proclivity ID
18818001
Unpublish
Specialty Focus
Mental Health
Vaccines
Addiction Medicine
Geriatrics
Negative Keywords
gaming
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
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rumprammerer
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rums
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ruskiing
ruskily
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scaged
scager
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scaging
scagly
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scantily
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scantilyer
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scantilying
scantilyly
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schlonged
schlonger
schlonges
schlonging
schlongly
schlongs
scrog
scroged
scroger
scroges
scroging
scrogly
scrogs
scrot
scrote
scroted
scroteed
scroteer
scrotees
scroteing
scrotely
scroter
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scroting
scrotly
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scrotumed
scrotumer
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scrotuming
scrotumly
scrotums
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scruded
scruder
scrudes
scruding
scrudly
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scumer
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scuming
scumly
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seamanly
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seamener
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seamenly
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seduceer
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seduceing
seducely
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semened
semener
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semening
semenly
semens
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shamedamees
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shamedamely
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shit
shite
shiteater
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shiteaterer
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shiteaterly
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shites
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shitheader
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shithousely
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shitly
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shitted
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shittes
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shittly
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shittyly
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shized
shizer
shizes
shizing
shizly
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shooted
shooter
shootes
shooting
shootly
shoots
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sissyed
sissyer
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sissying
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skager
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skaging
skagly
skags
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skanker
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skanking
skankly
skanks
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slaveed
slaveer
slavees
slaveing
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spicer
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spicker
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spickly
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spoogees
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spoogely
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spunked
spunker
spunkes
spunking
spunkly
spunks
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steamyer
steamyes
steamying
steamyly
steamys
stfu
stfued
stfuer
stfues
stfuing
stfuly
stfus
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stiffyes
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stiffyly
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stonedly
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stupidly
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suckes
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suckinger
suckinges
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suckingly
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suckly
sucks
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sumofabiatching
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tarded
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tardes
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tawdryes
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tawdryly
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teabagginger
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teabaggingly
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terded
terder
terdes
terding
terdly
terds
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testee
testeed
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testeely
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testees
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testely
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testesly
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testiclely
testicles
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testised
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testises
testising
testisly
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thruster
thrustes
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thrustly
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thuger
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thugly
thugs
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tinkleed
tinkleer
tinklees
tinkleing
tinklely
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tit
tited
titer
tites
titfuck
titfucked
titfucker
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titfucking
titfuckly
titfucks
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titied
titier
tities
titiing
titily
titing
titis
titly
tits
titsed
titser
titses
titsing
titsly
titss
tittiefucker
tittiefuckered
tittiefuckerer
tittiefuckeres
tittiefuckering
tittiefuckerly
tittiefuckers
titties
tittiesed
tittieser
tittieses
tittiesing
tittiesly
tittiess
titty
tittyed
tittyer
tittyes
tittyfuck
tittyfucked
tittyfucker
tittyfuckered
tittyfuckerer
tittyfuckeres
tittyfuckering
tittyfuckerly
tittyfuckers
tittyfuckes
tittyfucking
tittyfuckly
tittyfucks
tittying
tittyly
tittys
toke
tokeed
tokeer
tokees
tokeing
tokely
tokes
toots
tootsed
tootser
tootses
tootsing
tootsly
tootss
tramp
tramped
tramper
trampes
tramping
tramply
tramps
transsexualed
transsexualer
transsexuales
transsexualing
transsexually
transsexuals
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trashyed
trashyer
trashyes
trashying
trashyly
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tubgirl
tubgirled
tubgirler
tubgirles
tubgirling
tubgirlly
tubgirls
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turded
turder
turdes
turding
turdly
turds
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tushed
tusher
tushes
tushing
tushly
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twater
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twatly
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twatser
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uzied
uzier
uzies
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uzily
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vaged
vager
vages
vaging
vagly
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valiumed
valiumer
valiumes
valiuming
valiumly
valiums
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virgined
virginer
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virgining
virginly
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vixen
vixened
vixener
vixenes
vixening
vixenly
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vodkaer
vodkaes
vodkaing
vodkaly
vodkas
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voyeured
voyeurer
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voyeuring
voyeurly
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vulgared
vulgarer
vulgares
vulgaring
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wang
wanged
wanger
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wanging
wangly
wangs
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wanked
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wankerer
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wankerly
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wanking
wankly
wanks
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wazooed
wazooer
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wazooing
wazooly
wazoos
wedgie
wedgieed
wedgieer
wedgiees
wedgieing
wedgiely
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weeder
weedes
weeding
weedly
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weenie
weenieed
weenieer
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weenieing
weeniely
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weewee
weeweeed
weeweeer
weeweees
weeweeing
weeweely
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weiner
weinered
weinerer
weineres
weinering
weinerly
weiners
weirdo
weirdoed
weirdoer
weirdoes
weirdoing
weirdoly
weirdos
wench
wenched
wencher
wenches
wenching
wenchly
wenchs
wetback
wetbacked
wetbacker
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wetbacking
wetbackly
wetbacks
whitey
whiteyed
whiteyer
whiteyes
whiteying
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whized
whizer
whizes
whizing
whizly
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whoralicioused
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whoraliciousing
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whore
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whorealicioused
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whorealiciousing
whorealiciously
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whoreded
whoreder
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whoreding
whoredly
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whorefaceed
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whorefaceing
whorefacely
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whorehopper
whorehoppered
whorehopperer
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whorehoppering
whorehopperly
whorehoppers
whorehouse
whorehouseed
whorehouseer
whorehousees
whorehouseing
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whoreing
whorely
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whoresed
whoreser
whoreses
whoresing
whoresly
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whoringing
whoringly
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wigger
wiggered
wiggerer
wiggeres
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wiggerly
wiggers
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woodyed
woodyer
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woodying
woodyly
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woped
woper
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woping
woply
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wtf
wtfed
wtfer
wtfes
wtfing
wtfly
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xxx
xxxed
xxxer
xxxes
xxxing
xxxly
xxxs
yeasty
yeastyed
yeastyer
yeastyes
yeastying
yeastyly
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yobbo
yobboed
yobboer
yobboes
yobboing
yobboly
yobbos
zoophile
zoophileed
zoophileer
zoophilees
zoophileing
zoophilely
zoophiles
anal
ass
ass lick
balls
ballsac
bisexual
bleach
causas
cheap
cost of miracles
cunt
display network stats
fart
fda and death
fda AND warn
fda AND warning
fda AND warns
feom
fuck
gfc
humira AND expensive
illegal
madvocate
masturbation
nuccitelli
overdose
porn
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snort
texarkana
effective for the treatment of a baby
effective for the treatment of a boy
effective for the treatment of a child
effective for the treatment of a female
effective for the treatment of a girl
effective for the treatment of a kid
effective for the treatment of a minor
effective for the treatment of a newborn
effective for the treatment of a teen
effective for the treatment of a teenager
effective for the treatment of a toddler
effective for the treatment of a woman
effective for the treatment of adolescents
effective for the treatment of an adolescent
effective for the treatment of an infant
effective for the treatment of babies
effective for the treatment of baby
effective for the treatment of body building
effective for the treatment of boys
effective for the treatment of breast feeding
effective for the treatment of children
effective for the treatment of females
effective for the treatment of fetus
effective for the treatment of girls
effective for the treatment of infants
effective for the treatment of kids
effective for the treatment of minors
effective for the treatment of newborn
effective for the treatment of pediatric
effective for the treatment of pregnancy
effective for the treatment of pregnant
effective for the treatment of teenagers
effective for the treatment of teens
effective for the treatment of toddlers
effective for the treatment of women
effective for the treatment of youths
for the relief of a baby
for the relief of a boy
for the relief of a child
for the relief of a female
for the relief of a girl
for the relief of a kid
for the relief of a minor
for the relief of a newborn
for the relief of a teen
for the relief of a teenager
for the relief of a toddler
for the relief of a woman
for the relief of adolescents
for the relief of an adolescent
for the relief of an infant
for the relief of babies
for the relief of baby
for the relief of body building
for the relief of boys
for the relief of breast feeding
for the relief of children
for the relief of females
for the relief of fetus
for the relief of girls
for the relief of infants
for the relief of kids
for the relief of minors
for the relief of newborn
for the relief of pediatric
for the relief of pregnancy
for the relief of pregnant
for the relief of teenagers
for the relief of teens
for the relief of toddlers
for the relief of women
for the relief of youths
medicating a baby
medicating a boy
medicating a child
medicating a female
medicating a girl
medicating a kid
medicating a minor
medicating a newborn
medicating a teen
medicating a teenager
medicating a toddler
medicating a woman
medicating adolescents
medicating an adolescent
medicating an infant
medicating babies
medicating baby
medicating body building
medicating boys
medicating breast feeding
medicating children
medicating females
medicating fetus
medicating girls
medicating infants
medicating kids
medicating minors
medicating newborn
medicating pediatric
medicating pregnancy
medicating pregnant
medicating teenagers
medicating teens
medicating toddlers
medicating women
medicating youths
at risk for a baby
at risk for a boy
at risk for a child
at risk for a female
at risk for a girl
at risk for a kid
at risk for a minor
at risk for a newborn
at risk for a teen
at risk for a teenager
at risk for a toddler
at risk for a woman
at risk for adolescents
at risk for an adolescent
at risk for an infant
at risk for babies
at risk for baby
at risk for body building
at risk for boys
at risk for breast feeding
at risk for children
at risk for females
at risk for fetus
at risk for girls
at risk for infants
at risk for kids
at risk for minors
at risk for newborn
at risk for pediatric
at risk for pregnancy
at risk for pregnant
at risk for teenagers
at risk for teens
at risk for toddlers
at risk for women
at risk for youths
treating a baby
treating a boy
treating a child
treating a female
treating a girl
treating a kid
treating a minor
treating a newborn
treating a teen
treating a teenager
treating a toddler
treating a woman
treating adolescents
treating an adolescent
treating an infant
treating babies
treating baby
treating body building
treating boys
treating breast feeding
treating children
treating females
treating fetus
treating girls
treating infants
treating kids
treating minors
treating newborn
treating pediatric
treating pregnancy
treating pregnant
treating teenagers
treating teens
treating toddlers
treating women
treating youths
treatment for a baby
treatment for a boy
treatment for a child
treatment for a female
treatment for a girl
treatment for a kid
treatment for a minor
treatment for a newborn
treatment for a teen
treatment for a teenager
treatment for a toddler
treatment for a woman
treatment for adolescents
treatment for an adolescent
treatment for an infant
treatment for babies
treatment for baby
treatment for body building
treatment for boys
treatment for breast feeding
treatment for children
treatment for females
treatment for fetus
treatment for girls
treatment for infants
treatment for kids
treatment for minors
treatment for newborn
treatment for pediatric
treatment for pregnancy
treatment for pregnant
treatment for teenagers
treatment for teens
treatment for toddlers
treatment for women
treatment for youths
treatments for a baby
treatments for a boy
treatments for a child
treatments for a female
treatments for a girl
treatments for a kid
treatments for a minor
treatments for a newborn
treatments for a teen
treatments for a teenager
treatments for a toddler
treatments for a woman
treatments for adolescents
treatments for an adolescent
treatments for an infant
treatments for babies
treatments for baby
treatments for body building
treatments for boys
treatments for breast feeding
treatments for children
treatments for females
treatments for fetus
treatments for girls
treatments for infants
treatments for kids
treatments for minors
treatments for newborn
treatments for pediatric
treatments for pregnancy
treatments for pregnant
treatments for teenagers
treatments for teens
treatments for toddlers
treatments for women
treatments for youths
diagnosing a baby
diagnosing a boy
diagnosing a child
diagnosing a female
diagnosing a girl
diagnosing a kid
diagnosing a minor
diagnosing a newborn
diagnosing a teen
diagnosing a teenager
diagnosing a toddler
diagnosing a woman
diagnosing adolescents
diagnosing an adolescent
diagnosing an infant
diagnosing babies
diagnosing baby
diagnosing body building
diagnosing boys
diagnosing breast feeding
diagnosing children
diagnosing females
diagnosing fetus
diagnosing girls
diagnosing infants
diagnosing kids
diagnosing minors
diagnosing newborn
diagnosing pediatric
diagnosing pregnancy
diagnosing pregnant
diagnosing teenagers
diagnosing teens
diagnosing toddlers
diagnosing women
diagnosing youths
indicated for a baby
indicated for a boy
indicated for a child
indicated for a female
indicated for a girl
indicated for a kid
indicated for a minor
indicated for a newborn
indicated for a teen
indicated for a teenager
indicated for a toddler
indicated for a woman
indicated for adolescents
indicated for an adolescent
indicated for an infant
indicated for babies
indicated for baby
indicated for body building
indicated for boys
indicated for breast feeding
indicated for children
indicated for females
indicated for fetus
indicated for girls
indicated for infants
indicated for kids
indicated for minors
indicated for newborn
indicated for pediatric
indicated for pregnancy
indicated for pregnant
indicated for teenagers
indicated for teens
indicated for toddlers
indicated for women
indicated for youths
useful for a baby
useful for a boy
useful for a child
useful for a female
useful for a girl
useful for a kid
useful for a minor
useful for a newborn
useful for a teen
useful for a teenager
useful for a toddler
useful for a woman
useful for adolescents
useful for an adolescent
useful for an infant
useful for babies
useful for baby
useful for body building
useful for boys
useful for breast feeding
useful for children
useful for females
useful for fetus
useful for girls
useful for infants
useful for kids
useful for minors
useful for newborn
useful for pediatric
useful for pregnancy
useful for pregnant
useful for teenagers
useful for teens
useful for toddlers
useful for women
useful for youths
effective for a baby
effective for a boy
effective for a child
effective for a female
effective for a girl
effective for a kid
effective for a minor
effective for a newborn
effective for a teen
effective for a teenager
effective for a toddler
effective for a woman
effective for adolescents
effective for an adolescent
effective for an infant
effective for babies
effective for baby
effective for body building
effective for boys
effective for breast feeding
effective for children
effective for females
effective for fetus
effective for girls
effective for infants
effective for kids
effective for minors
effective for newborn
effective for pediatric
effective for pregnancy
effective for pregnant
effective for teenagers
effective for teens
effective for toddlers
effective for women
effective for youths
cures for a baby
cures for a boy
cures for a child
cures for a female
cures for a girl
cures for a kid
cures for a minor
cures for a newborn
cures for a teen
cures for a teenager
cures for a toddler
cures for a woman
cures for adolescents
cures for an adolescent
cures for an infant
cures for babies
cures for baby
cures for body building
cures for boys
cures for breast feeding
cures for children
cures for females
cures for fetus
cures for girls
cures for infants
cures for kids
cures for minors
cures for newborn
cures for pediatric
cures for pregnancy
cures for pregnant
cures for teenagers
cures for teens
cures for toddlers
cures for women
cures for youths
use in a baby
use in a boy
use in a child
use in a female
use in a girl
use in a kid
use in a minor
use in a newborn
use in a teen
use in a teenager
use in a toddler
use in a woman
use in adolescents
use in an adolescent
use in an infant
use in babies
use in baby
use in body building
use in boys
use in breast feeding
use in children
use in females
use in fetus
use in girls
use in infants
use in kids
use in minors
use in newborn
use in pediatric
use in pregnancy
use in pregnant
use in teenagers
use in teens
use in toddlers
use in women
use in youths
use in patients with a baby
use in patients with a boy
use in patients with a child
use in patients with a female
use in patients with a girl
use in patients with a kid
use in patients with a minor
use in patients with a newborn
use in patients with a teen
use in patients with a teenager
use in patients with a toddler
use in patients with a woman
use in patients with adolescents
use in patients with an adolescent
use in patients with an infant
use in patients with babies
use in patients with baby
use in patients with body building
use in patients with boys
use in patients with breast feeding
use in patients with children
use in patients with females
use in patients with fetus
use in patients with girls
use in patients with infants
use in patients with kids
use in patients with minors
use in patients with newborn
use in patients with pediatric
use in patients with pregnancy
use in patients with pregnant
use in patients with teenagers
use in patients with teens
use in patients with toddlers
use in patients with women
use in patients with youths
a baby diagnosis
a boy diagnosis
a child diagnosis
a female diagnosis
a girl diagnosis
a kid diagnosis
a minor diagnosis
a newborn diagnosis
a teen diagnosis
a teenager diagnosis
a toddler diagnosis
a woman diagnosis
adolescents diagnosis
an adolescent diagnosis
an infant diagnosis
babies diagnosis
baby diagnosis
body building diagnosis
boys diagnosis
breast feeding diagnosis
children diagnosis
females diagnosis
fetus diagnosis
girls diagnosis
infants diagnosis
kids diagnosis
minors diagnosis
newborn diagnosis
pediatric diagnosis
pregnancy diagnosis
pregnant diagnosis
teenagers diagnosis
teens diagnosis
toddlers diagnosis
women diagnosis
youths diagnosis
a baby medication
a boy medication
a child medication
a female medication
a girl medication
a kid medication
a minor medication
a newborn medication
a teen medication
a teenager medication
a toddler medication
a woman medication
adolescents medication
an adolescent medication
an infant medication
babies medication
baby medication
body building medication
boys medication
breast feeding medication
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Canadian Guideline on Managing Opioid Use Disorder Updated

Article Type
Changed
Thu, 11/14/2024 - 22:35

Canada’s National Guideline for the Clinical Management of Opioid Use Disorder (OUD) has been updated to reflect the latest literature. The new document recommends buprenorphine and methadone as first-line treatments for OUD.

Opioid use and OUD remain the leading causes of drug-related death worldwide. In Canada, the number of apparent opioid-related deaths increased from 2831 in 2016 to 8049 in 2023. Despite the expansion of treatment options, including the lifting of restrictions on methadone prescribing in 2018, there has been a substantial surge in opioid-related harms, the authors wrote.

“OUD and opioid-related harms have devastating outcomes for our communities across Canada,” author Ginette Poulin, MD, a family physician at the University of Manitoba in Winnipeg, Manitoba, Canada, said in a statement. “With the growing dangers associated with the illicit market, we need to ensure we are sharing the most relevant therapeutic tools and up-to-date knowledge to help providers and communities address this complex issue.”

The 2024 update, which was drafted by the Canadian Research Initiative in Substance Matters (CRISM), was published  in CMAJ.

 

Expanding Access

The COVID-19 pandemic marked an increase in opioid-related harms, senior author Julie Bruneau, MD, Canada research chair in addiction medicine and professor of family and emergency medicine at the Université de Montréal, in Quebec, Canada, told this news organization. Access to essential services and support for people with OUD became restricted, and the drug supply became toxic and volatile.

“In March 2018, CRISM published the first Canadian national clinical practice guideline to assist clinicians in making informed decisions regarding the clinical management of OUD, and recommendations were made in light of existing evidence on prioritizing available treatments,” said Bruneau.

“This guideline is intended for use by healthcare providers, including physicians, nurse practitioners, pharmacists, clinical psychologists, social workers, medical educators, and clinical care case managers with or without specialized experience in addiction treatment. We hope it will help expand access to evidence-based interventions for people with OUD beyond tertiary care,” she said.

Bruneau added that integrating first-line opioid agonist treatment into primary care could reduce stigma, increase early screening and patient retention, and help reduce Canada’s opioid crisis.

The CRISM guideline development team carried out a comprehensive systematic review of the literature published from January 1, 2017, to September 14, 2023. The team, which included patients with OUD, drafted and graded their recommendations using the Grading of Recommendations, Assessment, Development and Evaluation approach.

“First, OUD management should be based on a patient-centered approach, which includes respect for the patient’s rights, preferences, and dignity,” said Bruneau.

Highlights of the guideline include the following recommendations:

  • Buprenorphine, with or without naloxone, and methadone can be used as standard first-line treatment options.
  • Opioid agonist treatment with slow-release oral morphine should be made available and offered as a second-line option.
  • Patients with OUD should not be offered withdrawal management as stand-alone treatment because it is associated with increased rates of relapse, morbidity, and mortality.
  • Psychosocial treatment, interventions, and supports can be offered as adjunct treatments but should not be a mandatory component of standard treatment for OUD and should not prevent access to opioid agonist therapy.
  • Harm reduction strategies should be offered as part of the continuum of care for patients with OUD.
  • Pregnant people can be offered buprenorphine or methadone as treatment options.

Treating More Patients

“Too many people die from untreated opioid addiction in Canada,” coauthor Peter Selby, MD, director of medical education at the Centre for Addiction and Mental Health, said in a statement. “We have medicines that help people stop using, but too few patients are treated due to stigma and lack of prescribers knowing what to do. These national guidelines help them use proven medications to not only prevent death but also help people recover.”

“That both buprenorphine and methadone are now to be considered first-line therapy for the management of OUD is an important change to the guideline,” said Abhimanyu Sud, MD, PhD, research chair in primary care and population health systems at Humber River Health and assistant professor of family and community medicine at the University of Toronto. He did not participate in drafting the guidelines.

“There is a lot of good evidence that these agents are effective for the management of OUD. We had this idea that methadone was harder or somehow more unsafe than buprenorphine, and that buprenorphine was therefore a safer therapy that should be used more widely. Now we have very high-potency opioids that are circulating, and methadone, as a strong opioid agonist, has an important role to play. Clinical experience has borne that out, and this is reflected in the guidelines,” said Sud. 

“When we treat patients who are using fentanyl, for example, or fentanyl analogs, or they’re not sure what they are using because the drug supply has been so contaminated, you sometimes need another agent. Also, a lot of patients do not respond very well to buprenorphine, so for many people, a full agonist like methadone is needed,” he added.

Giving higher priority to slow-release morphine is a good move, and the drug’s use is likely to be safe when administered by a skilled clinician, said Akash Goel, MD, staff physician in the Department of Anesthesiology and Pain Medicine at St. Michael’s Hospital and assistant professor of anesthesiology and pain medicine at the University of Toronto. Goel was not involved in drafting the guideline. 

The updated document will empower patients to make informed decisions about their care, he said. “Buprenorphine, for example, may not be the right selection for all patients. The updated guideline recognizes this. So, for patients who are at risk of failing OUD therapy and going back to using, buprenorphine may not be the best option. The new guideline gives patients the opportunity to have a conversation with their healthcare providers and then decide what’s the best way forward for them.” 

The guideline was supported by Health Canada and the Canadian Institutes of Health Research (CIHR) via CRISM. Poulin reported receiving honoraria for presentations from the Master Clinician Alliance and Indivior outside this work. Bruneau reported receiving a CIHR research grant and a grant from Health Canada’s Substance Use and Addictions Program. Outside this work, Bruneau received a National Institutes of Health research grant and consulting fees for Gilead Sciences and AbbVie.

A version of this article first appeared on Medscape.com.

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Canada’s National Guideline for the Clinical Management of Opioid Use Disorder (OUD) has been updated to reflect the latest literature. The new document recommends buprenorphine and methadone as first-line treatments for OUD.

Opioid use and OUD remain the leading causes of drug-related death worldwide. In Canada, the number of apparent opioid-related deaths increased from 2831 in 2016 to 8049 in 2023. Despite the expansion of treatment options, including the lifting of restrictions on methadone prescribing in 2018, there has been a substantial surge in opioid-related harms, the authors wrote.

“OUD and opioid-related harms have devastating outcomes for our communities across Canada,” author Ginette Poulin, MD, a family physician at the University of Manitoba in Winnipeg, Manitoba, Canada, said in a statement. “With the growing dangers associated with the illicit market, we need to ensure we are sharing the most relevant therapeutic tools and up-to-date knowledge to help providers and communities address this complex issue.”

The 2024 update, which was drafted by the Canadian Research Initiative in Substance Matters (CRISM), was published  in CMAJ.

 

Expanding Access

The COVID-19 pandemic marked an increase in opioid-related harms, senior author Julie Bruneau, MD, Canada research chair in addiction medicine and professor of family and emergency medicine at the Université de Montréal, in Quebec, Canada, told this news organization. Access to essential services and support for people with OUD became restricted, and the drug supply became toxic and volatile.

“In March 2018, CRISM published the first Canadian national clinical practice guideline to assist clinicians in making informed decisions regarding the clinical management of OUD, and recommendations were made in light of existing evidence on prioritizing available treatments,” said Bruneau.

“This guideline is intended for use by healthcare providers, including physicians, nurse practitioners, pharmacists, clinical psychologists, social workers, medical educators, and clinical care case managers with or without specialized experience in addiction treatment. We hope it will help expand access to evidence-based interventions for people with OUD beyond tertiary care,” she said.

Bruneau added that integrating first-line opioid agonist treatment into primary care could reduce stigma, increase early screening and patient retention, and help reduce Canada’s opioid crisis.

The CRISM guideline development team carried out a comprehensive systematic review of the literature published from January 1, 2017, to September 14, 2023. The team, which included patients with OUD, drafted and graded their recommendations using the Grading of Recommendations, Assessment, Development and Evaluation approach.

“First, OUD management should be based on a patient-centered approach, which includes respect for the patient’s rights, preferences, and dignity,” said Bruneau.

Highlights of the guideline include the following recommendations:

  • Buprenorphine, with or without naloxone, and methadone can be used as standard first-line treatment options.
  • Opioid agonist treatment with slow-release oral morphine should be made available and offered as a second-line option.
  • Patients with OUD should not be offered withdrawal management as stand-alone treatment because it is associated with increased rates of relapse, morbidity, and mortality.
  • Psychosocial treatment, interventions, and supports can be offered as adjunct treatments but should not be a mandatory component of standard treatment for OUD and should not prevent access to opioid agonist therapy.
  • Harm reduction strategies should be offered as part of the continuum of care for patients with OUD.
  • Pregnant people can be offered buprenorphine or methadone as treatment options.

Treating More Patients

“Too many people die from untreated opioid addiction in Canada,” coauthor Peter Selby, MD, director of medical education at the Centre for Addiction and Mental Health, said in a statement. “We have medicines that help people stop using, but too few patients are treated due to stigma and lack of prescribers knowing what to do. These national guidelines help them use proven medications to not only prevent death but also help people recover.”

“That both buprenorphine and methadone are now to be considered first-line therapy for the management of OUD is an important change to the guideline,” said Abhimanyu Sud, MD, PhD, research chair in primary care and population health systems at Humber River Health and assistant professor of family and community medicine at the University of Toronto. He did not participate in drafting the guidelines.

“There is a lot of good evidence that these agents are effective for the management of OUD. We had this idea that methadone was harder or somehow more unsafe than buprenorphine, and that buprenorphine was therefore a safer therapy that should be used more widely. Now we have very high-potency opioids that are circulating, and methadone, as a strong opioid agonist, has an important role to play. Clinical experience has borne that out, and this is reflected in the guidelines,” said Sud. 

“When we treat patients who are using fentanyl, for example, or fentanyl analogs, or they’re not sure what they are using because the drug supply has been so contaminated, you sometimes need another agent. Also, a lot of patients do not respond very well to buprenorphine, so for many people, a full agonist like methadone is needed,” he added.

Giving higher priority to slow-release morphine is a good move, and the drug’s use is likely to be safe when administered by a skilled clinician, said Akash Goel, MD, staff physician in the Department of Anesthesiology and Pain Medicine at St. Michael’s Hospital and assistant professor of anesthesiology and pain medicine at the University of Toronto. Goel was not involved in drafting the guideline. 

The updated document will empower patients to make informed decisions about their care, he said. “Buprenorphine, for example, may not be the right selection for all patients. The updated guideline recognizes this. So, for patients who are at risk of failing OUD therapy and going back to using, buprenorphine may not be the best option. The new guideline gives patients the opportunity to have a conversation with their healthcare providers and then decide what’s the best way forward for them.” 

The guideline was supported by Health Canada and the Canadian Institutes of Health Research (CIHR) via CRISM. Poulin reported receiving honoraria for presentations from the Master Clinician Alliance and Indivior outside this work. Bruneau reported receiving a CIHR research grant and a grant from Health Canada’s Substance Use and Addictions Program. Outside this work, Bruneau received a National Institutes of Health research grant and consulting fees for Gilead Sciences and AbbVie.

A version of this article first appeared on Medscape.com.

Canada’s National Guideline for the Clinical Management of Opioid Use Disorder (OUD) has been updated to reflect the latest literature. The new document recommends buprenorphine and methadone as first-line treatments for OUD.

Opioid use and OUD remain the leading causes of drug-related death worldwide. In Canada, the number of apparent opioid-related deaths increased from 2831 in 2016 to 8049 in 2023. Despite the expansion of treatment options, including the lifting of restrictions on methadone prescribing in 2018, there has been a substantial surge in opioid-related harms, the authors wrote.

“OUD and opioid-related harms have devastating outcomes for our communities across Canada,” author Ginette Poulin, MD, a family physician at the University of Manitoba in Winnipeg, Manitoba, Canada, said in a statement. “With the growing dangers associated with the illicit market, we need to ensure we are sharing the most relevant therapeutic tools and up-to-date knowledge to help providers and communities address this complex issue.”

The 2024 update, which was drafted by the Canadian Research Initiative in Substance Matters (CRISM), was published  in CMAJ.

 

Expanding Access

The COVID-19 pandemic marked an increase in opioid-related harms, senior author Julie Bruneau, MD, Canada research chair in addiction medicine and professor of family and emergency medicine at the Université de Montréal, in Quebec, Canada, told this news organization. Access to essential services and support for people with OUD became restricted, and the drug supply became toxic and volatile.

“In March 2018, CRISM published the first Canadian national clinical practice guideline to assist clinicians in making informed decisions regarding the clinical management of OUD, and recommendations were made in light of existing evidence on prioritizing available treatments,” said Bruneau.

“This guideline is intended for use by healthcare providers, including physicians, nurse practitioners, pharmacists, clinical psychologists, social workers, medical educators, and clinical care case managers with or without specialized experience in addiction treatment. We hope it will help expand access to evidence-based interventions for people with OUD beyond tertiary care,” she said.

Bruneau added that integrating first-line opioid agonist treatment into primary care could reduce stigma, increase early screening and patient retention, and help reduce Canada’s opioid crisis.

The CRISM guideline development team carried out a comprehensive systematic review of the literature published from January 1, 2017, to September 14, 2023. The team, which included patients with OUD, drafted and graded their recommendations using the Grading of Recommendations, Assessment, Development and Evaluation approach.

“First, OUD management should be based on a patient-centered approach, which includes respect for the patient’s rights, preferences, and dignity,” said Bruneau.

Highlights of the guideline include the following recommendations:

  • Buprenorphine, with or without naloxone, and methadone can be used as standard first-line treatment options.
  • Opioid agonist treatment with slow-release oral morphine should be made available and offered as a second-line option.
  • Patients with OUD should not be offered withdrawal management as stand-alone treatment because it is associated with increased rates of relapse, morbidity, and mortality.
  • Psychosocial treatment, interventions, and supports can be offered as adjunct treatments but should not be a mandatory component of standard treatment for OUD and should not prevent access to opioid agonist therapy.
  • Harm reduction strategies should be offered as part of the continuum of care for patients with OUD.
  • Pregnant people can be offered buprenorphine or methadone as treatment options.

Treating More Patients

“Too many people die from untreated opioid addiction in Canada,” coauthor Peter Selby, MD, director of medical education at the Centre for Addiction and Mental Health, said in a statement. “We have medicines that help people stop using, but too few patients are treated due to stigma and lack of prescribers knowing what to do. These national guidelines help them use proven medications to not only prevent death but also help people recover.”

“That both buprenorphine and methadone are now to be considered first-line therapy for the management of OUD is an important change to the guideline,” said Abhimanyu Sud, MD, PhD, research chair in primary care and population health systems at Humber River Health and assistant professor of family and community medicine at the University of Toronto. He did not participate in drafting the guidelines.

“There is a lot of good evidence that these agents are effective for the management of OUD. We had this idea that methadone was harder or somehow more unsafe than buprenorphine, and that buprenorphine was therefore a safer therapy that should be used more widely. Now we have very high-potency opioids that are circulating, and methadone, as a strong opioid agonist, has an important role to play. Clinical experience has borne that out, and this is reflected in the guidelines,” said Sud. 

“When we treat patients who are using fentanyl, for example, or fentanyl analogs, or they’re not sure what they are using because the drug supply has been so contaminated, you sometimes need another agent. Also, a lot of patients do not respond very well to buprenorphine, so for many people, a full agonist like methadone is needed,” he added.

Giving higher priority to slow-release morphine is a good move, and the drug’s use is likely to be safe when administered by a skilled clinician, said Akash Goel, MD, staff physician in the Department of Anesthesiology and Pain Medicine at St. Michael’s Hospital and assistant professor of anesthesiology and pain medicine at the University of Toronto. Goel was not involved in drafting the guideline. 

The updated document will empower patients to make informed decisions about their care, he said. “Buprenorphine, for example, may not be the right selection for all patients. The updated guideline recognizes this. So, for patients who are at risk of failing OUD therapy and going back to using, buprenorphine may not be the best option. The new guideline gives patients the opportunity to have a conversation with their healthcare providers and then decide what’s the best way forward for them.” 

The guideline was supported by Health Canada and the Canadian Institutes of Health Research (CIHR) via CRISM. Poulin reported receiving honoraria for presentations from the Master Clinician Alliance and Indivior outside this work. Bruneau reported receiving a CIHR research grant and a grant from Health Canada’s Substance Use and Addictions Program. Outside this work, Bruneau received a National Institutes of Health research grant and consulting fees for Gilead Sciences and AbbVie.

A version of this article first appeared on Medscape.com.

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Goodbye CHADSVASc: Sex Complicates Stroke Risk Scoring in AF

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The European Society of Cardiology (ESC) caused a stir when they recommended in their latest atrial fibrillation (AF) management guideline that gender no longer be included in the decision to initiate oral anticoagulation therapy.

The move aims to level the playing field between men and women and follows a more nuanced understanding of stroke risk in patients with AF, said experts. It also acknowledges the lack of evidence in people receiving cross-sex hormone therapy.

In any case, the guidelines, developed in collaboration with the European Association for Cardio-Thoracic Surgery and published by the European Heart Journal on August 30, simply follow 2023’s US recommendations, they added.

 

One Size Does Not Fit All

So, what to the ESC guidelines actually say?

They underline that, if left untreated, the risk for ischemic stroke is increased fivefold in patients with AF, and the “default approach should therefore be to provide oral anticoagulation to all eligible AF patients, except those at low risk for incident stroke or thromboembolism.”

However, the authors note that there is a lack of strong evidence on how to apply the current risk scores to help inform that decision in real-world patients.

Dipak Kotecha, MBChB, PhD, Professor of Cardiology at the University of Birmingham and University Hospitals Birmingham NHS Foundation Trust, Birmingham, England, and senior author of the ESC guidelines, said in an interview that “the available scores have a relatively poor ability to accurately predict which patients will have a stroke or thromboembolic event.”

Instead, he said “a much better approach is for healthcare professionals to look at each patient’s individual risk factors, using the risk scores to identify those patients that might not benefit from oral anticoagulant therapy.”

For these guidelines, the authors therefore wanted to “move away from a one-size-fits-all” approach, Kotecha said, and instead ensure that more patients can benefit from the new range of direct oral anticoagulants (DOACs) that are easier to take and with much lower chance of side effects or major bleeding.

To achieve this, they separated their clinical recommendations from any particular risk score, and instead focused on the practicalities of implementation.

 

Risk Modifier Vs Risk Factor

To explain their decision the authors highlight that “the most popular risk score” is the CHA2DS2–VASc, which gives a point for female sex, alongside factors such as congestive heart failure, hypertension, and diabetes mellitus, and a sliding scale of points for increasing age.

Kotecha pointed out the score was developed before the DOACs were available and may not account for how risk factors have changed in recent decades.

The result is that CHA2DS2–VASc gives the same number of points to an individual with heart failure or prior transient ischemic attack as to a woman aged less than 65 years, “but the magnitude of increased risk is not the same,” Usha Beth Tedrow, MD, Associate Professor of Medicine, Brigham and Women’s Hospital, Boston, Massachusetts, said in an interview.

As far back as 2018, it was known that “female sex is a risk modifier, rather than a risk factor for stroke in atrial fibrillation,” noted Jose Joglar, MD, lead author of the 2023 ACC/AHA/ACCP/HRS Guideline for the Diagnosis and Management of Atrial Fibrillation said in an interview.

Danish national registry study involving 239,671 AF patients treated between 1997 and 2015, nearly half of whom were women, showed that, at a CHA2DS2–VASc score of 0, the “risk of stroke between men and women is absolutely the same,” he said.

“It is not until after a CHA2DS2–VASc score of 2 that the curves start to separate,” Joglar, Program Director, Clinical Cardiac Electrophysiology Fellowship Program, The University of Texas Southwestern Medical Center, Dallas, continued, “but by then you have already made the decision to anticoagulate.”

More recently, Kotecha and colleagues conducted a population cohort study of the electronic healthcare records of UK primary care patients treated between 2005 and 2020, and identified 78,852 with AF; more than a third were women.

Their analysis, published on September 1, showed that women had a lower adjusted rate of the primary composite outcome of all-cause mortality, ischemic stroke, or arterial thromboembolism, driven by a reduced mortality rate.

“Removal of gender from clinical risk scoring could simplify the approach to which patients with AF should be offered oral anticoagulation,” Kotecha and colleagues concluded.

Joglar clarified that “women are at increased risk for stroke than men” overall, but by the time that risk “becomes manifest, other risk factors have come into play, and they have already met the criteria for anticoagulation.”

The authors of the latest ESC guideline therefore concluded that the “inclusion of gender complicates clinical practice both for healthcare professionals and patients.” Their solution was to remove the question of gender for decisions over initiating oral anticoagulant therapy in clinical practice altogether.

This includes individuals who identify as transgender or are undergoing sex hormone therapy, as all the experts interviewed by Medscape Medical News agreed that there is currently insufficient evidence to know if that affects stroke risk.

Instead, guidelines state that the drugs are “recommended in those with a CHA2DS2-VA score of 2 or more and should be considered in those with a CHA2DS2-VA score of 1, following a patient-centered and shared care approach.”

“Dropping the gender part of the risk score is not really a substantial change” from previous ESC or other guidelines, as different points were required in the past to recommend anticoagulants for women and men, Kotecha said, adding that “making the approach easier for clinicians may avoid penalizing women as well as nonbinary and transgender patients.”

Anne B. Curtis, MD, SUNY Distinguished Professor, Department of Medicine, Jacobs School of Medicine & Biomedical Sciences, University at Buffalo in New York, agreed.

Putting aside the question of female sex, she said that there are not a lot of people under the age of 65 years with “absolutely no risk factors,” and so, “if the only reason you would anticoagulate” someone of that age is because they are a woman that “doesn’t make a lot of sense to me.”

The ESC guidelines are “trying to say, ‘look at the other risk factors, and if anything is there, go ahead and anticoagulate,” Curtis said in an interview.

“It’s actually a very thoughtful decision,” Tedrow said, and not “intended to discount risk in women.” Rather, it’s a statement that acknowledges the problem of recommending anticoagulation therapy in women “for whom it is not appropriate.”

Joglar pointed out that that recommendation, although not characterized in the same way, was in fact included in the 2023 US guidelines.

“We wanted to use a more nuanced approach,” he said, and move away from using CHA2DS2–VASc as the prime determinant of whether to start oral anticoagulation and towards a magnitude risk assessment, in which female sex is seen as a risk modifier.

“The Europeans and the Americans are looking at the same data, so we often reach the same conclusions,” Joglar said, although “we sometimes use different wordings.”

Overall, Kotecha expressed the hope that the move “will lead to better implementation of guidelines, at the end of the day.”

“That’s all we can hope for: Patients will be offered a more individualized approach, leading to more appropriate use of treatment in the right patients.”

The newer direct oral anticoagulation is “a much simpler therapy,” he added. “There is very little monitoring, a similar risk of bleeding as aspirin, and yet the ability to largely prevent the high rate of stroke and thromboembolism associated with atrial fibrillation.”

“So, it’s a big ticket item for our communities and public health, particularly as atrial fibrillation is expected to double in prevalence in the next few decades and evidence is building that it can lead to vascular dementia in the long-term.”

No funding was declared. Kotecha declares relationships with Bayer, Protherics Medicines Development, Boston Scientific, Daiichi Sankyo, Boehringer Ingelheim, BMS-Pfizer Alliance, Amomed, MyoKardia. Curtis declared relationships with Janssen Pharmaceuticals, Medtronic, Abbott. Joglar declared no relevant relationships. Tedrow declared no relevant relationships.

A version of this article appeared on Medscape.com.

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The European Society of Cardiology (ESC) caused a stir when they recommended in their latest atrial fibrillation (AF) management guideline that gender no longer be included in the decision to initiate oral anticoagulation therapy.

The move aims to level the playing field between men and women and follows a more nuanced understanding of stroke risk in patients with AF, said experts. It also acknowledges the lack of evidence in people receiving cross-sex hormone therapy.

In any case, the guidelines, developed in collaboration with the European Association for Cardio-Thoracic Surgery and published by the European Heart Journal on August 30, simply follow 2023’s US recommendations, they added.

 

One Size Does Not Fit All

So, what to the ESC guidelines actually say?

They underline that, if left untreated, the risk for ischemic stroke is increased fivefold in patients with AF, and the “default approach should therefore be to provide oral anticoagulation to all eligible AF patients, except those at low risk for incident stroke or thromboembolism.”

However, the authors note that there is a lack of strong evidence on how to apply the current risk scores to help inform that decision in real-world patients.

Dipak Kotecha, MBChB, PhD, Professor of Cardiology at the University of Birmingham and University Hospitals Birmingham NHS Foundation Trust, Birmingham, England, and senior author of the ESC guidelines, said in an interview that “the available scores have a relatively poor ability to accurately predict which patients will have a stroke or thromboembolic event.”

Instead, he said “a much better approach is for healthcare professionals to look at each patient’s individual risk factors, using the risk scores to identify those patients that might not benefit from oral anticoagulant therapy.”

For these guidelines, the authors therefore wanted to “move away from a one-size-fits-all” approach, Kotecha said, and instead ensure that more patients can benefit from the new range of direct oral anticoagulants (DOACs) that are easier to take and with much lower chance of side effects or major bleeding.

To achieve this, they separated their clinical recommendations from any particular risk score, and instead focused on the practicalities of implementation.

 

Risk Modifier Vs Risk Factor

To explain their decision the authors highlight that “the most popular risk score” is the CHA2DS2–VASc, which gives a point for female sex, alongside factors such as congestive heart failure, hypertension, and diabetes mellitus, and a sliding scale of points for increasing age.

Kotecha pointed out the score was developed before the DOACs were available and may not account for how risk factors have changed in recent decades.

The result is that CHA2DS2–VASc gives the same number of points to an individual with heart failure or prior transient ischemic attack as to a woman aged less than 65 years, “but the magnitude of increased risk is not the same,” Usha Beth Tedrow, MD, Associate Professor of Medicine, Brigham and Women’s Hospital, Boston, Massachusetts, said in an interview.

As far back as 2018, it was known that “female sex is a risk modifier, rather than a risk factor for stroke in atrial fibrillation,” noted Jose Joglar, MD, lead author of the 2023 ACC/AHA/ACCP/HRS Guideline for the Diagnosis and Management of Atrial Fibrillation said in an interview.

Danish national registry study involving 239,671 AF patients treated between 1997 and 2015, nearly half of whom were women, showed that, at a CHA2DS2–VASc score of 0, the “risk of stroke between men and women is absolutely the same,” he said.

“It is not until after a CHA2DS2–VASc score of 2 that the curves start to separate,” Joglar, Program Director, Clinical Cardiac Electrophysiology Fellowship Program, The University of Texas Southwestern Medical Center, Dallas, continued, “but by then you have already made the decision to anticoagulate.”

More recently, Kotecha and colleagues conducted a population cohort study of the electronic healthcare records of UK primary care patients treated between 2005 and 2020, and identified 78,852 with AF; more than a third were women.

Their analysis, published on September 1, showed that women had a lower adjusted rate of the primary composite outcome of all-cause mortality, ischemic stroke, or arterial thromboembolism, driven by a reduced mortality rate.

“Removal of gender from clinical risk scoring could simplify the approach to which patients with AF should be offered oral anticoagulation,” Kotecha and colleagues concluded.

Joglar clarified that “women are at increased risk for stroke than men” overall, but by the time that risk “becomes manifest, other risk factors have come into play, and they have already met the criteria for anticoagulation.”

The authors of the latest ESC guideline therefore concluded that the “inclusion of gender complicates clinical practice both for healthcare professionals and patients.” Their solution was to remove the question of gender for decisions over initiating oral anticoagulant therapy in clinical practice altogether.

This includes individuals who identify as transgender or are undergoing sex hormone therapy, as all the experts interviewed by Medscape Medical News agreed that there is currently insufficient evidence to know if that affects stroke risk.

Instead, guidelines state that the drugs are “recommended in those with a CHA2DS2-VA score of 2 or more and should be considered in those with a CHA2DS2-VA score of 1, following a patient-centered and shared care approach.”

“Dropping the gender part of the risk score is not really a substantial change” from previous ESC or other guidelines, as different points were required in the past to recommend anticoagulants for women and men, Kotecha said, adding that “making the approach easier for clinicians may avoid penalizing women as well as nonbinary and transgender patients.”

Anne B. Curtis, MD, SUNY Distinguished Professor, Department of Medicine, Jacobs School of Medicine & Biomedical Sciences, University at Buffalo in New York, agreed.

Putting aside the question of female sex, she said that there are not a lot of people under the age of 65 years with “absolutely no risk factors,” and so, “if the only reason you would anticoagulate” someone of that age is because they are a woman that “doesn’t make a lot of sense to me.”

The ESC guidelines are “trying to say, ‘look at the other risk factors, and if anything is there, go ahead and anticoagulate,” Curtis said in an interview.

“It’s actually a very thoughtful decision,” Tedrow said, and not “intended to discount risk in women.” Rather, it’s a statement that acknowledges the problem of recommending anticoagulation therapy in women “for whom it is not appropriate.”

Joglar pointed out that that recommendation, although not characterized in the same way, was in fact included in the 2023 US guidelines.

“We wanted to use a more nuanced approach,” he said, and move away from using CHA2DS2–VASc as the prime determinant of whether to start oral anticoagulation and towards a magnitude risk assessment, in which female sex is seen as a risk modifier.

“The Europeans and the Americans are looking at the same data, so we often reach the same conclusions,” Joglar said, although “we sometimes use different wordings.”

Overall, Kotecha expressed the hope that the move “will lead to better implementation of guidelines, at the end of the day.”

“That’s all we can hope for: Patients will be offered a more individualized approach, leading to more appropriate use of treatment in the right patients.”

The newer direct oral anticoagulation is “a much simpler therapy,” he added. “There is very little monitoring, a similar risk of bleeding as aspirin, and yet the ability to largely prevent the high rate of stroke and thromboembolism associated with atrial fibrillation.”

“So, it’s a big ticket item for our communities and public health, particularly as atrial fibrillation is expected to double in prevalence in the next few decades and evidence is building that it can lead to vascular dementia in the long-term.”

No funding was declared. Kotecha declares relationships with Bayer, Protherics Medicines Development, Boston Scientific, Daiichi Sankyo, Boehringer Ingelheim, BMS-Pfizer Alliance, Amomed, MyoKardia. Curtis declared relationships with Janssen Pharmaceuticals, Medtronic, Abbott. Joglar declared no relevant relationships. Tedrow declared no relevant relationships.

A version of this article appeared on Medscape.com.

The European Society of Cardiology (ESC) caused a stir when they recommended in their latest atrial fibrillation (AF) management guideline that gender no longer be included in the decision to initiate oral anticoagulation therapy.

The move aims to level the playing field between men and women and follows a more nuanced understanding of stroke risk in patients with AF, said experts. It also acknowledges the lack of evidence in people receiving cross-sex hormone therapy.

In any case, the guidelines, developed in collaboration with the European Association for Cardio-Thoracic Surgery and published by the European Heart Journal on August 30, simply follow 2023’s US recommendations, they added.

 

One Size Does Not Fit All

So, what to the ESC guidelines actually say?

They underline that, if left untreated, the risk for ischemic stroke is increased fivefold in patients with AF, and the “default approach should therefore be to provide oral anticoagulation to all eligible AF patients, except those at low risk for incident stroke or thromboembolism.”

However, the authors note that there is a lack of strong evidence on how to apply the current risk scores to help inform that decision in real-world patients.

Dipak Kotecha, MBChB, PhD, Professor of Cardiology at the University of Birmingham and University Hospitals Birmingham NHS Foundation Trust, Birmingham, England, and senior author of the ESC guidelines, said in an interview that “the available scores have a relatively poor ability to accurately predict which patients will have a stroke or thromboembolic event.”

Instead, he said “a much better approach is for healthcare professionals to look at each patient’s individual risk factors, using the risk scores to identify those patients that might not benefit from oral anticoagulant therapy.”

For these guidelines, the authors therefore wanted to “move away from a one-size-fits-all” approach, Kotecha said, and instead ensure that more patients can benefit from the new range of direct oral anticoagulants (DOACs) that are easier to take and with much lower chance of side effects or major bleeding.

To achieve this, they separated their clinical recommendations from any particular risk score, and instead focused on the practicalities of implementation.

 

Risk Modifier Vs Risk Factor

To explain their decision the authors highlight that “the most popular risk score” is the CHA2DS2–VASc, which gives a point for female sex, alongside factors such as congestive heart failure, hypertension, and diabetes mellitus, and a sliding scale of points for increasing age.

Kotecha pointed out the score was developed before the DOACs were available and may not account for how risk factors have changed in recent decades.

The result is that CHA2DS2–VASc gives the same number of points to an individual with heart failure or prior transient ischemic attack as to a woman aged less than 65 years, “but the magnitude of increased risk is not the same,” Usha Beth Tedrow, MD, Associate Professor of Medicine, Brigham and Women’s Hospital, Boston, Massachusetts, said in an interview.

As far back as 2018, it was known that “female sex is a risk modifier, rather than a risk factor for stroke in atrial fibrillation,” noted Jose Joglar, MD, lead author of the 2023 ACC/AHA/ACCP/HRS Guideline for the Diagnosis and Management of Atrial Fibrillation said in an interview.

Danish national registry study involving 239,671 AF patients treated between 1997 and 2015, nearly half of whom were women, showed that, at a CHA2DS2–VASc score of 0, the “risk of stroke between men and women is absolutely the same,” he said.

“It is not until after a CHA2DS2–VASc score of 2 that the curves start to separate,” Joglar, Program Director, Clinical Cardiac Electrophysiology Fellowship Program, The University of Texas Southwestern Medical Center, Dallas, continued, “but by then you have already made the decision to anticoagulate.”

More recently, Kotecha and colleagues conducted a population cohort study of the electronic healthcare records of UK primary care patients treated between 2005 and 2020, and identified 78,852 with AF; more than a third were women.

Their analysis, published on September 1, showed that women had a lower adjusted rate of the primary composite outcome of all-cause mortality, ischemic stroke, or arterial thromboembolism, driven by a reduced mortality rate.

“Removal of gender from clinical risk scoring could simplify the approach to which patients with AF should be offered oral anticoagulation,” Kotecha and colleagues concluded.

Joglar clarified that “women are at increased risk for stroke than men” overall, but by the time that risk “becomes manifest, other risk factors have come into play, and they have already met the criteria for anticoagulation.”

The authors of the latest ESC guideline therefore concluded that the “inclusion of gender complicates clinical practice both for healthcare professionals and patients.” Their solution was to remove the question of gender for decisions over initiating oral anticoagulant therapy in clinical practice altogether.

This includes individuals who identify as transgender or are undergoing sex hormone therapy, as all the experts interviewed by Medscape Medical News agreed that there is currently insufficient evidence to know if that affects stroke risk.

Instead, guidelines state that the drugs are “recommended in those with a CHA2DS2-VA score of 2 or more and should be considered in those with a CHA2DS2-VA score of 1, following a patient-centered and shared care approach.”

“Dropping the gender part of the risk score is not really a substantial change” from previous ESC or other guidelines, as different points were required in the past to recommend anticoagulants for women and men, Kotecha said, adding that “making the approach easier for clinicians may avoid penalizing women as well as nonbinary and transgender patients.”

Anne B. Curtis, MD, SUNY Distinguished Professor, Department of Medicine, Jacobs School of Medicine & Biomedical Sciences, University at Buffalo in New York, agreed.

Putting aside the question of female sex, she said that there are not a lot of people under the age of 65 years with “absolutely no risk factors,” and so, “if the only reason you would anticoagulate” someone of that age is because they are a woman that “doesn’t make a lot of sense to me.”

The ESC guidelines are “trying to say, ‘look at the other risk factors, and if anything is there, go ahead and anticoagulate,” Curtis said in an interview.

“It’s actually a very thoughtful decision,” Tedrow said, and not “intended to discount risk in women.” Rather, it’s a statement that acknowledges the problem of recommending anticoagulation therapy in women “for whom it is not appropriate.”

Joglar pointed out that that recommendation, although not characterized in the same way, was in fact included in the 2023 US guidelines.

“We wanted to use a more nuanced approach,” he said, and move away from using CHA2DS2–VASc as the prime determinant of whether to start oral anticoagulation and towards a magnitude risk assessment, in which female sex is seen as a risk modifier.

“The Europeans and the Americans are looking at the same data, so we often reach the same conclusions,” Joglar said, although “we sometimes use different wordings.”

Overall, Kotecha expressed the hope that the move “will lead to better implementation of guidelines, at the end of the day.”

“That’s all we can hope for: Patients will be offered a more individualized approach, leading to more appropriate use of treatment in the right patients.”

The newer direct oral anticoagulation is “a much simpler therapy,” he added. “There is very little monitoring, a similar risk of bleeding as aspirin, and yet the ability to largely prevent the high rate of stroke and thromboembolism associated with atrial fibrillation.”

“So, it’s a big ticket item for our communities and public health, particularly as atrial fibrillation is expected to double in prevalence in the next few decades and evidence is building that it can lead to vascular dementia in the long-term.”

No funding was declared. Kotecha declares relationships with Bayer, Protherics Medicines Development, Boston Scientific, Daiichi Sankyo, Boehringer Ingelheim, BMS-Pfizer Alliance, Amomed, MyoKardia. Curtis declared relationships with Janssen Pharmaceuticals, Medtronic, Abbott. Joglar declared no relevant relationships. Tedrow declared no relevant relationships.

A version of this article appeared on Medscape.com.

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Periodontitis Management: GPs Should Play a Role

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Periodontitis is a chronic inflammatory disease that triggers a local immuno-inflammatory response, potentially leading to periodontal tissue destruction and tooth loss. Affecting 1.1 billion people worldwide, periodontitis is recognized as a significant public health issue. It is also linked to a number of other conditions, such as diabetes, cardiovascular disease, and respiratory disorders. The European Federation of Periodontology recently published a consensus report recommending that the optimal management of periodontitis should involve a collaboration between general practitioners (GPs) and oral health professionals.

Diabetes and Periodontitis

A bidirectional association exists between diabetes and periodontitis. Hyperglycemia accelerates periodontitis progression by promoting inflammation and hindering the healing process, while periodontitis is associated with higher hemoglobin A1c levels in patients with diabetes and an increased risk for diabetes development in others. Intervention studies have demonstrated the positive effect of glycemic control on periodontitis and vice versa, with periodontal treatment improving A1c levels.

GPs can raise awareness of the links between these conditions as well as emphasize the benefits of addressing both metabolic and periodontal abnormalities. They should refer patients with diabetes to oral health specialists and look for signs of periodontitis, such as bleeding gums and loose teeth, in patients with diabetes and those with prediabetes.

 

Cardiovascular Diseases and Periodontitis

Cardiovascular diseases and periodontitis are linked by their epidemiological associations and common biologic mechanisms. This connection can be explained by some of their shared risk factors, such as smoking and systemic inflammatory pathways. Although no intervention studies have shown a direct reduction in cardiovascular risk from periodontal care, two studies have demonstrated improvements in surrogate markers such as blood pressure and arterial stiffness. GPs should inquire about symptoms of periodontitis in cardiovascular patients and, if necessary, refer them to oral health specialists. Periodontal treatments, whether surgical or nonsurgical, pose no risk for patients receiving well-managed secondary preventive treatments.

 

Respiratory Diseases and Periodontitis

The primary evidence linking periodontitis with chronic respiratory diseases concerns chronic obstructive pulmonary disease (COPD). Individuals with periodontitis have a 33% higher risk of developing COPD, and patients with COPD and periodontitis may experience a greater decline in lung function. An established association also exists between periodontitis and obstructive sleep apnea, although the data remain inconclusive regarding a link with asthma. GPs should encourage patients with COPD to quit smoking, as it benefits both respiratory and oral health.

Finally, based on meta-analyses of COVID-19, experts note significant associations between periodontitis and the need for assisted ventilation or the risk for death during a COVID-19 infection.

This story was translated from Univadis France using several editorial tools, including AI, as part of the process. Human editors reviewed this content before publication. A version of this article appeared on Medscape.com.

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Periodontitis is a chronic inflammatory disease that triggers a local immuno-inflammatory response, potentially leading to periodontal tissue destruction and tooth loss. Affecting 1.1 billion people worldwide, periodontitis is recognized as a significant public health issue. It is also linked to a number of other conditions, such as diabetes, cardiovascular disease, and respiratory disorders. The European Federation of Periodontology recently published a consensus report recommending that the optimal management of periodontitis should involve a collaboration between general practitioners (GPs) and oral health professionals.

Diabetes and Periodontitis

A bidirectional association exists between diabetes and periodontitis. Hyperglycemia accelerates periodontitis progression by promoting inflammation and hindering the healing process, while periodontitis is associated with higher hemoglobin A1c levels in patients with diabetes and an increased risk for diabetes development in others. Intervention studies have demonstrated the positive effect of glycemic control on periodontitis and vice versa, with periodontal treatment improving A1c levels.

GPs can raise awareness of the links between these conditions as well as emphasize the benefits of addressing both metabolic and periodontal abnormalities. They should refer patients with diabetes to oral health specialists and look for signs of periodontitis, such as bleeding gums and loose teeth, in patients with diabetes and those with prediabetes.

 

Cardiovascular Diseases and Periodontitis

Cardiovascular diseases and periodontitis are linked by their epidemiological associations and common biologic mechanisms. This connection can be explained by some of their shared risk factors, such as smoking and systemic inflammatory pathways. Although no intervention studies have shown a direct reduction in cardiovascular risk from periodontal care, two studies have demonstrated improvements in surrogate markers such as blood pressure and arterial stiffness. GPs should inquire about symptoms of periodontitis in cardiovascular patients and, if necessary, refer them to oral health specialists. Periodontal treatments, whether surgical or nonsurgical, pose no risk for patients receiving well-managed secondary preventive treatments.

 

Respiratory Diseases and Periodontitis

The primary evidence linking periodontitis with chronic respiratory diseases concerns chronic obstructive pulmonary disease (COPD). Individuals with periodontitis have a 33% higher risk of developing COPD, and patients with COPD and periodontitis may experience a greater decline in lung function. An established association also exists between periodontitis and obstructive sleep apnea, although the data remain inconclusive regarding a link with asthma. GPs should encourage patients with COPD to quit smoking, as it benefits both respiratory and oral health.

Finally, based on meta-analyses of COVID-19, experts note significant associations between periodontitis and the need for assisted ventilation or the risk for death during a COVID-19 infection.

This story was translated from Univadis France using several editorial tools, including AI, as part of the process. Human editors reviewed this content before publication. A version of this article appeared on Medscape.com.

Periodontitis is a chronic inflammatory disease that triggers a local immuno-inflammatory response, potentially leading to periodontal tissue destruction and tooth loss. Affecting 1.1 billion people worldwide, periodontitis is recognized as a significant public health issue. It is also linked to a number of other conditions, such as diabetes, cardiovascular disease, and respiratory disorders. The European Federation of Periodontology recently published a consensus report recommending that the optimal management of periodontitis should involve a collaboration between general practitioners (GPs) and oral health professionals.

Diabetes and Periodontitis

A bidirectional association exists between diabetes and periodontitis. Hyperglycemia accelerates periodontitis progression by promoting inflammation and hindering the healing process, while periodontitis is associated with higher hemoglobin A1c levels in patients with diabetes and an increased risk for diabetes development in others. Intervention studies have demonstrated the positive effect of glycemic control on periodontitis and vice versa, with periodontal treatment improving A1c levels.

GPs can raise awareness of the links between these conditions as well as emphasize the benefits of addressing both metabolic and periodontal abnormalities. They should refer patients with diabetes to oral health specialists and look for signs of periodontitis, such as bleeding gums and loose teeth, in patients with diabetes and those with prediabetes.

 

Cardiovascular Diseases and Periodontitis

Cardiovascular diseases and periodontitis are linked by their epidemiological associations and common biologic mechanisms. This connection can be explained by some of their shared risk factors, such as smoking and systemic inflammatory pathways. Although no intervention studies have shown a direct reduction in cardiovascular risk from periodontal care, two studies have demonstrated improvements in surrogate markers such as blood pressure and arterial stiffness. GPs should inquire about symptoms of periodontitis in cardiovascular patients and, if necessary, refer them to oral health specialists. Periodontal treatments, whether surgical or nonsurgical, pose no risk for patients receiving well-managed secondary preventive treatments.

 

Respiratory Diseases and Periodontitis

The primary evidence linking periodontitis with chronic respiratory diseases concerns chronic obstructive pulmonary disease (COPD). Individuals with periodontitis have a 33% higher risk of developing COPD, and patients with COPD and periodontitis may experience a greater decline in lung function. An established association also exists between periodontitis and obstructive sleep apnea, although the data remain inconclusive regarding a link with asthma. GPs should encourage patients with COPD to quit smoking, as it benefits both respiratory and oral health.

Finally, based on meta-analyses of COVID-19, experts note significant associations between periodontitis and the need for assisted ventilation or the risk for death during a COVID-19 infection.

This story was translated from Univadis France using several editorial tools, including AI, as part of the process. Human editors reviewed this content before publication. A version of this article appeared on Medscape.com.

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Hemorrhoidal Disease Management: When and How to Intervene

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For patients with edematous hemorrhoidal thrombosis, the first line of treatment is a nonsteroidal anti-inflammatory drug (NSAID) such as ketoprofen, in conjunction with an analgesic, according to Vincent de Parades, MD, PhD, of Hôpital Paris Saint-Joseph in France. In his presentation at France’s annual general medicine conference (JNMG 2024) on the management of hemorrhoidal disease, he noted, “this [NSAID and analgesic] treatment is highly effective, initially relieving pain and reducing edema, though the clot takes longer to resolve.” In cases where residual skin tags (marisques) remain after an episode, resection may be considered if they cause discomfort.

While patients often turn to over-the-counter topical treatments during flare-ups, de Parades noted that these have not been proven effective for hemorrhoidal disease. For hemorrhoidal thrombosis, however, a topical treatment with a corticosteroid and anesthetic may be prescribed.

 

No NSAIDs for Abscesses

In addition to NSAIDs, a local treatment may provide soothing benefits, especially when combined with topical application, as highlighted by Nadia Fathallah, MD, of Hôpital Paris Saint-Joseph, who joined de Parades in the presentation. “I recommend massaging the ointment to help dissolve the thrombus,” she added. However, “NSAIDs should not be prescribed in the case of an abscess,” cautioned de Parades, emphasizing that “any patient with a painful anal swelling needs an examination.” When in doubt, administer an analgesic and reexamine the patient 1-2 days later. If an abscess is present, it will not resolve on its own, and pain will persist.

The two proctologists reviewed various interventions for managing hemorrhoidal conditions, underscoring the benefits of minimally invasive surgery as an alternative to hemorrhoidectomy for treating grade 2 or 3 hemorrhoidal prolapse.

Hemorrhoidal disease involves abnormal dilation of the vascular system in the anus and rectum. External hemorrhoids affect the external vascular plexus, while internal hemorrhoids occur in the upper part of the anal canal at the internal plexus.

 

Hygiene and Dietary Guidelines

Common symptoms include light to heavy bleeding during bowel movements and the sensation of a lump inside the anus. In some cases, this is accompanied by throbbing pain, which suggests hemorrhoidal thrombosis, a condition often associated with a painful external swelling. Hemorrhoidal prolapse, meanwhile, is characterized by the protrusion of internal hemorrhoids and is classified into four grades:

  • Grade 1: Hemorrhoids emerge during straining but do not protrude externally.
  • Grade 2: Hemorrhoids protrude but spontaneously retract after straining.
  • Grade 3: Hemorrhoids protrude with straining and require manual reinsertion.
  • Grade 4: Prolapse is permanent.

In all cases, medical treatment is recommended as the initial approach. European guidelines recommend to first implement lifestyle and dietary measures, encouraging regular physical activity and adequate water and fiber intake to promote intestinal transit. Laxatives may also be recommended.

 

Elastic Band Ligation

For hemorrhoidal thrombosis, NSAIDs and nonopioid analgesics are recommended as first-line treatments. For patients with contraindications to NSAIDs, such as pregnant women, corticosteroid treatment may be administered, although it is less effective. Routine incision is no longer recommended, according to de Parades.

For prolapsed internal hemorrhoids, instrumental treatment is recommended as a second-line option if medical management fails for grades 1 and 2, or for isolated grade 3 hemorrhoids. With sclerotherapy injections largely phased out, two options remain: Infrared photocoagulation and elastic band ligation.

The objective of instrumental treatment is to create a scar at the top of the hemorrhoidal plexus to reduce vascularization and secure the hemorrhoid to the rectal wall. When correctly performed above the insensitive mucosal area in the anal canal, the procedure is painless.

Ligation involves placing an elastic band at the base of the hemorrhoid, with the intervention taking only a few minutes. “Within 4 weeks, the hemorrhoid disappears,” explained de Parades. Photocoagulation is a more superficial treatment requiring several spaced sessions, mainly to address bleeding.

 

Advances in Minimally Invasive Surgery

Surgery is recommended if instrumental treatment fails and as a first-line option for circular grade 3 hemorrhoids (multiple hemorrhoidal masses) and grade 4 cases.

Milligan-Morgan hemorrhoidectomy is considered the “gold standard” surgical technique and is used primarily for grades 2, 3, and 4 cases. This technique involves resecting the three main hemorrhoidal bundles while preserving surrounding tissue, providing a “radical and definitive” treatment.

While effective in the long term, hemorrhoid bundle resection requires a lengthy healing process and typically requires the patient to take 15-20 days off work. It is also not recommended for people who engage in anal intercourse, as “removing hemorrhoidal tissue can reduce flexibility and sensation in the anal canal,” Fathallah noted.

Another widely used technique in France is Doppler-guided hemorrhoidal artery ligation, which selectively reduces blood flow to the hemorrhoidal plexus. It is often combined with a mucopexy to secure the prolapse above the anal canal and restore normal anatomy.

Minimally invasive surgery is today increasingly considered an alternative to hemorrhoidectomy for treating grade 2 or 3 hemorrhoidal prolapse.

Laser and radiofrequency techniques induce submucosal coagulation, reducing arterial flow and creating fibrous tissue to retract the hemorrhoidal bundle. Because the procedure is applied above the anal canal, “it is associated with little or no pain.”

 

Hemorrhoidal Embolization

Recent studies have validated the benefits of minimally invasive surgery for this condition. In a French multicenter study, radiofrequency treatment significantly improved quality of life 3 months post operation, requiring only 4 days off work. The vast majority of patients said they were satisfied with the results.

The procedure is less uncomfortable than hemorrhoidectomy and allows for quicker recovery, but it carries a risk for recurrence. In the French study, nearly 8% of patients required reoperation within a year, mostly by hemorrhoidectomy. “The estimated recurrence rate is 20%-30% over 10 years,” said de Parades.

Overall, the specialist emphasized the value of surgery, including hemorrhoidectomy, in treating hemorrhoidal prolapse. With substantial benefits from minimally invasive options, “patients should be referred early” to prevent prolapse progression “that might leave no choice but hemorrhoidectomy.”

Finally, another technique is available for bleeding without prolapse: Hemorrhoidal embolization. Practiced for about a decade, the procedure involves blocking blood flow to the hemorrhoids by inserting tiny metal coils through a catheter, which is inserted via a transcutaneous route through an artery in the arm.

This story was translated from Medscape’s French edition using several editorial tools, including AI, as part of the process. Human editors reviewed this content before publication. A version appeared on Medscape.com.

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For patients with edematous hemorrhoidal thrombosis, the first line of treatment is a nonsteroidal anti-inflammatory drug (NSAID) such as ketoprofen, in conjunction with an analgesic, according to Vincent de Parades, MD, PhD, of Hôpital Paris Saint-Joseph in France. In his presentation at France’s annual general medicine conference (JNMG 2024) on the management of hemorrhoidal disease, he noted, “this [NSAID and analgesic] treatment is highly effective, initially relieving pain and reducing edema, though the clot takes longer to resolve.” In cases where residual skin tags (marisques) remain after an episode, resection may be considered if they cause discomfort.

While patients often turn to over-the-counter topical treatments during flare-ups, de Parades noted that these have not been proven effective for hemorrhoidal disease. For hemorrhoidal thrombosis, however, a topical treatment with a corticosteroid and anesthetic may be prescribed.

 

No NSAIDs for Abscesses

In addition to NSAIDs, a local treatment may provide soothing benefits, especially when combined with topical application, as highlighted by Nadia Fathallah, MD, of Hôpital Paris Saint-Joseph, who joined de Parades in the presentation. “I recommend massaging the ointment to help dissolve the thrombus,” she added. However, “NSAIDs should not be prescribed in the case of an abscess,” cautioned de Parades, emphasizing that “any patient with a painful anal swelling needs an examination.” When in doubt, administer an analgesic and reexamine the patient 1-2 days later. If an abscess is present, it will not resolve on its own, and pain will persist.

The two proctologists reviewed various interventions for managing hemorrhoidal conditions, underscoring the benefits of minimally invasive surgery as an alternative to hemorrhoidectomy for treating grade 2 or 3 hemorrhoidal prolapse.

Hemorrhoidal disease involves abnormal dilation of the vascular system in the anus and rectum. External hemorrhoids affect the external vascular plexus, while internal hemorrhoids occur in the upper part of the anal canal at the internal plexus.

 

Hygiene and Dietary Guidelines

Common symptoms include light to heavy bleeding during bowel movements and the sensation of a lump inside the anus. In some cases, this is accompanied by throbbing pain, which suggests hemorrhoidal thrombosis, a condition often associated with a painful external swelling. Hemorrhoidal prolapse, meanwhile, is characterized by the protrusion of internal hemorrhoids and is classified into four grades:

  • Grade 1: Hemorrhoids emerge during straining but do not protrude externally.
  • Grade 2: Hemorrhoids protrude but spontaneously retract after straining.
  • Grade 3: Hemorrhoids protrude with straining and require manual reinsertion.
  • Grade 4: Prolapse is permanent.

In all cases, medical treatment is recommended as the initial approach. European guidelines recommend to first implement lifestyle and dietary measures, encouraging regular physical activity and adequate water and fiber intake to promote intestinal transit. Laxatives may also be recommended.

 

Elastic Band Ligation

For hemorrhoidal thrombosis, NSAIDs and nonopioid analgesics are recommended as first-line treatments. For patients with contraindications to NSAIDs, such as pregnant women, corticosteroid treatment may be administered, although it is less effective. Routine incision is no longer recommended, according to de Parades.

For prolapsed internal hemorrhoids, instrumental treatment is recommended as a second-line option if medical management fails for grades 1 and 2, or for isolated grade 3 hemorrhoids. With sclerotherapy injections largely phased out, two options remain: Infrared photocoagulation and elastic band ligation.

The objective of instrumental treatment is to create a scar at the top of the hemorrhoidal plexus to reduce vascularization and secure the hemorrhoid to the rectal wall. When correctly performed above the insensitive mucosal area in the anal canal, the procedure is painless.

Ligation involves placing an elastic band at the base of the hemorrhoid, with the intervention taking only a few minutes. “Within 4 weeks, the hemorrhoid disappears,” explained de Parades. Photocoagulation is a more superficial treatment requiring several spaced sessions, mainly to address bleeding.

 

Advances in Minimally Invasive Surgery

Surgery is recommended if instrumental treatment fails and as a first-line option for circular grade 3 hemorrhoids (multiple hemorrhoidal masses) and grade 4 cases.

Milligan-Morgan hemorrhoidectomy is considered the “gold standard” surgical technique and is used primarily for grades 2, 3, and 4 cases. This technique involves resecting the three main hemorrhoidal bundles while preserving surrounding tissue, providing a “radical and definitive” treatment.

While effective in the long term, hemorrhoid bundle resection requires a lengthy healing process and typically requires the patient to take 15-20 days off work. It is also not recommended for people who engage in anal intercourse, as “removing hemorrhoidal tissue can reduce flexibility and sensation in the anal canal,” Fathallah noted.

Another widely used technique in France is Doppler-guided hemorrhoidal artery ligation, which selectively reduces blood flow to the hemorrhoidal plexus. It is often combined with a mucopexy to secure the prolapse above the anal canal and restore normal anatomy.

Minimally invasive surgery is today increasingly considered an alternative to hemorrhoidectomy for treating grade 2 or 3 hemorrhoidal prolapse.

Laser and radiofrequency techniques induce submucosal coagulation, reducing arterial flow and creating fibrous tissue to retract the hemorrhoidal bundle. Because the procedure is applied above the anal canal, “it is associated with little or no pain.”

 

Hemorrhoidal Embolization

Recent studies have validated the benefits of minimally invasive surgery for this condition. In a French multicenter study, radiofrequency treatment significantly improved quality of life 3 months post operation, requiring only 4 days off work. The vast majority of patients said they were satisfied with the results.

The procedure is less uncomfortable than hemorrhoidectomy and allows for quicker recovery, but it carries a risk for recurrence. In the French study, nearly 8% of patients required reoperation within a year, mostly by hemorrhoidectomy. “The estimated recurrence rate is 20%-30% over 10 years,” said de Parades.

Overall, the specialist emphasized the value of surgery, including hemorrhoidectomy, in treating hemorrhoidal prolapse. With substantial benefits from minimally invasive options, “patients should be referred early” to prevent prolapse progression “that might leave no choice but hemorrhoidectomy.”

Finally, another technique is available for bleeding without prolapse: Hemorrhoidal embolization. Practiced for about a decade, the procedure involves blocking blood flow to the hemorrhoids by inserting tiny metal coils through a catheter, which is inserted via a transcutaneous route through an artery in the arm.

This story was translated from Medscape’s French edition using several editorial tools, including AI, as part of the process. Human editors reviewed this content before publication. A version appeared on Medscape.com.

For patients with edematous hemorrhoidal thrombosis, the first line of treatment is a nonsteroidal anti-inflammatory drug (NSAID) such as ketoprofen, in conjunction with an analgesic, according to Vincent de Parades, MD, PhD, of Hôpital Paris Saint-Joseph in France. In his presentation at France’s annual general medicine conference (JNMG 2024) on the management of hemorrhoidal disease, he noted, “this [NSAID and analgesic] treatment is highly effective, initially relieving pain and reducing edema, though the clot takes longer to resolve.” In cases where residual skin tags (marisques) remain after an episode, resection may be considered if they cause discomfort.

While patients often turn to over-the-counter topical treatments during flare-ups, de Parades noted that these have not been proven effective for hemorrhoidal disease. For hemorrhoidal thrombosis, however, a topical treatment with a corticosteroid and anesthetic may be prescribed.

 

No NSAIDs for Abscesses

In addition to NSAIDs, a local treatment may provide soothing benefits, especially when combined with topical application, as highlighted by Nadia Fathallah, MD, of Hôpital Paris Saint-Joseph, who joined de Parades in the presentation. “I recommend massaging the ointment to help dissolve the thrombus,” she added. However, “NSAIDs should not be prescribed in the case of an abscess,” cautioned de Parades, emphasizing that “any patient with a painful anal swelling needs an examination.” When in doubt, administer an analgesic and reexamine the patient 1-2 days later. If an abscess is present, it will not resolve on its own, and pain will persist.

The two proctologists reviewed various interventions for managing hemorrhoidal conditions, underscoring the benefits of minimally invasive surgery as an alternative to hemorrhoidectomy for treating grade 2 or 3 hemorrhoidal prolapse.

Hemorrhoidal disease involves abnormal dilation of the vascular system in the anus and rectum. External hemorrhoids affect the external vascular plexus, while internal hemorrhoids occur in the upper part of the anal canal at the internal plexus.

 

Hygiene and Dietary Guidelines

Common symptoms include light to heavy bleeding during bowel movements and the sensation of a lump inside the anus. In some cases, this is accompanied by throbbing pain, which suggests hemorrhoidal thrombosis, a condition often associated with a painful external swelling. Hemorrhoidal prolapse, meanwhile, is characterized by the protrusion of internal hemorrhoids and is classified into four grades:

  • Grade 1: Hemorrhoids emerge during straining but do not protrude externally.
  • Grade 2: Hemorrhoids protrude but spontaneously retract after straining.
  • Grade 3: Hemorrhoids protrude with straining and require manual reinsertion.
  • Grade 4: Prolapse is permanent.

In all cases, medical treatment is recommended as the initial approach. European guidelines recommend to first implement lifestyle and dietary measures, encouraging regular physical activity and adequate water and fiber intake to promote intestinal transit. Laxatives may also be recommended.

 

Elastic Band Ligation

For hemorrhoidal thrombosis, NSAIDs and nonopioid analgesics are recommended as first-line treatments. For patients with contraindications to NSAIDs, such as pregnant women, corticosteroid treatment may be administered, although it is less effective. Routine incision is no longer recommended, according to de Parades.

For prolapsed internal hemorrhoids, instrumental treatment is recommended as a second-line option if medical management fails for grades 1 and 2, or for isolated grade 3 hemorrhoids. With sclerotherapy injections largely phased out, two options remain: Infrared photocoagulation and elastic band ligation.

The objective of instrumental treatment is to create a scar at the top of the hemorrhoidal plexus to reduce vascularization and secure the hemorrhoid to the rectal wall. When correctly performed above the insensitive mucosal area in the anal canal, the procedure is painless.

Ligation involves placing an elastic band at the base of the hemorrhoid, with the intervention taking only a few minutes. “Within 4 weeks, the hemorrhoid disappears,” explained de Parades. Photocoagulation is a more superficial treatment requiring several spaced sessions, mainly to address bleeding.

 

Advances in Minimally Invasive Surgery

Surgery is recommended if instrumental treatment fails and as a first-line option for circular grade 3 hemorrhoids (multiple hemorrhoidal masses) and grade 4 cases.

Milligan-Morgan hemorrhoidectomy is considered the “gold standard” surgical technique and is used primarily for grades 2, 3, and 4 cases. This technique involves resecting the three main hemorrhoidal bundles while preserving surrounding tissue, providing a “radical and definitive” treatment.

While effective in the long term, hemorrhoid bundle resection requires a lengthy healing process and typically requires the patient to take 15-20 days off work. It is also not recommended for people who engage in anal intercourse, as “removing hemorrhoidal tissue can reduce flexibility and sensation in the anal canal,” Fathallah noted.

Another widely used technique in France is Doppler-guided hemorrhoidal artery ligation, which selectively reduces blood flow to the hemorrhoidal plexus. It is often combined with a mucopexy to secure the prolapse above the anal canal and restore normal anatomy.

Minimally invasive surgery is today increasingly considered an alternative to hemorrhoidectomy for treating grade 2 or 3 hemorrhoidal prolapse.

Laser and radiofrequency techniques induce submucosal coagulation, reducing arterial flow and creating fibrous tissue to retract the hemorrhoidal bundle. Because the procedure is applied above the anal canal, “it is associated with little or no pain.”

 

Hemorrhoidal Embolization

Recent studies have validated the benefits of minimally invasive surgery for this condition. In a French multicenter study, radiofrequency treatment significantly improved quality of life 3 months post operation, requiring only 4 days off work. The vast majority of patients said they were satisfied with the results.

The procedure is less uncomfortable than hemorrhoidectomy and allows for quicker recovery, but it carries a risk for recurrence. In the French study, nearly 8% of patients required reoperation within a year, mostly by hemorrhoidectomy. “The estimated recurrence rate is 20%-30% over 10 years,” said de Parades.

Overall, the specialist emphasized the value of surgery, including hemorrhoidectomy, in treating hemorrhoidal prolapse. With substantial benefits from minimally invasive options, “patients should be referred early” to prevent prolapse progression “that might leave no choice but hemorrhoidectomy.”

Finally, another technique is available for bleeding without prolapse: Hemorrhoidal embolization. Practiced for about a decade, the procedure involves blocking blood flow to the hemorrhoids by inserting tiny metal coils through a catheter, which is inserted via a transcutaneous route through an artery in the arm.

This story was translated from Medscape’s French edition using several editorial tools, including AI, as part of the process. Human editors reviewed this content before publication. A version appeared on Medscape.com.

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New Cause of Sexually Transmitted Fungal Infection Reported in MSM

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A dermatophyte known as Trichophyton mentagrophytes genotype VII (TMVII) has been identified as the cause of an emerging sexually transmitted fungal infection in four adults in the United States, according to a paper published in the Centers for Disease Control and Prevention’s Morbidity and Mortality Weekly Report.

TMVII is a sexually transmitted fungus that causes genital tinea; the fungus might be misidentified as eczema, psoriasis, or other dermatologic conditions, Jason E. Zucker, MD, an infectious disease specialist at Columbia University Irving Medical Center, New York City, and colleagues wrote.

 

Dr. Avrom S. Caplan

“Dermatophyte infections, including TMVII, are spread through direct skin-to-skin contact,” corresponding author Avrom S. Caplan, MD, a dermatologist at New York University Grossman School of Medicine, New York City, said in an interview.

“In the United States, to our knowledge, the infection has only been in MSM [men who have sex with men], but there have been reports of TMVII in Europe in non-MSM patients, including among patients who traveled to Southeast Asia for sex tourism or partners of people who have been infected with TMVII,” he said.

The four patients were diagnosed with tinea between April 2024 and July 2024, and fungal cultures and DNA sequencing identified TMVII as the cause of the infection. All four patients were cisgender men aged 30-39 years from New York City who reported recent sexual contact with other men; one was a sex worker, two had sex with each other, and one reported recent travel to Europe.

All four patients presented with rashes on the face, buttocks, or genitals; all were successfully treated with antifungals, the authors wrote.

Individuals with genital lesions who are sexually active should be seen by a healthcare provider, and TMVII should be considered, especially in the event of scaly, itchy, or inflamed rashes elsewhere on the body, Caplan told this news organization.

Additionally, “If someone presents for a medical evaluation and has ringworm on the buttocks, face, or elsewhere, especially if they are sexually active, the question of TMVII should arise, and the patient should be asked about possible genital lesions as well,” he said. “Any patient diagnosed with an STI [sexually transmitted infection], including MSM patients, should be evaluated appropriately for other STIs including TMVII.” 

Continued surveillance and monitoring are needed to track TMVII and to better understand emerging infections, Caplan told this news organization. Clinicians can find more information and a dermatophyte registry via the American Academy of Dermatology websites on emerging diseases in general and dermatophytes in particular.

“We also need better access to testing and more rapid confirmatory testing to detect emerging dermatophyte strains and monitor antifungal resistance patterns,” Caplan added. “At this time, we do not have evidence to suggest there is antifungal resistance in TMVII, which also distinguishes it from T indotineae.” 

 

Encourage Reporting and Identify New Infections

“Emerging infections can mimic noninfectious disease processes, which can make the diagnosis challenging,” Shirin A. Mazumder, MD, associate professor and infectious disease specialist at the University of Tennessee Health Science Center, Memphis, said in an interview.

“Monitoring emerging infections can be difficult if the cases are not reported and if the disease is not widespread,” Mazumder noted. Educating clinicians with case reports and encouraging them to report unusual cases to public health helps to overcome this challenge.

In the clinical setting, skin lesions that fail to respond or worsen with the application of topical steroids could be a red flag for TMVII, Mazumder told this news organization. “Since the skin findings of TMVII can closely resemble noninfectious processes such as eczema or psoriasis, the use of topical corticosteroids may have already been tried before the diagnosis of TMVII is considered.” 

Also, location matters in making the diagnosis. TMVII lesions occur on the face, genitals, extremities, trunk, and buttocks. Obtaining a thorough sexual history is important because the fungus spreads from close contact through sexual exposure, Mazumder added.

The most effective treatment for TMVII infections remains to be determined, Mazumder said. “Treatment considerations such as combination treatment with oral and topical antifungal medications vs oral antifungal medication alone is something that needs further research along with the best treatment duration.”

“Determining the rate of transmissibility between contacts, when someone is considered to be the most infectious, how long someone is considered infectious once infected, and rates of reinfection are questions that may benefit from further study,” she added.

Although the current cases are reported in MSM, determining how TMVII affects other patient populations will be interesting as more cases are reported, said Mazumder. “Further understanding of how different degrees of immunosuppression affect TMVII disease course is another important consideration.” 

Finally, determining the rate of long-term sequelae from TMVII infection and the rate of bacterial co-infection will help better understand TMVII, she said.

The researchers had no financial conflicts to disclose. Mazumder had no financial conflicts to disclose.

A version of this article first appeared on Medscape.com.

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A dermatophyte known as Trichophyton mentagrophytes genotype VII (TMVII) has been identified as the cause of an emerging sexually transmitted fungal infection in four adults in the United States, according to a paper published in the Centers for Disease Control and Prevention’s Morbidity and Mortality Weekly Report.

TMVII is a sexually transmitted fungus that causes genital tinea; the fungus might be misidentified as eczema, psoriasis, or other dermatologic conditions, Jason E. Zucker, MD, an infectious disease specialist at Columbia University Irving Medical Center, New York City, and colleagues wrote.

 

Dr. Avrom S. Caplan

“Dermatophyte infections, including TMVII, are spread through direct skin-to-skin contact,” corresponding author Avrom S. Caplan, MD, a dermatologist at New York University Grossman School of Medicine, New York City, said in an interview.

“In the United States, to our knowledge, the infection has only been in MSM [men who have sex with men], but there have been reports of TMVII in Europe in non-MSM patients, including among patients who traveled to Southeast Asia for sex tourism or partners of people who have been infected with TMVII,” he said.

The four patients were diagnosed with tinea between April 2024 and July 2024, and fungal cultures and DNA sequencing identified TMVII as the cause of the infection. All four patients were cisgender men aged 30-39 years from New York City who reported recent sexual contact with other men; one was a sex worker, two had sex with each other, and one reported recent travel to Europe.

All four patients presented with rashes on the face, buttocks, or genitals; all were successfully treated with antifungals, the authors wrote.

Individuals with genital lesions who are sexually active should be seen by a healthcare provider, and TMVII should be considered, especially in the event of scaly, itchy, or inflamed rashes elsewhere on the body, Caplan told this news organization.

Additionally, “If someone presents for a medical evaluation and has ringworm on the buttocks, face, or elsewhere, especially if they are sexually active, the question of TMVII should arise, and the patient should be asked about possible genital lesions as well,” he said. “Any patient diagnosed with an STI [sexually transmitted infection], including MSM patients, should be evaluated appropriately for other STIs including TMVII.” 

Continued surveillance and monitoring are needed to track TMVII and to better understand emerging infections, Caplan told this news organization. Clinicians can find more information and a dermatophyte registry via the American Academy of Dermatology websites on emerging diseases in general and dermatophytes in particular.

“We also need better access to testing and more rapid confirmatory testing to detect emerging dermatophyte strains and monitor antifungal resistance patterns,” Caplan added. “At this time, we do not have evidence to suggest there is antifungal resistance in TMVII, which also distinguishes it from T indotineae.” 

 

Encourage Reporting and Identify New Infections

“Emerging infections can mimic noninfectious disease processes, which can make the diagnosis challenging,” Shirin A. Mazumder, MD, associate professor and infectious disease specialist at the University of Tennessee Health Science Center, Memphis, said in an interview.

“Monitoring emerging infections can be difficult if the cases are not reported and if the disease is not widespread,” Mazumder noted. Educating clinicians with case reports and encouraging them to report unusual cases to public health helps to overcome this challenge.

In the clinical setting, skin lesions that fail to respond or worsen with the application of topical steroids could be a red flag for TMVII, Mazumder told this news organization. “Since the skin findings of TMVII can closely resemble noninfectious processes such as eczema or psoriasis, the use of topical corticosteroids may have already been tried before the diagnosis of TMVII is considered.” 

Also, location matters in making the diagnosis. TMVII lesions occur on the face, genitals, extremities, trunk, and buttocks. Obtaining a thorough sexual history is important because the fungus spreads from close contact through sexual exposure, Mazumder added.

The most effective treatment for TMVII infections remains to be determined, Mazumder said. “Treatment considerations such as combination treatment with oral and topical antifungal medications vs oral antifungal medication alone is something that needs further research along with the best treatment duration.”

“Determining the rate of transmissibility between contacts, when someone is considered to be the most infectious, how long someone is considered infectious once infected, and rates of reinfection are questions that may benefit from further study,” she added.

Although the current cases are reported in MSM, determining how TMVII affects other patient populations will be interesting as more cases are reported, said Mazumder. “Further understanding of how different degrees of immunosuppression affect TMVII disease course is another important consideration.” 

Finally, determining the rate of long-term sequelae from TMVII infection and the rate of bacterial co-infection will help better understand TMVII, she said.

The researchers had no financial conflicts to disclose. Mazumder had no financial conflicts to disclose.

A version of this article first appeared on Medscape.com.

A dermatophyte known as Trichophyton mentagrophytes genotype VII (TMVII) has been identified as the cause of an emerging sexually transmitted fungal infection in four adults in the United States, according to a paper published in the Centers for Disease Control and Prevention’s Morbidity and Mortality Weekly Report.

TMVII is a sexually transmitted fungus that causes genital tinea; the fungus might be misidentified as eczema, psoriasis, or other dermatologic conditions, Jason E. Zucker, MD, an infectious disease specialist at Columbia University Irving Medical Center, New York City, and colleagues wrote.

 

Dr. Avrom S. Caplan

“Dermatophyte infections, including TMVII, are spread through direct skin-to-skin contact,” corresponding author Avrom S. Caplan, MD, a dermatologist at New York University Grossman School of Medicine, New York City, said in an interview.

“In the United States, to our knowledge, the infection has only been in MSM [men who have sex with men], but there have been reports of TMVII in Europe in non-MSM patients, including among patients who traveled to Southeast Asia for sex tourism or partners of people who have been infected with TMVII,” he said.

The four patients were diagnosed with tinea between April 2024 and July 2024, and fungal cultures and DNA sequencing identified TMVII as the cause of the infection. All four patients were cisgender men aged 30-39 years from New York City who reported recent sexual contact with other men; one was a sex worker, two had sex with each other, and one reported recent travel to Europe.

All four patients presented with rashes on the face, buttocks, or genitals; all were successfully treated with antifungals, the authors wrote.

Individuals with genital lesions who are sexually active should be seen by a healthcare provider, and TMVII should be considered, especially in the event of scaly, itchy, or inflamed rashes elsewhere on the body, Caplan told this news organization.

Additionally, “If someone presents for a medical evaluation and has ringworm on the buttocks, face, or elsewhere, especially if they are sexually active, the question of TMVII should arise, and the patient should be asked about possible genital lesions as well,” he said. “Any patient diagnosed with an STI [sexually transmitted infection], including MSM patients, should be evaluated appropriately for other STIs including TMVII.” 

Continued surveillance and monitoring are needed to track TMVII and to better understand emerging infections, Caplan told this news organization. Clinicians can find more information and a dermatophyte registry via the American Academy of Dermatology websites on emerging diseases in general and dermatophytes in particular.

“We also need better access to testing and more rapid confirmatory testing to detect emerging dermatophyte strains and monitor antifungal resistance patterns,” Caplan added. “At this time, we do not have evidence to suggest there is antifungal resistance in TMVII, which also distinguishes it from T indotineae.” 

 

Encourage Reporting and Identify New Infections

“Emerging infections can mimic noninfectious disease processes, which can make the diagnosis challenging,” Shirin A. Mazumder, MD, associate professor and infectious disease specialist at the University of Tennessee Health Science Center, Memphis, said in an interview.

“Monitoring emerging infections can be difficult if the cases are not reported and if the disease is not widespread,” Mazumder noted. Educating clinicians with case reports and encouraging them to report unusual cases to public health helps to overcome this challenge.

In the clinical setting, skin lesions that fail to respond or worsen with the application of topical steroids could be a red flag for TMVII, Mazumder told this news organization. “Since the skin findings of TMVII can closely resemble noninfectious processes such as eczema or psoriasis, the use of topical corticosteroids may have already been tried before the diagnosis of TMVII is considered.” 

Also, location matters in making the diagnosis. TMVII lesions occur on the face, genitals, extremities, trunk, and buttocks. Obtaining a thorough sexual history is important because the fungus spreads from close contact through sexual exposure, Mazumder added.

The most effective treatment for TMVII infections remains to be determined, Mazumder said. “Treatment considerations such as combination treatment with oral and topical antifungal medications vs oral antifungal medication alone is something that needs further research along with the best treatment duration.”

“Determining the rate of transmissibility between contacts, when someone is considered to be the most infectious, how long someone is considered infectious once infected, and rates of reinfection are questions that may benefit from further study,” she added.

Although the current cases are reported in MSM, determining how TMVII affects other patient populations will be interesting as more cases are reported, said Mazumder. “Further understanding of how different degrees of immunosuppression affect TMVII disease course is another important consideration.” 

Finally, determining the rate of long-term sequelae from TMVII infection and the rate of bacterial co-infection will help better understand TMVII, she said.

The researchers had no financial conflicts to disclose. Mazumder had no financial conflicts to disclose.

A version of this article first appeared on Medscape.com.

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Survey Study Shows How to Reduce Family Physician Burnout

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Family physician burnout rates are among the highest in medicine. More than half (51%) reported burnout in a Medscape report from January 2024; only emergency physicians (63%) and obstetricians/gynecologists and oncologists (both 53%) had higher rates.

In a recent study, researchers examined what’s driving the burnout through a serial cross-sectional survey of family physicians. Authors conclude that reducing burnout may be most effective with a focus on two factors: Decreasing time spent at home on electronic health record (EHR) tasks and building stronger nurse-physician teams.

Findings by Lisa S. Rotenstein, MD, MBA, MSc, Division of Clinical Informatics, Department of Medicine, University of California, San Francisco, and colleagues were published in JAMA Network Open. The findings debunk some longstanding assumptions, Christine A. Sinsky, MD, vice president of professional satisfaction with the American Medical Association, wrote in an editorial.

“This study advances our understanding that addressing physician burnout is not about more EHR training and not specifically about moving to paying for value; rather, it is about developing stronger nurse-physician core teams. These are novel and important findings with actionable lessons for physician and health system leaders,” Sinsky wrote.
 

More Than 10,000 Physicians; 100% Response Rate

The study included 10,315 physicians who answered questions related to burnout on the American Board of Family Medicine’s Continuous Certification Questionnaire between 2017 and 2023. Researchers achieved a 100% response rate by requiring diplomates to complete the survey before submitting their exam.

The median age of respondents was 50 years. More than half (57.8%) were employees, 11.3% were full owners of their practices, and 3.2% were contractors. Responses indicated that 10% practiced as solo physicians, 20.4% were in a practice with more than 20 physicians, and the rest were in a practice with 2-19 physicians. More than three fourths of the physicians practiced in an urban/suburban setting, and 13.5% practiced in a rural setting.

Physicians’ perceptions that EHR use at home was appropriate were associated with 0.58 times the odds of burnout (95% CI, 0.53-0.64; P < .001), and high team efficiency was associated with 0.61 times the odds of burnout (95% CI, 0.56-0.67).

Physician collaboration with a registered nurse was associated with greater odds of high team efficiency (odds ratio [OR], 1.35; 95% CI, 1.22-1.50). Collaboration with a physician assistant was associated with greater odds of appropriate home EHR time (OR, 1.13; 95% CI, 1.03-1.24).
 

Numbers Needed to Treat

“When translated to a number needed to treat, these ORs suggest that eight additional physicians perceiving appropriate home EHR time would result in prevention of one additional case of burnout, and nine additional physicians perceiving high team efficiency would result in prevention of one case of burnout,” the authors wrote.

The authors also noted that EHR proficiency was not associated with burnout (OR, 0.93; 95% CI, 0.85-1.02; P = .12). Self-reported EHR proficiency remained high and steady over the study period.

“It is time to lay to rest the myth of the technology-resistant physician,” Sinsky wrote in the editorial. “The problem is not the end user.”

Sinsky said the findings also show that value-based compensation “is not a panacea” and, in fact, participation in such payment programs was associated with both more time working on the EHR at home and lower team efficiency.

Fee-for-service models are often painted as the culprit, she noted.

“The key in either compensation model is to direct sufficient financial resources to primary care to cover the costs of optimal team size, skill level, and stability. In my experience, this is a minimum of two clinical assistants (including at least one nurse) per 1.0 clinical full-time equivalent physician, with the same team of individuals working together on a daily basis to develop trust, reliance, and efficiencies.”
 

 

 

Medical Assistants (MAs) Replacing Nurses on Core Teams

In many cases, nurses have been replaced on core clinical teams by MAs, who, with a narrower scope of practice, put work back on the physician’s plate, Sinsky noted, and the MAs also often work in pools rather than with one physician.

“The result is that nurses in many settings are sequestered in a room with a computer and a telephone, with limited direct interactions with their patients or physicians, and physicians spend more time each day on tasks that do not require their medical training,” Sinsky wrote.

Strengths of the study include the large sample size, a 100% response rate to the survey, and consistency of findings over the 6 years.

Steven Waldren, MD, MS, chief medical informatics officer for the American Academy of Family Physicians, said the results of the study confirm what the organization knows to be true through various analyses and talks with doctors: “Even if you can just focus on documentation and improve that, it gives docs hope that other things can happen and actually improve. We saw a decrease in burnout in just solving that one problem.”

Team-based care also allows physicians to talk through challenges and off-load tasks, which allows them to focus on patient care, he said.

Waldren added that some technology upgrades can help reduce burnout without adding staff. He pointed to promising technology in managing EHR inbox messages and in artificial intelligence (AI) solutions for developing a visit summary and patient instructions that can then be reviewed by a physician.

He gave an example of ambient documentation. “We’ve seen that it reduces the amount of documentation time by 60%-70%,” he said. The products in this space record the physician-patient conversation and generate a summary to be reviewed by the physician for accuracy.

“These tools now are highly accurate,” he said. They are also able to remove clinically irrelevant details. He said, for example, if a patient talks about her recent golf outing on a trip to Ireland, the program will record only that she recently had an international trip to Ireland and remove the golf details. The technology has been available for many months, he said.

Sonia Rivera-Martinez, DO, an associate professor of family medicine at the New York Institute of Technology College of Osteopathic Medicine in Old Westbury, New York, said AI solutions are impressive but expensive, which is why her practice has not upgraded to AI-generated visit summaries.

She said even in her academic setting where there is less pressure to see several patients per hour, after-hours EHR work is a reality for her and her colleagues as seeing patients is paired with the demands of teaching students. Her practice is also part of an accountable care organization, which adds its own set of documentation demands.
 

Nearly 30 Hours a Week of EHR Work at Home

Rivera-Martinez estimated that she spends 20-30 hours each week doing EHR tasks at home and said the study authors have highlighted an important problem.

She said she has also seen the value of strong nurse-physician teams in her practice. The two nurses in her practice, for instance, know they have permission to administer flu shots and do other routine tasks without the physicians having to place the order. “But I can’t say it eliminates having to do work outside (of work hours).”

She said before current EHR documentation demands, “I used to be able to finish a progress note in less than 5 minutes.” Now, she said, with her medically complex patient population, it takes her 20-30 minutes to complete a patient’s progress note.

The findings of the study have particular significance with the rising prevalence of burnout among family physicians, the authors wrote. “Clinical leaders and policymakers seeking to develop care delivery models that enable sustainable primary care practice should focus on ensuring adequate team support and acceptable EHR workloads for physicians.”

This study was funded by the United States Office of the National Coordinator for Health Information Technology and Department of Health and Human Services. Additionally, Rotenstein’s time was funded by The Physicians Foundation. Rotenstein reported personal fees from Phreesia; stock grants from serving on the advisory board of Augmedix; and grants from the Agency for Healthcare Research and Quality, American Medical Association, The Physicians Foundation, and Association of Chiefs and Leaders of General Internal Medicine outside the submitted work. Nathaniel Hendrix reported grants from the Office of the National Coordinator for Health Information Technology during the conduct of the study. One coauthor reported a cooperative agreement from the Office of the National Coordinator for Health Information Technology (now Assistant Secretary for Technology Policy/Office of the National Coordinator for Health Information Technology). Another coauthor reported that the University of California, San Francisco, has received funding from the Office of the National Coordinator for Health Information Technology to partner with the American Board of Family Medicine to revise the survey over time to better capture interoperability. Sinsky, Rivera-Martinez, and Waldren reported no relevant financial relationships.

A version of this article first appeared on Medscape.com.

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Family physician burnout rates are among the highest in medicine. More than half (51%) reported burnout in a Medscape report from January 2024; only emergency physicians (63%) and obstetricians/gynecologists and oncologists (both 53%) had higher rates.

In a recent study, researchers examined what’s driving the burnout through a serial cross-sectional survey of family physicians. Authors conclude that reducing burnout may be most effective with a focus on two factors: Decreasing time spent at home on electronic health record (EHR) tasks and building stronger nurse-physician teams.

Findings by Lisa S. Rotenstein, MD, MBA, MSc, Division of Clinical Informatics, Department of Medicine, University of California, San Francisco, and colleagues were published in JAMA Network Open. The findings debunk some longstanding assumptions, Christine A. Sinsky, MD, vice president of professional satisfaction with the American Medical Association, wrote in an editorial.

“This study advances our understanding that addressing physician burnout is not about more EHR training and not specifically about moving to paying for value; rather, it is about developing stronger nurse-physician core teams. These are novel and important findings with actionable lessons for physician and health system leaders,” Sinsky wrote.
 

More Than 10,000 Physicians; 100% Response Rate

The study included 10,315 physicians who answered questions related to burnout on the American Board of Family Medicine’s Continuous Certification Questionnaire between 2017 and 2023. Researchers achieved a 100% response rate by requiring diplomates to complete the survey before submitting their exam.

The median age of respondents was 50 years. More than half (57.8%) were employees, 11.3% were full owners of their practices, and 3.2% were contractors. Responses indicated that 10% practiced as solo physicians, 20.4% were in a practice with more than 20 physicians, and the rest were in a practice with 2-19 physicians. More than three fourths of the physicians practiced in an urban/suburban setting, and 13.5% practiced in a rural setting.

Physicians’ perceptions that EHR use at home was appropriate were associated with 0.58 times the odds of burnout (95% CI, 0.53-0.64; P < .001), and high team efficiency was associated with 0.61 times the odds of burnout (95% CI, 0.56-0.67).

Physician collaboration with a registered nurse was associated with greater odds of high team efficiency (odds ratio [OR], 1.35; 95% CI, 1.22-1.50). Collaboration with a physician assistant was associated with greater odds of appropriate home EHR time (OR, 1.13; 95% CI, 1.03-1.24).
 

Numbers Needed to Treat

“When translated to a number needed to treat, these ORs suggest that eight additional physicians perceiving appropriate home EHR time would result in prevention of one additional case of burnout, and nine additional physicians perceiving high team efficiency would result in prevention of one case of burnout,” the authors wrote.

The authors also noted that EHR proficiency was not associated with burnout (OR, 0.93; 95% CI, 0.85-1.02; P = .12). Self-reported EHR proficiency remained high and steady over the study period.

“It is time to lay to rest the myth of the technology-resistant physician,” Sinsky wrote in the editorial. “The problem is not the end user.”

Sinsky said the findings also show that value-based compensation “is not a panacea” and, in fact, participation in such payment programs was associated with both more time working on the EHR at home and lower team efficiency.

Fee-for-service models are often painted as the culprit, she noted.

“The key in either compensation model is to direct sufficient financial resources to primary care to cover the costs of optimal team size, skill level, and stability. In my experience, this is a minimum of two clinical assistants (including at least one nurse) per 1.0 clinical full-time equivalent physician, with the same team of individuals working together on a daily basis to develop trust, reliance, and efficiencies.”
 

 

 

Medical Assistants (MAs) Replacing Nurses on Core Teams

In many cases, nurses have been replaced on core clinical teams by MAs, who, with a narrower scope of practice, put work back on the physician’s plate, Sinsky noted, and the MAs also often work in pools rather than with one physician.

“The result is that nurses in many settings are sequestered in a room with a computer and a telephone, with limited direct interactions with their patients or physicians, and physicians spend more time each day on tasks that do not require their medical training,” Sinsky wrote.

Strengths of the study include the large sample size, a 100% response rate to the survey, and consistency of findings over the 6 years.

Steven Waldren, MD, MS, chief medical informatics officer for the American Academy of Family Physicians, said the results of the study confirm what the organization knows to be true through various analyses and talks with doctors: “Even if you can just focus on documentation and improve that, it gives docs hope that other things can happen and actually improve. We saw a decrease in burnout in just solving that one problem.”

Team-based care also allows physicians to talk through challenges and off-load tasks, which allows them to focus on patient care, he said.

Waldren added that some technology upgrades can help reduce burnout without adding staff. He pointed to promising technology in managing EHR inbox messages and in artificial intelligence (AI) solutions for developing a visit summary and patient instructions that can then be reviewed by a physician.

He gave an example of ambient documentation. “We’ve seen that it reduces the amount of documentation time by 60%-70%,” he said. The products in this space record the physician-patient conversation and generate a summary to be reviewed by the physician for accuracy.

“These tools now are highly accurate,” he said. They are also able to remove clinically irrelevant details. He said, for example, if a patient talks about her recent golf outing on a trip to Ireland, the program will record only that she recently had an international trip to Ireland and remove the golf details. The technology has been available for many months, he said.

Sonia Rivera-Martinez, DO, an associate professor of family medicine at the New York Institute of Technology College of Osteopathic Medicine in Old Westbury, New York, said AI solutions are impressive but expensive, which is why her practice has not upgraded to AI-generated visit summaries.

She said even in her academic setting where there is less pressure to see several patients per hour, after-hours EHR work is a reality for her and her colleagues as seeing patients is paired with the demands of teaching students. Her practice is also part of an accountable care organization, which adds its own set of documentation demands.
 

Nearly 30 Hours a Week of EHR Work at Home

Rivera-Martinez estimated that she spends 20-30 hours each week doing EHR tasks at home and said the study authors have highlighted an important problem.

She said she has also seen the value of strong nurse-physician teams in her practice. The two nurses in her practice, for instance, know they have permission to administer flu shots and do other routine tasks without the physicians having to place the order. “But I can’t say it eliminates having to do work outside (of work hours).”

She said before current EHR documentation demands, “I used to be able to finish a progress note in less than 5 minutes.” Now, she said, with her medically complex patient population, it takes her 20-30 minutes to complete a patient’s progress note.

The findings of the study have particular significance with the rising prevalence of burnout among family physicians, the authors wrote. “Clinical leaders and policymakers seeking to develop care delivery models that enable sustainable primary care practice should focus on ensuring adequate team support and acceptable EHR workloads for physicians.”

This study was funded by the United States Office of the National Coordinator for Health Information Technology and Department of Health and Human Services. Additionally, Rotenstein’s time was funded by The Physicians Foundation. Rotenstein reported personal fees from Phreesia; stock grants from serving on the advisory board of Augmedix; and grants from the Agency for Healthcare Research and Quality, American Medical Association, The Physicians Foundation, and Association of Chiefs and Leaders of General Internal Medicine outside the submitted work. Nathaniel Hendrix reported grants from the Office of the National Coordinator for Health Information Technology during the conduct of the study. One coauthor reported a cooperative agreement from the Office of the National Coordinator for Health Information Technology (now Assistant Secretary for Technology Policy/Office of the National Coordinator for Health Information Technology). Another coauthor reported that the University of California, San Francisco, has received funding from the Office of the National Coordinator for Health Information Technology to partner with the American Board of Family Medicine to revise the survey over time to better capture interoperability. Sinsky, Rivera-Martinez, and Waldren reported no relevant financial relationships.

A version of this article first appeared on Medscape.com.

Family physician burnout rates are among the highest in medicine. More than half (51%) reported burnout in a Medscape report from January 2024; only emergency physicians (63%) and obstetricians/gynecologists and oncologists (both 53%) had higher rates.

In a recent study, researchers examined what’s driving the burnout through a serial cross-sectional survey of family physicians. Authors conclude that reducing burnout may be most effective with a focus on two factors: Decreasing time spent at home on electronic health record (EHR) tasks and building stronger nurse-physician teams.

Findings by Lisa S. Rotenstein, MD, MBA, MSc, Division of Clinical Informatics, Department of Medicine, University of California, San Francisco, and colleagues were published in JAMA Network Open. The findings debunk some longstanding assumptions, Christine A. Sinsky, MD, vice president of professional satisfaction with the American Medical Association, wrote in an editorial.

“This study advances our understanding that addressing physician burnout is not about more EHR training and not specifically about moving to paying for value; rather, it is about developing stronger nurse-physician core teams. These are novel and important findings with actionable lessons for physician and health system leaders,” Sinsky wrote.
 

More Than 10,000 Physicians; 100% Response Rate

The study included 10,315 physicians who answered questions related to burnout on the American Board of Family Medicine’s Continuous Certification Questionnaire between 2017 and 2023. Researchers achieved a 100% response rate by requiring diplomates to complete the survey before submitting their exam.

The median age of respondents was 50 years. More than half (57.8%) were employees, 11.3% were full owners of their practices, and 3.2% were contractors. Responses indicated that 10% practiced as solo physicians, 20.4% were in a practice with more than 20 physicians, and the rest were in a practice with 2-19 physicians. More than three fourths of the physicians practiced in an urban/suburban setting, and 13.5% practiced in a rural setting.

Physicians’ perceptions that EHR use at home was appropriate were associated with 0.58 times the odds of burnout (95% CI, 0.53-0.64; P < .001), and high team efficiency was associated with 0.61 times the odds of burnout (95% CI, 0.56-0.67).

Physician collaboration with a registered nurse was associated with greater odds of high team efficiency (odds ratio [OR], 1.35; 95% CI, 1.22-1.50). Collaboration with a physician assistant was associated with greater odds of appropriate home EHR time (OR, 1.13; 95% CI, 1.03-1.24).
 

Numbers Needed to Treat

“When translated to a number needed to treat, these ORs suggest that eight additional physicians perceiving appropriate home EHR time would result in prevention of one additional case of burnout, and nine additional physicians perceiving high team efficiency would result in prevention of one case of burnout,” the authors wrote.

The authors also noted that EHR proficiency was not associated with burnout (OR, 0.93; 95% CI, 0.85-1.02; P = .12). Self-reported EHR proficiency remained high and steady over the study period.

“It is time to lay to rest the myth of the technology-resistant physician,” Sinsky wrote in the editorial. “The problem is not the end user.”

Sinsky said the findings also show that value-based compensation “is not a panacea” and, in fact, participation in such payment programs was associated with both more time working on the EHR at home and lower team efficiency.

Fee-for-service models are often painted as the culprit, she noted.

“The key in either compensation model is to direct sufficient financial resources to primary care to cover the costs of optimal team size, skill level, and stability. In my experience, this is a minimum of two clinical assistants (including at least one nurse) per 1.0 clinical full-time equivalent physician, with the same team of individuals working together on a daily basis to develop trust, reliance, and efficiencies.”
 

 

 

Medical Assistants (MAs) Replacing Nurses on Core Teams

In many cases, nurses have been replaced on core clinical teams by MAs, who, with a narrower scope of practice, put work back on the physician’s plate, Sinsky noted, and the MAs also often work in pools rather than with one physician.

“The result is that nurses in many settings are sequestered in a room with a computer and a telephone, with limited direct interactions with their patients or physicians, and physicians spend more time each day on tasks that do not require their medical training,” Sinsky wrote.

Strengths of the study include the large sample size, a 100% response rate to the survey, and consistency of findings over the 6 years.

Steven Waldren, MD, MS, chief medical informatics officer for the American Academy of Family Physicians, said the results of the study confirm what the organization knows to be true through various analyses and talks with doctors: “Even if you can just focus on documentation and improve that, it gives docs hope that other things can happen and actually improve. We saw a decrease in burnout in just solving that one problem.”

Team-based care also allows physicians to talk through challenges and off-load tasks, which allows them to focus on patient care, he said.

Waldren added that some technology upgrades can help reduce burnout without adding staff. He pointed to promising technology in managing EHR inbox messages and in artificial intelligence (AI) solutions for developing a visit summary and patient instructions that can then be reviewed by a physician.

He gave an example of ambient documentation. “We’ve seen that it reduces the amount of documentation time by 60%-70%,” he said. The products in this space record the physician-patient conversation and generate a summary to be reviewed by the physician for accuracy.

“These tools now are highly accurate,” he said. They are also able to remove clinically irrelevant details. He said, for example, if a patient talks about her recent golf outing on a trip to Ireland, the program will record only that she recently had an international trip to Ireland and remove the golf details. The technology has been available for many months, he said.

Sonia Rivera-Martinez, DO, an associate professor of family medicine at the New York Institute of Technology College of Osteopathic Medicine in Old Westbury, New York, said AI solutions are impressive but expensive, which is why her practice has not upgraded to AI-generated visit summaries.

She said even in her academic setting where there is less pressure to see several patients per hour, after-hours EHR work is a reality for her and her colleagues as seeing patients is paired with the demands of teaching students. Her practice is also part of an accountable care organization, which adds its own set of documentation demands.
 

Nearly 30 Hours a Week of EHR Work at Home

Rivera-Martinez estimated that she spends 20-30 hours each week doing EHR tasks at home and said the study authors have highlighted an important problem.

She said she has also seen the value of strong nurse-physician teams in her practice. The two nurses in her practice, for instance, know they have permission to administer flu shots and do other routine tasks without the physicians having to place the order. “But I can’t say it eliminates having to do work outside (of work hours).”

She said before current EHR documentation demands, “I used to be able to finish a progress note in less than 5 minutes.” Now, she said, with her medically complex patient population, it takes her 20-30 minutes to complete a patient’s progress note.

The findings of the study have particular significance with the rising prevalence of burnout among family physicians, the authors wrote. “Clinical leaders and policymakers seeking to develop care delivery models that enable sustainable primary care practice should focus on ensuring adequate team support and acceptable EHR workloads for physicians.”

This study was funded by the United States Office of the National Coordinator for Health Information Technology and Department of Health and Human Services. Additionally, Rotenstein’s time was funded by The Physicians Foundation. Rotenstein reported personal fees from Phreesia; stock grants from serving on the advisory board of Augmedix; and grants from the Agency for Healthcare Research and Quality, American Medical Association, The Physicians Foundation, and Association of Chiefs and Leaders of General Internal Medicine outside the submitted work. Nathaniel Hendrix reported grants from the Office of the National Coordinator for Health Information Technology during the conduct of the study. One coauthor reported a cooperative agreement from the Office of the National Coordinator for Health Information Technology (now Assistant Secretary for Technology Policy/Office of the National Coordinator for Health Information Technology). Another coauthor reported that the University of California, San Francisco, has received funding from the Office of the National Coordinator for Health Information Technology to partner with the American Board of Family Medicine to revise the survey over time to better capture interoperability. Sinsky, Rivera-Martinez, and Waldren reported no relevant financial relationships.

A version of this article first appeared on Medscape.com.

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How to Manage Patients on GLP-1s Before Surgery

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Tue, 11/12/2024 - 16:16

 

Guidance from professional societies on how to handle the risk for pulmonary aspiration during general anesthesia or deep sedation for patients taking glucagon-like peptide 1 receptor agonists (GLP-1 RAs) continues to evolve, as does the US Food and Drug Administration’s (FDA’s) labeling for the drugs. The changes can be challenging to keep up with, and endocrinologists seem to be making their own decisions based on clinical experience and their interpretations of the potential impact and value of the emerging information.

The latest FDA label change warns about the risk for pulmonary aspiration but notes “insufficient” data to inform recommendations to mitigate the risk in vulnerable patients. Yet, the latest multi-society guidance, led by the American Society of Anesthesiologists (ASA) and based on consensus, not evidence, has nuanced advice for managing patients at risk.

Does the FDA’s label change make a difference regarding the multi-society guidance, which was published earlier? “The answer is no,” Girish Joshi, MD, vice chair, ASA Committee on Practice Parameters, told this news organization. “The concern of increased pulmonary aspiration in patients who are on GLP-1 receptor agonists has been known, and that concern still exists. So, we started with not an assumption but the premise that patients on GLP-1 receptor agonists are at a higher risk of aspiration during sedation, analgesia, and/or general anesthesia. The FDA basically confirms what we say in the guidance.”

Joshi, professor in the Anesthesiology and Pain Management Department at UT Southwestern Medical Center, Dallas, aimed to make the guidance, which was published simultaneously in several society journals, more implementable with a letter to the editor of Anesthesiology. The key, he said, is to identify patients at higher risk for aspiration; all others would follow treatment as usual.

The letter highlights three overarching recommendations and then expands upon them: Standardized preoperative assessment for risk for delayed gastric emptying (yes/no); selective preoperative care plan based on delayed gastric emptying assessment and shared decision-making; and on the day of the procedure, reassess for delayed gastric emptying and mitigate risk if there is clinical concern.

But it seems as though, for now, endocrinologists are managing these patients as they see fit, within the parameters of any institutional guidance requirements. Here is what they said about their practice:

Amy E. Rothberg, MD, DABOM, director of the Weight Management Program & Rewind at the University of Michigan, Ann Arbor, Michigan, said, “I think it makes sense to inform our patients of the labeling and rare but potential adverse effects if they intend to undergo anesthesia for a scheduled procedure/surgery. There is never no risk of aspiration during anesthesia.”

“I find it a bit curious that ASA implies that those who experience GI side effects are more likely than those who do not to have this potential risk. I doubt there is evidence that those without GI side effects are necessarily ‘safer’ and a study to determine that is unlikely to take be conducted.”

“My institution does require a 1-week pause on GLP-1s for those undergoing anesthesia for surgery,” she added. “That’s not evidence-based either, but probably reduces the risk of aspiration during anesthesia — but I don’t know what the actual denominator is for aspiration in those who continued vs those who took a pause from GLP-1s. Pausing does certainly (anecdotally) increase the traffic of communications between physicians and their patients about what to do in the interval.”

Anne Peters, MD, a professor of clinical medicine and a clinical scholar at the Keck School of Medicine of the University of Southern California, Los Angeles, said, “The FDA label change is a warning that really doesn’t say exactly who on GLP-1 RAs is at highest risk or what to do, and if any intervention has been shown to help. The ASA recommendations seem much more nuanced and practical, including point-of-care gastric ultrasound to see if there is retained food/fluid prior to surgery.”

“In my practice, I individualize what I say, depending on the person and the circumstance,” she said. “Mostly, I have people hold one dose before planned surgery, so they have been 10 days at least without a dose. But if worried about gastrointestinal symptoms or gastroparesis, I have them do a clear liquid diet for 24 hours presurgery. Or at least avoid heavy fat meals the day before.”

“There is a risk of aspiration with anything that slows gastric emptying — maybe even in patients with gastroparesis at baseline due to physiologic, not pharmacological, reasons — and anesthesiologists should be aware of the need to assess patients individually.”

Michael A. Weintraub, MD, of NYU Langone Health Diabetes & Endocrine Associates in New York City, observed, “The risk of a pulmonary aspiration event with GLP-1 medication is quite rare, but not zero. On the other hand, stopping the GLP-1 can cause hyperglycemia or rebound weight gain. Furthermore, it can become complicated to restart GLP1 dosing, particularly given the existing medication shortages.”

“In most cases, stopping a weekly GLP-1 medication 1 week prior to the procedure minimizes the risks of pulmonary aspiration and prevents any worsening hyperglycemia or weight gain,” he said. However, taking the drug 7 days prior to the procedure is optimal. “That way, they would be due for the next dose on the day of the procedure, and taking it the day following procedure minimizes disruption in their once-weekly regimen.”

Malini Gupta, MD, director of G2Endo Endocrinology & Metabolism, Memphis, Tennessee, advised that physicians weigh the risk of stopping the medication (which can cause a glycemic spike) vs risk for aspiration.

“In my opinion, all patients should follow a strict liquid diet or NPO status prior to a surgery to further decrease the risk of aspiration,” she said. “I generally hold the GLP-1 RA for a week before a surgery. If additional glycemic control is necessary, I will add to or adjust one of the patient’s other diabetes medications.”

Jaime Almandoz, MD, associate professor of medicine and medical director of the Weight Wellness Program in Dallas, said, “As endocrinologists, we typically rely on our anesthesia colleagues for guidance on perioperative management. In light of emerging guidelines for holding GLP-1 medications, we also recommend patients adopt a liquid diet 24 hours prior to surgery, along with the fasting protocol.”

“For those managing diabetes with GLP-1 therapies, it is crucial to establish a blood sugar management plan while off these medications, especially during fasting or postoperative periods, which can be further influenced by many factors, including nausea, pain medications, and antibiotics after the procedure.”

Joshi added that at Parkland Hospital in Dallas, “we do a huge number of cases using the same information. We identify patients who are at risk, and then we tell our proceduralists and our surgeons if they’re in the escalating phase of the dosing or if they have GI symptoms; don’t even schedule them as an elective case; wait till the escalation phase is over and then schedule them.”

“That way,” he said, “it becomes logistically easy to manage because the recommendation from the group is that patients who are at higher risk should receive a 24-hour liquid diet — the same as colonoscopy. But sometimes it can be challenging to do so.”

Joshi has received honoraria for consultation from Merck Sharp & Dohme, Vertex Pharmaceuticals, and Haisco-USA Pharmaceuticals. Gupta is on the speakers bureau for Amgen (Tepezza) and IBSA (Tirosint) and is a creative consultant for AbbVie. Almandoz serves on advisory boards for Novo Nordisk, Eli Lilly, and Boehringer Ingelheim. The other experts declared no relevant relationships.
 

A version of this article first appeared on Medscape.com.

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Guidance from professional societies on how to handle the risk for pulmonary aspiration during general anesthesia or deep sedation for patients taking glucagon-like peptide 1 receptor agonists (GLP-1 RAs) continues to evolve, as does the US Food and Drug Administration’s (FDA’s) labeling for the drugs. The changes can be challenging to keep up with, and endocrinologists seem to be making their own decisions based on clinical experience and their interpretations of the potential impact and value of the emerging information.

The latest FDA label change warns about the risk for pulmonary aspiration but notes “insufficient” data to inform recommendations to mitigate the risk in vulnerable patients. Yet, the latest multi-society guidance, led by the American Society of Anesthesiologists (ASA) and based on consensus, not evidence, has nuanced advice for managing patients at risk.

Does the FDA’s label change make a difference regarding the multi-society guidance, which was published earlier? “The answer is no,” Girish Joshi, MD, vice chair, ASA Committee on Practice Parameters, told this news organization. “The concern of increased pulmonary aspiration in patients who are on GLP-1 receptor agonists has been known, and that concern still exists. So, we started with not an assumption but the premise that patients on GLP-1 receptor agonists are at a higher risk of aspiration during sedation, analgesia, and/or general anesthesia. The FDA basically confirms what we say in the guidance.”

Joshi, professor in the Anesthesiology and Pain Management Department at UT Southwestern Medical Center, Dallas, aimed to make the guidance, which was published simultaneously in several society journals, more implementable with a letter to the editor of Anesthesiology. The key, he said, is to identify patients at higher risk for aspiration; all others would follow treatment as usual.

The letter highlights three overarching recommendations and then expands upon them: Standardized preoperative assessment for risk for delayed gastric emptying (yes/no); selective preoperative care plan based on delayed gastric emptying assessment and shared decision-making; and on the day of the procedure, reassess for delayed gastric emptying and mitigate risk if there is clinical concern.

But it seems as though, for now, endocrinologists are managing these patients as they see fit, within the parameters of any institutional guidance requirements. Here is what they said about their practice:

Amy E. Rothberg, MD, DABOM, director of the Weight Management Program & Rewind at the University of Michigan, Ann Arbor, Michigan, said, “I think it makes sense to inform our patients of the labeling and rare but potential adverse effects if they intend to undergo anesthesia for a scheduled procedure/surgery. There is never no risk of aspiration during anesthesia.”

“I find it a bit curious that ASA implies that those who experience GI side effects are more likely than those who do not to have this potential risk. I doubt there is evidence that those without GI side effects are necessarily ‘safer’ and a study to determine that is unlikely to take be conducted.”

“My institution does require a 1-week pause on GLP-1s for those undergoing anesthesia for surgery,” she added. “That’s not evidence-based either, but probably reduces the risk of aspiration during anesthesia — but I don’t know what the actual denominator is for aspiration in those who continued vs those who took a pause from GLP-1s. Pausing does certainly (anecdotally) increase the traffic of communications between physicians and their patients about what to do in the interval.”

Anne Peters, MD, a professor of clinical medicine and a clinical scholar at the Keck School of Medicine of the University of Southern California, Los Angeles, said, “The FDA label change is a warning that really doesn’t say exactly who on GLP-1 RAs is at highest risk or what to do, and if any intervention has been shown to help. The ASA recommendations seem much more nuanced and practical, including point-of-care gastric ultrasound to see if there is retained food/fluid prior to surgery.”

“In my practice, I individualize what I say, depending on the person and the circumstance,” she said. “Mostly, I have people hold one dose before planned surgery, so they have been 10 days at least without a dose. But if worried about gastrointestinal symptoms or gastroparesis, I have them do a clear liquid diet for 24 hours presurgery. Or at least avoid heavy fat meals the day before.”

“There is a risk of aspiration with anything that slows gastric emptying — maybe even in patients with gastroparesis at baseline due to physiologic, not pharmacological, reasons — and anesthesiologists should be aware of the need to assess patients individually.”

Michael A. Weintraub, MD, of NYU Langone Health Diabetes & Endocrine Associates in New York City, observed, “The risk of a pulmonary aspiration event with GLP-1 medication is quite rare, but not zero. On the other hand, stopping the GLP-1 can cause hyperglycemia or rebound weight gain. Furthermore, it can become complicated to restart GLP1 dosing, particularly given the existing medication shortages.”

“In most cases, stopping a weekly GLP-1 medication 1 week prior to the procedure minimizes the risks of pulmonary aspiration and prevents any worsening hyperglycemia or weight gain,” he said. However, taking the drug 7 days prior to the procedure is optimal. “That way, they would be due for the next dose on the day of the procedure, and taking it the day following procedure minimizes disruption in their once-weekly regimen.”

Malini Gupta, MD, director of G2Endo Endocrinology & Metabolism, Memphis, Tennessee, advised that physicians weigh the risk of stopping the medication (which can cause a glycemic spike) vs risk for aspiration.

“In my opinion, all patients should follow a strict liquid diet or NPO status prior to a surgery to further decrease the risk of aspiration,” she said. “I generally hold the GLP-1 RA for a week before a surgery. If additional glycemic control is necessary, I will add to or adjust one of the patient’s other diabetes medications.”

Jaime Almandoz, MD, associate professor of medicine and medical director of the Weight Wellness Program in Dallas, said, “As endocrinologists, we typically rely on our anesthesia colleagues for guidance on perioperative management. In light of emerging guidelines for holding GLP-1 medications, we also recommend patients adopt a liquid diet 24 hours prior to surgery, along with the fasting protocol.”

“For those managing diabetes with GLP-1 therapies, it is crucial to establish a blood sugar management plan while off these medications, especially during fasting or postoperative periods, which can be further influenced by many factors, including nausea, pain medications, and antibiotics after the procedure.”

Joshi added that at Parkland Hospital in Dallas, “we do a huge number of cases using the same information. We identify patients who are at risk, and then we tell our proceduralists and our surgeons if they’re in the escalating phase of the dosing or if they have GI symptoms; don’t even schedule them as an elective case; wait till the escalation phase is over and then schedule them.”

“That way,” he said, “it becomes logistically easy to manage because the recommendation from the group is that patients who are at higher risk should receive a 24-hour liquid diet — the same as colonoscopy. But sometimes it can be challenging to do so.”

Joshi has received honoraria for consultation from Merck Sharp & Dohme, Vertex Pharmaceuticals, and Haisco-USA Pharmaceuticals. Gupta is on the speakers bureau for Amgen (Tepezza) and IBSA (Tirosint) and is a creative consultant for AbbVie. Almandoz serves on advisory boards for Novo Nordisk, Eli Lilly, and Boehringer Ingelheim. The other experts declared no relevant relationships.
 

A version of this article first appeared on Medscape.com.

 

Guidance from professional societies on how to handle the risk for pulmonary aspiration during general anesthesia or deep sedation for patients taking glucagon-like peptide 1 receptor agonists (GLP-1 RAs) continues to evolve, as does the US Food and Drug Administration’s (FDA’s) labeling for the drugs. The changes can be challenging to keep up with, and endocrinologists seem to be making their own decisions based on clinical experience and their interpretations of the potential impact and value of the emerging information.

The latest FDA label change warns about the risk for pulmonary aspiration but notes “insufficient” data to inform recommendations to mitigate the risk in vulnerable patients. Yet, the latest multi-society guidance, led by the American Society of Anesthesiologists (ASA) and based on consensus, not evidence, has nuanced advice for managing patients at risk.

Does the FDA’s label change make a difference regarding the multi-society guidance, which was published earlier? “The answer is no,” Girish Joshi, MD, vice chair, ASA Committee on Practice Parameters, told this news organization. “The concern of increased pulmonary aspiration in patients who are on GLP-1 receptor agonists has been known, and that concern still exists. So, we started with not an assumption but the premise that patients on GLP-1 receptor agonists are at a higher risk of aspiration during sedation, analgesia, and/or general anesthesia. The FDA basically confirms what we say in the guidance.”

Joshi, professor in the Anesthesiology and Pain Management Department at UT Southwestern Medical Center, Dallas, aimed to make the guidance, which was published simultaneously in several society journals, more implementable with a letter to the editor of Anesthesiology. The key, he said, is to identify patients at higher risk for aspiration; all others would follow treatment as usual.

The letter highlights three overarching recommendations and then expands upon them: Standardized preoperative assessment for risk for delayed gastric emptying (yes/no); selective preoperative care plan based on delayed gastric emptying assessment and shared decision-making; and on the day of the procedure, reassess for delayed gastric emptying and mitigate risk if there is clinical concern.

But it seems as though, for now, endocrinologists are managing these patients as they see fit, within the parameters of any institutional guidance requirements. Here is what they said about their practice:

Amy E. Rothberg, MD, DABOM, director of the Weight Management Program & Rewind at the University of Michigan, Ann Arbor, Michigan, said, “I think it makes sense to inform our patients of the labeling and rare but potential adverse effects if they intend to undergo anesthesia for a scheduled procedure/surgery. There is never no risk of aspiration during anesthesia.”

“I find it a bit curious that ASA implies that those who experience GI side effects are more likely than those who do not to have this potential risk. I doubt there is evidence that those without GI side effects are necessarily ‘safer’ and a study to determine that is unlikely to take be conducted.”

“My institution does require a 1-week pause on GLP-1s for those undergoing anesthesia for surgery,” she added. “That’s not evidence-based either, but probably reduces the risk of aspiration during anesthesia — but I don’t know what the actual denominator is for aspiration in those who continued vs those who took a pause from GLP-1s. Pausing does certainly (anecdotally) increase the traffic of communications between physicians and their patients about what to do in the interval.”

Anne Peters, MD, a professor of clinical medicine and a clinical scholar at the Keck School of Medicine of the University of Southern California, Los Angeles, said, “The FDA label change is a warning that really doesn’t say exactly who on GLP-1 RAs is at highest risk or what to do, and if any intervention has been shown to help. The ASA recommendations seem much more nuanced and practical, including point-of-care gastric ultrasound to see if there is retained food/fluid prior to surgery.”

“In my practice, I individualize what I say, depending on the person and the circumstance,” she said. “Mostly, I have people hold one dose before planned surgery, so they have been 10 days at least without a dose. But if worried about gastrointestinal symptoms or gastroparesis, I have them do a clear liquid diet for 24 hours presurgery. Or at least avoid heavy fat meals the day before.”

“There is a risk of aspiration with anything that slows gastric emptying — maybe even in patients with gastroparesis at baseline due to physiologic, not pharmacological, reasons — and anesthesiologists should be aware of the need to assess patients individually.”

Michael A. Weintraub, MD, of NYU Langone Health Diabetes & Endocrine Associates in New York City, observed, “The risk of a pulmonary aspiration event with GLP-1 medication is quite rare, but not zero. On the other hand, stopping the GLP-1 can cause hyperglycemia or rebound weight gain. Furthermore, it can become complicated to restart GLP1 dosing, particularly given the existing medication shortages.”

“In most cases, stopping a weekly GLP-1 medication 1 week prior to the procedure minimizes the risks of pulmonary aspiration and prevents any worsening hyperglycemia or weight gain,” he said. However, taking the drug 7 days prior to the procedure is optimal. “That way, they would be due for the next dose on the day of the procedure, and taking it the day following procedure minimizes disruption in their once-weekly regimen.”

Malini Gupta, MD, director of G2Endo Endocrinology & Metabolism, Memphis, Tennessee, advised that physicians weigh the risk of stopping the medication (which can cause a glycemic spike) vs risk for aspiration.

“In my opinion, all patients should follow a strict liquid diet or NPO status prior to a surgery to further decrease the risk of aspiration,” she said. “I generally hold the GLP-1 RA for a week before a surgery. If additional glycemic control is necessary, I will add to or adjust one of the patient’s other diabetes medications.”

Jaime Almandoz, MD, associate professor of medicine and medical director of the Weight Wellness Program in Dallas, said, “As endocrinologists, we typically rely on our anesthesia colleagues for guidance on perioperative management. In light of emerging guidelines for holding GLP-1 medications, we also recommend patients adopt a liquid diet 24 hours prior to surgery, along with the fasting protocol.”

“For those managing diabetes with GLP-1 therapies, it is crucial to establish a blood sugar management plan while off these medications, especially during fasting or postoperative periods, which can be further influenced by many factors, including nausea, pain medications, and antibiotics after the procedure.”

Joshi added that at Parkland Hospital in Dallas, “we do a huge number of cases using the same information. We identify patients who are at risk, and then we tell our proceduralists and our surgeons if they’re in the escalating phase of the dosing or if they have GI symptoms; don’t even schedule them as an elective case; wait till the escalation phase is over and then schedule them.”

“That way,” he said, “it becomes logistically easy to manage because the recommendation from the group is that patients who are at higher risk should receive a 24-hour liquid diet — the same as colonoscopy. But sometimes it can be challenging to do so.”

Joshi has received honoraria for consultation from Merck Sharp & Dohme, Vertex Pharmaceuticals, and Haisco-USA Pharmaceuticals. Gupta is on the speakers bureau for Amgen (Tepezza) and IBSA (Tirosint) and is a creative consultant for AbbVie. Almandoz serves on advisory boards for Novo Nordisk, Eli Lilly, and Boehringer Ingelheim. The other experts declared no relevant relationships.
 

A version of this article first appeared on Medscape.com.

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Continuous Glucose Monitors for All? Opinions Remain Mixed

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Wed, 11/13/2024 - 02:44

 

The recent US Food and Drug Administration (FDA) clearance of two over-the-counter (OTC) continuous glucose monitors (CGMs) — Dexcom’s Stelo and Abbott’s Lingo — has sparked interest in potentially expanding their use to those without diabetes or prediabetes.

There are several valid questions about how the general population might benefit from CGMs. Can they motivate those struggling with overweight to shed pounds? Would they prompt users to follow more healthful eating patterns? Can they act as a canary in the coal mine, alerting users to prediabetes? 

The short answer to these questions is, we don’t know.

“Glucose levels fluctuate in everyone in response to meals, exercise, stress, etc, but there has been no credible research to support CGM use by most people who do not have diabetes,” Jill Crandall, MD, chief of endocrinology at Albert Einstein College of Medicine and Montefiore Health System in New York City, said in an interview.

“The utility of CGM for people without diabetes hasn’t been established and the drive to market CGM as an OTC device seems largely driven by financial considerations,” Crandall said. She advocates instead for a strategy directed at more meaningful objectives.

“For now, efforts should be focused on making CGMs available to patients who will clearly benefit — ie, people with diabetes, especially those who are using insulin and those who are struggling to achieve desired levels of glucose control.” 

Nicole Spartano, PhD, assistant professor of medicine in endocrinology, diabetes, nutrition and weight management at Boston University’s Chobanian & Avedisian School of Medicine in Massachusetts, agreed with this assessment.

“It is definitely too early to make recommendations for patients without diabetes based on their CGM data,” said Spartano, who also serves as the director of the Glucose Monitoring Station at the Framingham Heart Study in Framingham, Massachusetts. “We simply do not have enough follow-up data to tell us which CGM metrics are associated with higher risk for disease.” 

Spartano served as the lead author of a recent study showing time spent in various CGM ranges in a large cohort of individuals without diabetes using the Dexcom G6 Pro model. In the future, she said the data may be used to establish reference ranges for clinicians and individuals.

“We are working on another paper surveying diabetologists and CGM experts about how they interpret CGM reports from individuals without diabetes,” she said in an interview. Although the data are not yet published, Spartano said, “we are finding that clinicians are currently very discordant in how they interpret these reports.”
 

Potential Benefits Right Now

Satish Garg, MD, director of the Adult Clinic at the Barbara Davis Center for Diabetes at the University of Colorado Anschutz Medical Campus, Aurora, and editor-in-chief of Diabetes Technology & Therapeutics, is convinced that glucose should be considered another vital sign, like blood pressure, pulse rate, respiration rate, and body temperature. Therefore, he sees the use of a CGM in people without diabetes as a way to build awareness and perhaps prompt behavior modification.

“Someone with an A1c of 4.9 on a normal day may notice that they’ve gained a little bit of weight, and if they use an OTC CGM and start seeing changes, it might help them to modulate their diet themselves, whether they see a dietitian or not,” Garg said.

He gave the example of “a natural behavioral change” occurring when someone using a CGM declines to eat a post-meal dessert after seeing their blood glucose had already risen to 170.

Wearing a CGM also has the potential to alert the user to high blood glucose, leading them to an earlier diagnosis of prediabetes or diabetes, Shichun Bao, MD, PhD, Diabetes Technology Program Leader at the Vanderbilt Eskind Diabetes Clinic of Vanderbilt University in Nashville, Tennessee, said in an interview. She has had cases where a family member of someone with diabetes used the patient’s fingerstick meter, found that their glucose was 280, and self-diagnosed with diabetes.

“It’s the same thing with the CGM,” she said. “If they somehow did not know they have diabetes and they wear a CGM and it shows their sugar is high, that will help them to know to see their provider to get a diagnosis, get treated, and track progression.”

Given the shortage of endocrinologists and long waits for appointments in the United States and elsewhere, it is very likely that primary care physicians will be the ones fielding questions from individuals without diabetes interested in purchasing an OTC CGM. Internist Douglas Paauw, MD, a professor at the University of Washington School of Medicine, Seattle, said in an interview that, for his practice, “the benefits outweigh some of the limitations.”

“I don’t really think somebody who doesn’t have diabetes needs to be using a CGM all the time or long term,” he said. “But I have used it in a few people without diabetes, and I think if someone can afford to use it for 2-4 weeks, especially if they’ve been gaining weight, then they can really recognize what happens to their bodies when they eat certain foods.”

Paauw added that CGMs are a more effective means of teaching his patients than them receiving a lecture from him on healthy eating. “There’s nothing like immediate feedback on what happens to your body to change behavior.”

Similarly, William Golden, medical director at Arkansas Medicaid and professor of medicine and public health at the University of Arkansas for Medical Sciences, Little Rock, said in an interview that “it is difficult to justify coverage for CGMs on demand — but if people want to invest in their own devices and the technology motivates them to eat better and/or lose weight, then there are benefits to be had.” 
 

 

 

Potential Downsides

Although it may seem simple to use an OTC CGM to measure blood glucose on the fly, in the real world it can take patients time to understand these devices, “especially the first day or so, when users are going to get false lows,” Bao said. “Clinicians need to tell them if you don’t feel like your sugar is low and the device says it’s low, whether they do or don’t have diabetes, they should do a fingerstick glucose test to confirm the low before rushing to take in sugar. On the other hand, if they drink a lot of juice, their sugar will go high. So, it can create problems and false results either way.”

Many factors affect glucose, she said. “When you’re sick, glucose can go high, and when you’re very sick, in the ICU, sometimes it can be low. It depends on the situation.” Bao noted that certain vitamins and drugs can also interfere with readings.

Bao doesn’t see value in having people without diabetes monitor their glucose continuously. “If they want to see what foods or exercise do to their body, they will probably benefit from a short trial to gain some insight; otherwise, they’re wasting money,” she said.

Another potential downside is that there’s no head-to-head comparison data with the approved devices, Garg said. “But it’s clear to us that Stelo’s range is very narrow, 70 to 200, whereas the Lingo ranges are pretty much full, from 40 to 400 or 55 to 400. So, we don’t know the accuracy of these sensors.”

Golden observed that for certain patients, CGMs may lead to psychological distress rather than providing a sense of control over their blood glucose levels.

“I have had a nondiabetic patient or two that obsessed about their blood sugars and a device would only magnify their anxiety/neurosis,” he said. “The bottom line is that it’s a tool for a balanced approach to health management, but the daily results must be kept in perspective!”
 

Educate Patients, Primary Care Physicians

To maximize potential benefits for patients without diabetes, clinicians need to be well trained in the use and interpretation of results from the devices, Bao said. They can then better educate their patients, including discussing with them possible pitfalls surrounding their use. 

“For example, a patient may see that their blood glucose, as measured by a fingerstick, is 95, whereas the CGM says 140, and ask, ‘Which one do I trust?’ ”

This is where the patient can be educated about the difference between interstitial glucose, as measured by the CGM, and blood glucose, as measured by the fingerstick. Because it takes about 15 minutes for blood glucose to get to the interstitial tissue, there’s lag time, and the two measurements will differ.

“A discrepancy of 20% is totally acceptable for that reason,” Bao said.

She has also seen several examples where patients were misled by their CGM when its censor became dislodged.

“Sometimes when a sensor has moved, the patient may push it back in because they don’t want to throw it away. But it doesn’t work that way, and they end up with inaccurate readings.” 

At a minimum, Bao added, clinicians and patients should read the package insert but also be aware that it doesn’t list everything that might go wrong or interfere with the device’s accuracy.

Manufacturers of OTC devices should be training primary care and family practice doctors in their use, given the expected “huge” influx of patients wanting to use them, according to Garg.

“If you are expecting endos or diabetes specialists to see these people, that’s never going to happen,” he said. “We have a big shortage of these specialists, so industry has to train these doctors. Patients will bring their doctor’s data, and the clinicians need to learn the basics of how to interpret the glucose values they see. Then they can treat these patients rather than shipping all of them to endos who likely are not available.”

Paauw agreed that CGM training should be directed largely toward primary care professionals, who can help their under-resourced endocrinologist colleagues from seeing an uptick in “the worried well.” 

“The bottom line is that primary care professionals do need to understand the CGM,” he said. “They do need to get comfortable with it. They do need to come up with opinions on how to use it. The public’s going to be using it, and we need to be competent in it and use our subspecialists appropriately.”

Spartano received funding for an investigator-initiated research grant from Novo Nordisk unrelated to the cited CGM studies. Garg , Bao, Paauw, Golden, and Crandall declared no relevant conflicts of interest.

A version of this article first appeared on Medscape.com.

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The recent US Food and Drug Administration (FDA) clearance of two over-the-counter (OTC) continuous glucose monitors (CGMs) — Dexcom’s Stelo and Abbott’s Lingo — has sparked interest in potentially expanding their use to those without diabetes or prediabetes.

There are several valid questions about how the general population might benefit from CGMs. Can they motivate those struggling with overweight to shed pounds? Would they prompt users to follow more healthful eating patterns? Can they act as a canary in the coal mine, alerting users to prediabetes? 

The short answer to these questions is, we don’t know.

“Glucose levels fluctuate in everyone in response to meals, exercise, stress, etc, but there has been no credible research to support CGM use by most people who do not have diabetes,” Jill Crandall, MD, chief of endocrinology at Albert Einstein College of Medicine and Montefiore Health System in New York City, said in an interview.

“The utility of CGM for people without diabetes hasn’t been established and the drive to market CGM as an OTC device seems largely driven by financial considerations,” Crandall said. She advocates instead for a strategy directed at more meaningful objectives.

“For now, efforts should be focused on making CGMs available to patients who will clearly benefit — ie, people with diabetes, especially those who are using insulin and those who are struggling to achieve desired levels of glucose control.” 

Nicole Spartano, PhD, assistant professor of medicine in endocrinology, diabetes, nutrition and weight management at Boston University’s Chobanian & Avedisian School of Medicine in Massachusetts, agreed with this assessment.

“It is definitely too early to make recommendations for patients without diabetes based on their CGM data,” said Spartano, who also serves as the director of the Glucose Monitoring Station at the Framingham Heart Study in Framingham, Massachusetts. “We simply do not have enough follow-up data to tell us which CGM metrics are associated with higher risk for disease.” 

Spartano served as the lead author of a recent study showing time spent in various CGM ranges in a large cohort of individuals without diabetes using the Dexcom G6 Pro model. In the future, she said the data may be used to establish reference ranges for clinicians and individuals.

“We are working on another paper surveying diabetologists and CGM experts about how they interpret CGM reports from individuals without diabetes,” she said in an interview. Although the data are not yet published, Spartano said, “we are finding that clinicians are currently very discordant in how they interpret these reports.”
 

Potential Benefits Right Now

Satish Garg, MD, director of the Adult Clinic at the Barbara Davis Center for Diabetes at the University of Colorado Anschutz Medical Campus, Aurora, and editor-in-chief of Diabetes Technology & Therapeutics, is convinced that glucose should be considered another vital sign, like blood pressure, pulse rate, respiration rate, and body temperature. Therefore, he sees the use of a CGM in people without diabetes as a way to build awareness and perhaps prompt behavior modification.

“Someone with an A1c of 4.9 on a normal day may notice that they’ve gained a little bit of weight, and if they use an OTC CGM and start seeing changes, it might help them to modulate their diet themselves, whether they see a dietitian or not,” Garg said.

He gave the example of “a natural behavioral change” occurring when someone using a CGM declines to eat a post-meal dessert after seeing their blood glucose had already risen to 170.

Wearing a CGM also has the potential to alert the user to high blood glucose, leading them to an earlier diagnosis of prediabetes or diabetes, Shichun Bao, MD, PhD, Diabetes Technology Program Leader at the Vanderbilt Eskind Diabetes Clinic of Vanderbilt University in Nashville, Tennessee, said in an interview. She has had cases where a family member of someone with diabetes used the patient’s fingerstick meter, found that their glucose was 280, and self-diagnosed with diabetes.

“It’s the same thing with the CGM,” she said. “If they somehow did not know they have diabetes and they wear a CGM and it shows their sugar is high, that will help them to know to see their provider to get a diagnosis, get treated, and track progression.”

Given the shortage of endocrinologists and long waits for appointments in the United States and elsewhere, it is very likely that primary care physicians will be the ones fielding questions from individuals without diabetes interested in purchasing an OTC CGM. Internist Douglas Paauw, MD, a professor at the University of Washington School of Medicine, Seattle, said in an interview that, for his practice, “the benefits outweigh some of the limitations.”

“I don’t really think somebody who doesn’t have diabetes needs to be using a CGM all the time or long term,” he said. “But I have used it in a few people without diabetes, and I think if someone can afford to use it for 2-4 weeks, especially if they’ve been gaining weight, then they can really recognize what happens to their bodies when they eat certain foods.”

Paauw added that CGMs are a more effective means of teaching his patients than them receiving a lecture from him on healthy eating. “There’s nothing like immediate feedback on what happens to your body to change behavior.”

Similarly, William Golden, medical director at Arkansas Medicaid and professor of medicine and public health at the University of Arkansas for Medical Sciences, Little Rock, said in an interview that “it is difficult to justify coverage for CGMs on demand — but if people want to invest in their own devices and the technology motivates them to eat better and/or lose weight, then there are benefits to be had.” 
 

 

 

Potential Downsides

Although it may seem simple to use an OTC CGM to measure blood glucose on the fly, in the real world it can take patients time to understand these devices, “especially the first day or so, when users are going to get false lows,” Bao said. “Clinicians need to tell them if you don’t feel like your sugar is low and the device says it’s low, whether they do or don’t have diabetes, they should do a fingerstick glucose test to confirm the low before rushing to take in sugar. On the other hand, if they drink a lot of juice, their sugar will go high. So, it can create problems and false results either way.”

Many factors affect glucose, she said. “When you’re sick, glucose can go high, and when you’re very sick, in the ICU, sometimes it can be low. It depends on the situation.” Bao noted that certain vitamins and drugs can also interfere with readings.

Bao doesn’t see value in having people without diabetes monitor their glucose continuously. “If they want to see what foods or exercise do to their body, they will probably benefit from a short trial to gain some insight; otherwise, they’re wasting money,” she said.

Another potential downside is that there’s no head-to-head comparison data with the approved devices, Garg said. “But it’s clear to us that Stelo’s range is very narrow, 70 to 200, whereas the Lingo ranges are pretty much full, from 40 to 400 or 55 to 400. So, we don’t know the accuracy of these sensors.”

Golden observed that for certain patients, CGMs may lead to psychological distress rather than providing a sense of control over their blood glucose levels.

“I have had a nondiabetic patient or two that obsessed about their blood sugars and a device would only magnify their anxiety/neurosis,” he said. “The bottom line is that it’s a tool for a balanced approach to health management, but the daily results must be kept in perspective!”
 

Educate Patients, Primary Care Physicians

To maximize potential benefits for patients without diabetes, clinicians need to be well trained in the use and interpretation of results from the devices, Bao said. They can then better educate their patients, including discussing with them possible pitfalls surrounding their use. 

“For example, a patient may see that their blood glucose, as measured by a fingerstick, is 95, whereas the CGM says 140, and ask, ‘Which one do I trust?’ ”

This is where the patient can be educated about the difference between interstitial glucose, as measured by the CGM, and blood glucose, as measured by the fingerstick. Because it takes about 15 minutes for blood glucose to get to the interstitial tissue, there’s lag time, and the two measurements will differ.

“A discrepancy of 20% is totally acceptable for that reason,” Bao said.

She has also seen several examples where patients were misled by their CGM when its censor became dislodged.

“Sometimes when a sensor has moved, the patient may push it back in because they don’t want to throw it away. But it doesn’t work that way, and they end up with inaccurate readings.” 

At a minimum, Bao added, clinicians and patients should read the package insert but also be aware that it doesn’t list everything that might go wrong or interfere with the device’s accuracy.

Manufacturers of OTC devices should be training primary care and family practice doctors in their use, given the expected “huge” influx of patients wanting to use them, according to Garg.

“If you are expecting endos or diabetes specialists to see these people, that’s never going to happen,” he said. “We have a big shortage of these specialists, so industry has to train these doctors. Patients will bring their doctor’s data, and the clinicians need to learn the basics of how to interpret the glucose values they see. Then they can treat these patients rather than shipping all of them to endos who likely are not available.”

Paauw agreed that CGM training should be directed largely toward primary care professionals, who can help their under-resourced endocrinologist colleagues from seeing an uptick in “the worried well.” 

“The bottom line is that primary care professionals do need to understand the CGM,” he said. “They do need to get comfortable with it. They do need to come up with opinions on how to use it. The public’s going to be using it, and we need to be competent in it and use our subspecialists appropriately.”

Spartano received funding for an investigator-initiated research grant from Novo Nordisk unrelated to the cited CGM studies. Garg , Bao, Paauw, Golden, and Crandall declared no relevant conflicts of interest.

A version of this article first appeared on Medscape.com.

 

The recent US Food and Drug Administration (FDA) clearance of two over-the-counter (OTC) continuous glucose monitors (CGMs) — Dexcom’s Stelo and Abbott’s Lingo — has sparked interest in potentially expanding their use to those without diabetes or prediabetes.

There are several valid questions about how the general population might benefit from CGMs. Can they motivate those struggling with overweight to shed pounds? Would they prompt users to follow more healthful eating patterns? Can they act as a canary in the coal mine, alerting users to prediabetes? 

The short answer to these questions is, we don’t know.

“Glucose levels fluctuate in everyone in response to meals, exercise, stress, etc, but there has been no credible research to support CGM use by most people who do not have diabetes,” Jill Crandall, MD, chief of endocrinology at Albert Einstein College of Medicine and Montefiore Health System in New York City, said in an interview.

“The utility of CGM for people without diabetes hasn’t been established and the drive to market CGM as an OTC device seems largely driven by financial considerations,” Crandall said. She advocates instead for a strategy directed at more meaningful objectives.

“For now, efforts should be focused on making CGMs available to patients who will clearly benefit — ie, people with diabetes, especially those who are using insulin and those who are struggling to achieve desired levels of glucose control.” 

Nicole Spartano, PhD, assistant professor of medicine in endocrinology, diabetes, nutrition and weight management at Boston University’s Chobanian & Avedisian School of Medicine in Massachusetts, agreed with this assessment.

“It is definitely too early to make recommendations for patients without diabetes based on their CGM data,” said Spartano, who also serves as the director of the Glucose Monitoring Station at the Framingham Heart Study in Framingham, Massachusetts. “We simply do not have enough follow-up data to tell us which CGM metrics are associated with higher risk for disease.” 

Spartano served as the lead author of a recent study showing time spent in various CGM ranges in a large cohort of individuals without diabetes using the Dexcom G6 Pro model. In the future, she said the data may be used to establish reference ranges for clinicians and individuals.

“We are working on another paper surveying diabetologists and CGM experts about how they interpret CGM reports from individuals without diabetes,” she said in an interview. Although the data are not yet published, Spartano said, “we are finding that clinicians are currently very discordant in how they interpret these reports.”
 

Potential Benefits Right Now

Satish Garg, MD, director of the Adult Clinic at the Barbara Davis Center for Diabetes at the University of Colorado Anschutz Medical Campus, Aurora, and editor-in-chief of Diabetes Technology & Therapeutics, is convinced that glucose should be considered another vital sign, like blood pressure, pulse rate, respiration rate, and body temperature. Therefore, he sees the use of a CGM in people without diabetes as a way to build awareness and perhaps prompt behavior modification.

“Someone with an A1c of 4.9 on a normal day may notice that they’ve gained a little bit of weight, and if they use an OTC CGM and start seeing changes, it might help them to modulate their diet themselves, whether they see a dietitian or not,” Garg said.

He gave the example of “a natural behavioral change” occurring when someone using a CGM declines to eat a post-meal dessert after seeing their blood glucose had already risen to 170.

Wearing a CGM also has the potential to alert the user to high blood glucose, leading them to an earlier diagnosis of prediabetes or diabetes, Shichun Bao, MD, PhD, Diabetes Technology Program Leader at the Vanderbilt Eskind Diabetes Clinic of Vanderbilt University in Nashville, Tennessee, said in an interview. She has had cases where a family member of someone with diabetes used the patient’s fingerstick meter, found that their glucose was 280, and self-diagnosed with diabetes.

“It’s the same thing with the CGM,” she said. “If they somehow did not know they have diabetes and they wear a CGM and it shows their sugar is high, that will help them to know to see their provider to get a diagnosis, get treated, and track progression.”

Given the shortage of endocrinologists and long waits for appointments in the United States and elsewhere, it is very likely that primary care physicians will be the ones fielding questions from individuals without diabetes interested in purchasing an OTC CGM. Internist Douglas Paauw, MD, a professor at the University of Washington School of Medicine, Seattle, said in an interview that, for his practice, “the benefits outweigh some of the limitations.”

“I don’t really think somebody who doesn’t have diabetes needs to be using a CGM all the time or long term,” he said. “But I have used it in a few people without diabetes, and I think if someone can afford to use it for 2-4 weeks, especially if they’ve been gaining weight, then they can really recognize what happens to their bodies when they eat certain foods.”

Paauw added that CGMs are a more effective means of teaching his patients than them receiving a lecture from him on healthy eating. “There’s nothing like immediate feedback on what happens to your body to change behavior.”

Similarly, William Golden, medical director at Arkansas Medicaid and professor of medicine and public health at the University of Arkansas for Medical Sciences, Little Rock, said in an interview that “it is difficult to justify coverage for CGMs on demand — but if people want to invest in their own devices and the technology motivates them to eat better and/or lose weight, then there are benefits to be had.” 
 

 

 

Potential Downsides

Although it may seem simple to use an OTC CGM to measure blood glucose on the fly, in the real world it can take patients time to understand these devices, “especially the first day or so, when users are going to get false lows,” Bao said. “Clinicians need to tell them if you don’t feel like your sugar is low and the device says it’s low, whether they do or don’t have diabetes, they should do a fingerstick glucose test to confirm the low before rushing to take in sugar. On the other hand, if they drink a lot of juice, their sugar will go high. So, it can create problems and false results either way.”

Many factors affect glucose, she said. “When you’re sick, glucose can go high, and when you’re very sick, in the ICU, sometimes it can be low. It depends on the situation.” Bao noted that certain vitamins and drugs can also interfere with readings.

Bao doesn’t see value in having people without diabetes monitor their glucose continuously. “If they want to see what foods or exercise do to their body, they will probably benefit from a short trial to gain some insight; otherwise, they’re wasting money,” she said.

Another potential downside is that there’s no head-to-head comparison data with the approved devices, Garg said. “But it’s clear to us that Stelo’s range is very narrow, 70 to 200, whereas the Lingo ranges are pretty much full, from 40 to 400 or 55 to 400. So, we don’t know the accuracy of these sensors.”

Golden observed that for certain patients, CGMs may lead to psychological distress rather than providing a sense of control over their blood glucose levels.

“I have had a nondiabetic patient or two that obsessed about their blood sugars and a device would only magnify their anxiety/neurosis,” he said. “The bottom line is that it’s a tool for a balanced approach to health management, but the daily results must be kept in perspective!”
 

Educate Patients, Primary Care Physicians

To maximize potential benefits for patients without diabetes, clinicians need to be well trained in the use and interpretation of results from the devices, Bao said. They can then better educate their patients, including discussing with them possible pitfalls surrounding their use. 

“For example, a patient may see that their blood glucose, as measured by a fingerstick, is 95, whereas the CGM says 140, and ask, ‘Which one do I trust?’ ”

This is where the patient can be educated about the difference between interstitial glucose, as measured by the CGM, and blood glucose, as measured by the fingerstick. Because it takes about 15 minutes for blood glucose to get to the interstitial tissue, there’s lag time, and the two measurements will differ.

“A discrepancy of 20% is totally acceptable for that reason,” Bao said.

She has also seen several examples where patients were misled by their CGM when its censor became dislodged.

“Sometimes when a sensor has moved, the patient may push it back in because they don’t want to throw it away. But it doesn’t work that way, and they end up with inaccurate readings.” 

At a minimum, Bao added, clinicians and patients should read the package insert but also be aware that it doesn’t list everything that might go wrong or interfere with the device’s accuracy.

Manufacturers of OTC devices should be training primary care and family practice doctors in their use, given the expected “huge” influx of patients wanting to use them, according to Garg.

“If you are expecting endos or diabetes specialists to see these people, that’s never going to happen,” he said. “We have a big shortage of these specialists, so industry has to train these doctors. Patients will bring their doctor’s data, and the clinicians need to learn the basics of how to interpret the glucose values they see. Then they can treat these patients rather than shipping all of them to endos who likely are not available.”

Paauw agreed that CGM training should be directed largely toward primary care professionals, who can help their under-resourced endocrinologist colleagues from seeing an uptick in “the worried well.” 

“The bottom line is that primary care professionals do need to understand the CGM,” he said. “They do need to get comfortable with it. They do need to come up with opinions on how to use it. The public’s going to be using it, and we need to be competent in it and use our subspecialists appropriately.”

Spartano received funding for an investigator-initiated research grant from Novo Nordisk unrelated to the cited CGM studies. Garg , Bao, Paauw, Golden, and Crandall declared no relevant conflicts of interest.

A version of this article first appeared on Medscape.com.

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Building an AI Army of Digital Twins to Fight Cancer

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Changed
Wed, 11/13/2024 - 09:41

A patient has cancer. It’s decision time.

Clinician and patient alike face, really, the ultimate challenge when making those decisions. They have to consider the patient’s individual circumstances, available treatment options, potential side effects, relevant clinical data such as the patient’s genetic profile and cancer specifics, and more.

“That’s a lot of information to hold,” said Uzma Asghar, PhD, MRCP, a British consultant medical oncologist at The Royal Marsden Hospital and a chief scientific officer at Concr LTD.

What if there were a way to test — quickly and accurately — all the potential paths forward?

That’s the goal of digital twins. An artificial intelligence (AI)–based program uses all the known data on patients and their types of illness and creates a “twin” that can be used over and over to simulate disease progression, test treatments, and predict individual responses to therapies.

“What the [digital twin] model can do for the clinician is to hold all that information and process it really quickly, within a couple of minutes,” Asghar noted.

A digital twin is more than just a computer model or simulation because it copies a real-world person and relies on real-world data. Some digital twin programs also integrate new information as it becomes available. This technology holds promise for personalized medicine, drug discovery, developing screening strategies, and better understanding diseases.
 

How to Deliver a Twin

To create a digital twin, experts develop a computer model with data to hone its expertise in an area of medicine, such as cancer types and treatments. Then “you train the model on information it’s seen, and then introduce a patient and patient’s information,” said Asghar.

Asghar is currently working with colleagues to develop digital twins that could eventually help solve the aforementioned cancer scenario — a doctor and patient decide the best course of cancer treatment. But their applications are manifold, particularly in clinical research.

Digital twins often include a machine learning component, which would fall under the umbrella term of AI, said Asghar, but it’s not like ChatGPT or other generative AI modules many people are now familiar with.

“The difference here is the model is not there to replace the clinician or to replace clinical trials,” Asghar noted. Instead, digital twins help make decisions faster in a way that can be more affordable.
 

Digital Twins to Predict Cancer Outcomes

Asghar is currently involved in UK clinical trials enrolling patients with cancer to test the accuracy of digital twin programs.

At this point, these studies do not yet use digital twins to guide the course of treatment, which is something they hope to do eventually. For now, they are still at the validation phase — the digital twin program makes predictions about the treatments and then the researchers later evaluate how accurate the predictions turned out to be based on real information from the enrolled patients.

Their current model gives predictions for RECIST (response evaluation criteria in solid tumor), treatment response, and survival. In addition to collecting data from ongoing clinical trials, they’ve used retrospective data, such as from the Cancer Tumor Atlas, to test the model.

“We’ve clinically validated it now in over 9000 patients,” said Asghar, who noted that they are constantly testing it on new patients. Their data include 30 chemotherapies and 23 cancer types, but they are focusing on four: Triple-negative breast cancer, cancer of unknown primary, pancreatic cancer, and colorectal cancer.

“The reason for choosing those four cancer types is that they are aggressive, their response to chemotherapy isn’t as great, and the outcome for those patient populations, there’s significant room for improvement,” Asghar explained.

Currently, Asghar said, the model is around 80%-90% correct in predicting what the actual clinical outcomes turn out to be.

The final stage of their work, before it becomes widely available to clinicians, will be to integrate it into a clinical trial in which some clinicians use the model to make decisions about treatment vs some who don’t use the model. By studying patient outcomes in both groups, they will be able to determine the value of the digital twin program they created.
 

 

 

What Else Can a Twin Do? A Lot

While a model that helps clinicians make decisions about cancer treatments may be among the first digital twin programs that become widely available, there are many other kinds of digital twins in the works.

For example, a digital twin could be used as a benchmark for a patient to determine how their cancer might have progressed without treatment. Say a patient’s tumor grew during treatment, it might seem like the treatment failed, but a digital twin might show that if left untreated, the tumor would have grown five times as fast, said Paul Macklin, PhD, professor in the Department of Intelligent Systems Engineering at Indiana University Bloomington.

Alternatively, if the virtual patient’s tumor is around the same size as the real patient’s tumor, “that means that treatment has lost its efficacy. It’s time to do something new,” said Macklin. And a digital twin could help with not only choosing a therapy but also choosing a dosing schedule, he noted.

The models can also be updated as new treatments come out, which could help clinicians virtually explore how they might affect a patient before having that patient switch treatments.

Digital twins could also assist in decision-making based on a patient’s priorities and real-life circumstances. “Maybe your priority is not necessarily to shrink this [tumor] at all costs ... maybe your priority is some mix of that and also quality of life,” Macklin said, referring to potential side effects. Or if someone lives 3 hours from the nearest cancer center, a digital twin could help determine whether less frequent treatments could still be effective.

And while much of the activity around digital twins in biomedical research has been focused on cancer, Asghar said the technology has the potential to be applied to other diseases as well. A digital twin for cardiovascular disease could help doctors choose the best treatment. It could also integrate new information from a smartwatch or glucose monitor to make better predictions and help doctors adjust the treatment plan.
 

Faster, More Effective Research With Twins

Because digital twin programs can quickly analyze large datasets, they can also make real-world studies more effective and efficient.

Though digital twins would not fully replace real clinical trials, they could help run through preliminary scenarios before starting a full clinical trial, which would “save everybody some money, time and pain and risk,” said Macklin.

It’s also possible to use digital twins to design better screening strategies for early cancer detection and monitoring, said Ioannis Zervantonakis, PhD, a bioengineering professor at the University of Pittsburgh.

Zervantonakis is tapping digital twin technology for research that homes in on understanding tumors. In this case, the digital twin is a virtual representation of a real tumor, complete with its complex network of cells and the surrounding tissue.

Zervantonakis’ lab is using the technology to study cell-cell interactions in the tumor microenvironment, with a focus on human epidermal growth factor receptor 2–targeted therapy resistance in breast cancer. The digital twin they developed will simulate tumor growth, predict drug response, analyze cellular interactions, and optimize treatment strategies.
 

 

 

The Long Push Forward

One big hurdle to making digital twins more widely available is that regulation for the technology is still in progress.

“We’re developing the technology, and what’s also happening is the regulatory framework is being developed in parallel. So we’re almost developing things blindly on the basis that we think this is what the regulators would want,” explained Asghar.

“It’s really important that these technologies are regulated properly, just like drugs, and that’s what we’re pushing and advocating for,” said Asghar, noting that people need to know that like drugs, a digital twin has strengths and limitations.

And while a digital twin can be a cost-saving approach in the long run, it does require funding to get a program built, and finding funds can be difficult because not everyone knows about the technology. More funding means more trials.

With more data, Asghar is hopeful that within a few years, a digital twin model could be available for clinicians to use to help inform treatment decisions. This could lead to more effective treatments and, ultimately, better patient outcomes.
 

A version of this article appeared on Medscape.com.

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A patient has cancer. It’s decision time.

Clinician and patient alike face, really, the ultimate challenge when making those decisions. They have to consider the patient’s individual circumstances, available treatment options, potential side effects, relevant clinical data such as the patient’s genetic profile and cancer specifics, and more.

“That’s a lot of information to hold,” said Uzma Asghar, PhD, MRCP, a British consultant medical oncologist at The Royal Marsden Hospital and a chief scientific officer at Concr LTD.

What if there were a way to test — quickly and accurately — all the potential paths forward?

That’s the goal of digital twins. An artificial intelligence (AI)–based program uses all the known data on patients and their types of illness and creates a “twin” that can be used over and over to simulate disease progression, test treatments, and predict individual responses to therapies.

“What the [digital twin] model can do for the clinician is to hold all that information and process it really quickly, within a couple of minutes,” Asghar noted.

A digital twin is more than just a computer model or simulation because it copies a real-world person and relies on real-world data. Some digital twin programs also integrate new information as it becomes available. This technology holds promise for personalized medicine, drug discovery, developing screening strategies, and better understanding diseases.
 

How to Deliver a Twin

To create a digital twin, experts develop a computer model with data to hone its expertise in an area of medicine, such as cancer types and treatments. Then “you train the model on information it’s seen, and then introduce a patient and patient’s information,” said Asghar.

Asghar is currently working with colleagues to develop digital twins that could eventually help solve the aforementioned cancer scenario — a doctor and patient decide the best course of cancer treatment. But their applications are manifold, particularly in clinical research.

Digital twins often include a machine learning component, which would fall under the umbrella term of AI, said Asghar, but it’s not like ChatGPT or other generative AI modules many people are now familiar with.

“The difference here is the model is not there to replace the clinician or to replace clinical trials,” Asghar noted. Instead, digital twins help make decisions faster in a way that can be more affordable.
 

Digital Twins to Predict Cancer Outcomes

Asghar is currently involved in UK clinical trials enrolling patients with cancer to test the accuracy of digital twin programs.

At this point, these studies do not yet use digital twins to guide the course of treatment, which is something they hope to do eventually. For now, they are still at the validation phase — the digital twin program makes predictions about the treatments and then the researchers later evaluate how accurate the predictions turned out to be based on real information from the enrolled patients.

Their current model gives predictions for RECIST (response evaluation criteria in solid tumor), treatment response, and survival. In addition to collecting data from ongoing clinical trials, they’ve used retrospective data, such as from the Cancer Tumor Atlas, to test the model.

“We’ve clinically validated it now in over 9000 patients,” said Asghar, who noted that they are constantly testing it on new patients. Their data include 30 chemotherapies and 23 cancer types, but they are focusing on four: Triple-negative breast cancer, cancer of unknown primary, pancreatic cancer, and colorectal cancer.

“The reason for choosing those four cancer types is that they are aggressive, their response to chemotherapy isn’t as great, and the outcome for those patient populations, there’s significant room for improvement,” Asghar explained.

Currently, Asghar said, the model is around 80%-90% correct in predicting what the actual clinical outcomes turn out to be.

The final stage of their work, before it becomes widely available to clinicians, will be to integrate it into a clinical trial in which some clinicians use the model to make decisions about treatment vs some who don’t use the model. By studying patient outcomes in both groups, they will be able to determine the value of the digital twin program they created.
 

 

 

What Else Can a Twin Do? A Lot

While a model that helps clinicians make decisions about cancer treatments may be among the first digital twin programs that become widely available, there are many other kinds of digital twins in the works.

For example, a digital twin could be used as a benchmark for a patient to determine how their cancer might have progressed without treatment. Say a patient’s tumor grew during treatment, it might seem like the treatment failed, but a digital twin might show that if left untreated, the tumor would have grown five times as fast, said Paul Macklin, PhD, professor in the Department of Intelligent Systems Engineering at Indiana University Bloomington.

Alternatively, if the virtual patient’s tumor is around the same size as the real patient’s tumor, “that means that treatment has lost its efficacy. It’s time to do something new,” said Macklin. And a digital twin could help with not only choosing a therapy but also choosing a dosing schedule, he noted.

The models can also be updated as new treatments come out, which could help clinicians virtually explore how they might affect a patient before having that patient switch treatments.

Digital twins could also assist in decision-making based on a patient’s priorities and real-life circumstances. “Maybe your priority is not necessarily to shrink this [tumor] at all costs ... maybe your priority is some mix of that and also quality of life,” Macklin said, referring to potential side effects. Or if someone lives 3 hours from the nearest cancer center, a digital twin could help determine whether less frequent treatments could still be effective.

And while much of the activity around digital twins in biomedical research has been focused on cancer, Asghar said the technology has the potential to be applied to other diseases as well. A digital twin for cardiovascular disease could help doctors choose the best treatment. It could also integrate new information from a smartwatch or glucose monitor to make better predictions and help doctors adjust the treatment plan.
 

Faster, More Effective Research With Twins

Because digital twin programs can quickly analyze large datasets, they can also make real-world studies more effective and efficient.

Though digital twins would not fully replace real clinical trials, they could help run through preliminary scenarios before starting a full clinical trial, which would “save everybody some money, time and pain and risk,” said Macklin.

It’s also possible to use digital twins to design better screening strategies for early cancer detection and monitoring, said Ioannis Zervantonakis, PhD, a bioengineering professor at the University of Pittsburgh.

Zervantonakis is tapping digital twin technology for research that homes in on understanding tumors. In this case, the digital twin is a virtual representation of a real tumor, complete with its complex network of cells and the surrounding tissue.

Zervantonakis’ lab is using the technology to study cell-cell interactions in the tumor microenvironment, with a focus on human epidermal growth factor receptor 2–targeted therapy resistance in breast cancer. The digital twin they developed will simulate tumor growth, predict drug response, analyze cellular interactions, and optimize treatment strategies.
 

 

 

The Long Push Forward

One big hurdle to making digital twins more widely available is that regulation for the technology is still in progress.

“We’re developing the technology, and what’s also happening is the regulatory framework is being developed in parallel. So we’re almost developing things blindly on the basis that we think this is what the regulators would want,” explained Asghar.

“It’s really important that these technologies are regulated properly, just like drugs, and that’s what we’re pushing and advocating for,” said Asghar, noting that people need to know that like drugs, a digital twin has strengths and limitations.

And while a digital twin can be a cost-saving approach in the long run, it does require funding to get a program built, and finding funds can be difficult because not everyone knows about the technology. More funding means more trials.

With more data, Asghar is hopeful that within a few years, a digital twin model could be available for clinicians to use to help inform treatment decisions. This could lead to more effective treatments and, ultimately, better patient outcomes.
 

A version of this article appeared on Medscape.com.

A patient has cancer. It’s decision time.

Clinician and patient alike face, really, the ultimate challenge when making those decisions. They have to consider the patient’s individual circumstances, available treatment options, potential side effects, relevant clinical data such as the patient’s genetic profile and cancer specifics, and more.

“That’s a lot of information to hold,” said Uzma Asghar, PhD, MRCP, a British consultant medical oncologist at The Royal Marsden Hospital and a chief scientific officer at Concr LTD.

What if there were a way to test — quickly and accurately — all the potential paths forward?

That’s the goal of digital twins. An artificial intelligence (AI)–based program uses all the known data on patients and their types of illness and creates a “twin” that can be used over and over to simulate disease progression, test treatments, and predict individual responses to therapies.

“What the [digital twin] model can do for the clinician is to hold all that information and process it really quickly, within a couple of minutes,” Asghar noted.

A digital twin is more than just a computer model or simulation because it copies a real-world person and relies on real-world data. Some digital twin programs also integrate new information as it becomes available. This technology holds promise for personalized medicine, drug discovery, developing screening strategies, and better understanding diseases.
 

How to Deliver a Twin

To create a digital twin, experts develop a computer model with data to hone its expertise in an area of medicine, such as cancer types and treatments. Then “you train the model on information it’s seen, and then introduce a patient and patient’s information,” said Asghar.

Asghar is currently working with colleagues to develop digital twins that could eventually help solve the aforementioned cancer scenario — a doctor and patient decide the best course of cancer treatment. But their applications are manifold, particularly in clinical research.

Digital twins often include a machine learning component, which would fall under the umbrella term of AI, said Asghar, but it’s not like ChatGPT or other generative AI modules many people are now familiar with.

“The difference here is the model is not there to replace the clinician or to replace clinical trials,” Asghar noted. Instead, digital twins help make decisions faster in a way that can be more affordable.
 

Digital Twins to Predict Cancer Outcomes

Asghar is currently involved in UK clinical trials enrolling patients with cancer to test the accuracy of digital twin programs.

At this point, these studies do not yet use digital twins to guide the course of treatment, which is something they hope to do eventually. For now, they are still at the validation phase — the digital twin program makes predictions about the treatments and then the researchers later evaluate how accurate the predictions turned out to be based on real information from the enrolled patients.

Their current model gives predictions for RECIST (response evaluation criteria in solid tumor), treatment response, and survival. In addition to collecting data from ongoing clinical trials, they’ve used retrospective data, such as from the Cancer Tumor Atlas, to test the model.

“We’ve clinically validated it now in over 9000 patients,” said Asghar, who noted that they are constantly testing it on new patients. Their data include 30 chemotherapies and 23 cancer types, but they are focusing on four: Triple-negative breast cancer, cancer of unknown primary, pancreatic cancer, and colorectal cancer.

“The reason for choosing those four cancer types is that they are aggressive, their response to chemotherapy isn’t as great, and the outcome for those patient populations, there’s significant room for improvement,” Asghar explained.

Currently, Asghar said, the model is around 80%-90% correct in predicting what the actual clinical outcomes turn out to be.

The final stage of their work, before it becomes widely available to clinicians, will be to integrate it into a clinical trial in which some clinicians use the model to make decisions about treatment vs some who don’t use the model. By studying patient outcomes in both groups, they will be able to determine the value of the digital twin program they created.
 

 

 

What Else Can a Twin Do? A Lot

While a model that helps clinicians make decisions about cancer treatments may be among the first digital twin programs that become widely available, there are many other kinds of digital twins in the works.

For example, a digital twin could be used as a benchmark for a patient to determine how their cancer might have progressed without treatment. Say a patient’s tumor grew during treatment, it might seem like the treatment failed, but a digital twin might show that if left untreated, the tumor would have grown five times as fast, said Paul Macklin, PhD, professor in the Department of Intelligent Systems Engineering at Indiana University Bloomington.

Alternatively, if the virtual patient’s tumor is around the same size as the real patient’s tumor, “that means that treatment has lost its efficacy. It’s time to do something new,” said Macklin. And a digital twin could help with not only choosing a therapy but also choosing a dosing schedule, he noted.

The models can also be updated as new treatments come out, which could help clinicians virtually explore how they might affect a patient before having that patient switch treatments.

Digital twins could also assist in decision-making based on a patient’s priorities and real-life circumstances. “Maybe your priority is not necessarily to shrink this [tumor] at all costs ... maybe your priority is some mix of that and also quality of life,” Macklin said, referring to potential side effects. Or if someone lives 3 hours from the nearest cancer center, a digital twin could help determine whether less frequent treatments could still be effective.

And while much of the activity around digital twins in biomedical research has been focused on cancer, Asghar said the technology has the potential to be applied to other diseases as well. A digital twin for cardiovascular disease could help doctors choose the best treatment. It could also integrate new information from a smartwatch or glucose monitor to make better predictions and help doctors adjust the treatment plan.
 

Faster, More Effective Research With Twins

Because digital twin programs can quickly analyze large datasets, they can also make real-world studies more effective and efficient.

Though digital twins would not fully replace real clinical trials, they could help run through preliminary scenarios before starting a full clinical trial, which would “save everybody some money, time and pain and risk,” said Macklin.

It’s also possible to use digital twins to design better screening strategies for early cancer detection and monitoring, said Ioannis Zervantonakis, PhD, a bioengineering professor at the University of Pittsburgh.

Zervantonakis is tapping digital twin technology for research that homes in on understanding tumors. In this case, the digital twin is a virtual representation of a real tumor, complete with its complex network of cells and the surrounding tissue.

Zervantonakis’ lab is using the technology to study cell-cell interactions in the tumor microenvironment, with a focus on human epidermal growth factor receptor 2–targeted therapy resistance in breast cancer. The digital twin they developed will simulate tumor growth, predict drug response, analyze cellular interactions, and optimize treatment strategies.
 

 

 

The Long Push Forward

One big hurdle to making digital twins more widely available is that regulation for the technology is still in progress.

“We’re developing the technology, and what’s also happening is the regulatory framework is being developed in parallel. So we’re almost developing things blindly on the basis that we think this is what the regulators would want,” explained Asghar.

“It’s really important that these technologies are regulated properly, just like drugs, and that’s what we’re pushing and advocating for,” said Asghar, noting that people need to know that like drugs, a digital twin has strengths and limitations.

And while a digital twin can be a cost-saving approach in the long run, it does require funding to get a program built, and finding funds can be difficult because not everyone knows about the technology. More funding means more trials.

With more data, Asghar is hopeful that within a few years, a digital twin model could be available for clinicians to use to help inform treatment decisions. This could lead to more effective treatments and, ultimately, better patient outcomes.
 

A version of this article appeared on Medscape.com.

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Smokeless Tobacco, Areca Nut Chewing Behind 1 in 3 Oral Cancers: IARC Report

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Wed, 11/13/2024 - 09:38

Globally, nearly one in three cases of oral cancer can be attributed to use of smokeless tobacco and areca nut products, according to a new study from the International Agency for Research on Cancer (IARC), a part of the World Health Organization (WHO).

“Smokeless tobacco and areca nut products are available to consumers in many different forms across the world, but consuming smokeless tobacco and areca nut is linked to multiple diseases, including oral cancer,” Harriet Rumgay, PhD, a scientist in the Cancer Surveillance Branch at IARC and first author of the study in Lancet Oncology, said in a news release.

Worldwide, about 300 million people use smokeless tobacco and 600 million people use areca (also called betel) nut, one of the most popular psychoactive substances in the world after nicotine, alcohol, and caffeine. Smokeless tobacco products are consumed without burning and can be chewed, sucked, inhaled, applied locally, or ingested. Areca nut is the seed of the areca palm and can be consumed in various forms.

“Our estimates highlight the burden these products pose on health care and the importance of prevention strategies to reduce consumption of smokeless tobacco and areca nut,” Rumgay said.

According to the new report, in 2022, an estimated 120,200 of the 389,800 (30.8%) global cases of oral cancer were attributable to these products.

More than three quarters (77%) of attributable cases were among men and about one quarter (23%) among women.

The vast majority (96%) of all oral cancer cases caused by smokeless tobacco and areca nut use occurred in low- and middle-income countries.

Regions with the highest burden of oral cancers from these products were Southcentral Asia — with 105,500 of 120,200 cases (nearly 88%), including 83,400 in India, 9700 in Bangladesh, 8900 in Pakistan, and 1300 in Sri Lanka — followed by Southeastern Asia with a total of 3900 cases (1600 in Myanmar, 990 in Indonesia, and 785 in Thailand) and East Asia with 3300 cases (3200 in China).
 

Limitations and Action Points

The authors noted a limitation of the analysis is not accounting for the potential synergistic effects of combined use of smokeless tobacco or areca nut products with other risk factors for oral cancer, such as smoking tobacco or drinking alcohol.

The researchers explained that combined consumption of smokeless tobacco or areca nut, smoked tobacco, and alcohol has a “multiplicative effect” on oral cancer risk, with reported odds ratios increasing from 2.7 for smokeless tobacco only, 7.0 for smoked tobacco only, and 1.6 for alcohol only to 16.2 for all three exposures (vs no use).

However, the proportion of people who chewed tobacco and also smoked in countries with high smokeless tobacco or areca nut use was small. In India, for example, 6% of men and 0.5% of women in 2016-2017 were dual users of both smoked and smokeless tobacco, compared with 23% of men and 12% of women who only used smokeless tobacco.

Overall, curbing or preventing smokeless tobacco and areca nut use could help avoid many instances of oral cancer.

Despite “encouraging trends” in control of tobacco smoking in many regions of the world over the past two decades, progress in reducing the prevalence of smokeless tobacco consumption has stalled in many countries that are major consumers, the authors said.

Compounding the problem, areca nut does not fall within the WHO framework of tobacco control and there are very few areca nut control policies worldwide.

Smokeless tobacco control must be “prioritized” and a framework on areca nut control should be developed with guidelines to incorporate areca nut prevention into cancer control programs, the authors concluded.

Funding for the study was provided by the French National Cancer Institute. The authors had no relevant disclosures.

A version of this article first appeared on Medscape.com.

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Globally, nearly one in three cases of oral cancer can be attributed to use of smokeless tobacco and areca nut products, according to a new study from the International Agency for Research on Cancer (IARC), a part of the World Health Organization (WHO).

“Smokeless tobacco and areca nut products are available to consumers in many different forms across the world, but consuming smokeless tobacco and areca nut is linked to multiple diseases, including oral cancer,” Harriet Rumgay, PhD, a scientist in the Cancer Surveillance Branch at IARC and first author of the study in Lancet Oncology, said in a news release.

Worldwide, about 300 million people use smokeless tobacco and 600 million people use areca (also called betel) nut, one of the most popular psychoactive substances in the world after nicotine, alcohol, and caffeine. Smokeless tobacco products are consumed without burning and can be chewed, sucked, inhaled, applied locally, or ingested. Areca nut is the seed of the areca palm and can be consumed in various forms.

“Our estimates highlight the burden these products pose on health care and the importance of prevention strategies to reduce consumption of smokeless tobacco and areca nut,” Rumgay said.

According to the new report, in 2022, an estimated 120,200 of the 389,800 (30.8%) global cases of oral cancer were attributable to these products.

More than three quarters (77%) of attributable cases were among men and about one quarter (23%) among women.

The vast majority (96%) of all oral cancer cases caused by smokeless tobacco and areca nut use occurred in low- and middle-income countries.

Regions with the highest burden of oral cancers from these products were Southcentral Asia — with 105,500 of 120,200 cases (nearly 88%), including 83,400 in India, 9700 in Bangladesh, 8900 in Pakistan, and 1300 in Sri Lanka — followed by Southeastern Asia with a total of 3900 cases (1600 in Myanmar, 990 in Indonesia, and 785 in Thailand) and East Asia with 3300 cases (3200 in China).
 

Limitations and Action Points

The authors noted a limitation of the analysis is not accounting for the potential synergistic effects of combined use of smokeless tobacco or areca nut products with other risk factors for oral cancer, such as smoking tobacco or drinking alcohol.

The researchers explained that combined consumption of smokeless tobacco or areca nut, smoked tobacco, and alcohol has a “multiplicative effect” on oral cancer risk, with reported odds ratios increasing from 2.7 for smokeless tobacco only, 7.0 for smoked tobacco only, and 1.6 for alcohol only to 16.2 for all three exposures (vs no use).

However, the proportion of people who chewed tobacco and also smoked in countries with high smokeless tobacco or areca nut use was small. In India, for example, 6% of men and 0.5% of women in 2016-2017 were dual users of both smoked and smokeless tobacco, compared with 23% of men and 12% of women who only used smokeless tobacco.

Overall, curbing or preventing smokeless tobacco and areca nut use could help avoid many instances of oral cancer.

Despite “encouraging trends” in control of tobacco smoking in many regions of the world over the past two decades, progress in reducing the prevalence of smokeless tobacco consumption has stalled in many countries that are major consumers, the authors said.

Compounding the problem, areca nut does not fall within the WHO framework of tobacco control and there are very few areca nut control policies worldwide.

Smokeless tobacco control must be “prioritized” and a framework on areca nut control should be developed with guidelines to incorporate areca nut prevention into cancer control programs, the authors concluded.

Funding for the study was provided by the French National Cancer Institute. The authors had no relevant disclosures.

A version of this article first appeared on Medscape.com.

Globally, nearly one in three cases of oral cancer can be attributed to use of smokeless tobacco and areca nut products, according to a new study from the International Agency for Research on Cancer (IARC), a part of the World Health Organization (WHO).

“Smokeless tobacco and areca nut products are available to consumers in many different forms across the world, but consuming smokeless tobacco and areca nut is linked to multiple diseases, including oral cancer,” Harriet Rumgay, PhD, a scientist in the Cancer Surveillance Branch at IARC and first author of the study in Lancet Oncology, said in a news release.

Worldwide, about 300 million people use smokeless tobacco and 600 million people use areca (also called betel) nut, one of the most popular psychoactive substances in the world after nicotine, alcohol, and caffeine. Smokeless tobacco products are consumed without burning and can be chewed, sucked, inhaled, applied locally, or ingested. Areca nut is the seed of the areca palm and can be consumed in various forms.

“Our estimates highlight the burden these products pose on health care and the importance of prevention strategies to reduce consumption of smokeless tobacco and areca nut,” Rumgay said.

According to the new report, in 2022, an estimated 120,200 of the 389,800 (30.8%) global cases of oral cancer were attributable to these products.

More than three quarters (77%) of attributable cases were among men and about one quarter (23%) among women.

The vast majority (96%) of all oral cancer cases caused by smokeless tobacco and areca nut use occurred in low- and middle-income countries.

Regions with the highest burden of oral cancers from these products were Southcentral Asia — with 105,500 of 120,200 cases (nearly 88%), including 83,400 in India, 9700 in Bangladesh, 8900 in Pakistan, and 1300 in Sri Lanka — followed by Southeastern Asia with a total of 3900 cases (1600 in Myanmar, 990 in Indonesia, and 785 in Thailand) and East Asia with 3300 cases (3200 in China).
 

Limitations and Action Points

The authors noted a limitation of the analysis is not accounting for the potential synergistic effects of combined use of smokeless tobacco or areca nut products with other risk factors for oral cancer, such as smoking tobacco or drinking alcohol.

The researchers explained that combined consumption of smokeless tobacco or areca nut, smoked tobacco, and alcohol has a “multiplicative effect” on oral cancer risk, with reported odds ratios increasing from 2.7 for smokeless tobacco only, 7.0 for smoked tobacco only, and 1.6 for alcohol only to 16.2 for all three exposures (vs no use).

However, the proportion of people who chewed tobacco and also smoked in countries with high smokeless tobacco or areca nut use was small. In India, for example, 6% of men and 0.5% of women in 2016-2017 were dual users of both smoked and smokeless tobacco, compared with 23% of men and 12% of women who only used smokeless tobacco.

Overall, curbing or preventing smokeless tobacco and areca nut use could help avoid many instances of oral cancer.

Despite “encouraging trends” in control of tobacco smoking in many regions of the world over the past two decades, progress in reducing the prevalence of smokeless tobacco consumption has stalled in many countries that are major consumers, the authors said.

Compounding the problem, areca nut does not fall within the WHO framework of tobacco control and there are very few areca nut control policies worldwide.

Smokeless tobacco control must be “prioritized” and a framework on areca nut control should be developed with guidelines to incorporate areca nut prevention into cancer control programs, the authors concluded.

Funding for the study was provided by the French National Cancer Institute. The authors had no relevant disclosures.

A version of this article first appeared on Medscape.com.

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