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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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Ferritin Cutoff Values Affect Diagnosis of Iron Deficiency

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Mon, 09/30/2024 - 11:46

Ferritin is the parameter most often used in primary care to diagnose iron deficiency. The cutoff value of ferritin can affect the number of cases diagnosed, however. A study published in JAMA Network Open  investigated how different cutoff values affect the diagnosis of iron deficiency.

The study, which included 255,351 adult primary care patients in Switzerland, showed that ferritin cutoff values of 15, 30, and 45 ng/mL were associated with incidences of iron deficiency diagnoses of 10.9, 29.9, and 48.3 cases per 1000 patient-years, respectively. In other words, as the cutoff value increases, the frequency of diagnosis also increases.

“It is a study to take into account, especially because of the number of patients it includes, and it can guide primary care clinical practice. As expected, as the cutoff point increases with respect to ferritin values, the incidence percentages of both iron deficiency and iron-deficiency anemia also increase,” Miguel Turégano-Yedro, MD, a family physician at the Casar de Cáceres Health Center in Spain, and coordinator of the Hematology Working Group of the Spanish Society of Primary Care Physicians, told this news organization. Ferritin is the most sensitive parameter for diagnosing iron deficiency and iron-deficiency anemia, he added. “When it is necessary to supplement a patient with iron, other parameters are taken into account, such as hemoglobin, to see if there is anemia.”
 

Ferritin Level

The ferritin level associated with iron deficiency in primary care is usually 15 ng/mL, said Dr. Turégano-Yedro. “If we assess patients with a ferritin level of 15 or less than 15, then we know that many cases will be symptomatic (with fatigue, tiredness, or lack of appetite) and, therefore, will need iron treatment. But if the ferritin cutoff value is increased to 30 ng/mL or 45 ng/mL, the incidence will be higher, although in many cases they will be asymptomatic and iron supplementation will not be necessary.”

He also pointed out that he does not consider it necessary to raise the cutoff to 45 ng/mL; however, “establishing the cutoff at 30 ng/mL, in a certain population at risk of iron deficiency or iron-deficiency anemia, may be interesting, for example in women of childbearing age, women with very heavy menstruation, children, frail elderly, people with gastrointestinal bleeding, or those who engage in physical exercise.”

Iron deficiency must be distinguished from anemia. “If the ferritin is below 15 ng/mL, there is iron deficiency, which may or may not be accompanied by symptoms, although usually most patients will have symptoms. Normally, to diagnose a patient with iron-deficiency anemia, on the one hand, they must have low hemoglobin, which indicates anemia, and on the other hand, low ferritin, which indicates iron deficiency.” Taking these parameters into account, the study does have a weakness. “It is striking that a percentage of patients in the study requested ferritin analysis without including hemoglobin, when hemoglobin is part of the basic analysis performed in Spain,” said Dr. Turégano-Yedro.
 

When to Supplement

The study highlights the incidence of nonanemic iron deficiency diagnoses associated with the choice of ferritin cutoff value. However, as Dr. Turégano-Yedro explained, the percentage of patients who have iron deficiency but do not have anemia is not very relevant. “In the case of family physicians in Spain, it is not usually taken into account, because if a patient has iron deficiency with or without anemia and is symptomatic, they should be given iron supplements.”

What if they do not have a deficiency but do have anemia? “In principle, iron supplementation is not necessary, because that anemia may be due to chronic disorders or it may be hemolytic anemia, so the case should be studied,” Dr. Turégano-Yedro concluded.

This story was translated from Univadis Spain, which is part of the Medscape Professional Network, 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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Ferritin is the parameter most often used in primary care to diagnose iron deficiency. The cutoff value of ferritin can affect the number of cases diagnosed, however. A study published in JAMA Network Open  investigated how different cutoff values affect the diagnosis of iron deficiency.

The study, which included 255,351 adult primary care patients in Switzerland, showed that ferritin cutoff values of 15, 30, and 45 ng/mL were associated with incidences of iron deficiency diagnoses of 10.9, 29.9, and 48.3 cases per 1000 patient-years, respectively. In other words, as the cutoff value increases, the frequency of diagnosis also increases.

“It is a study to take into account, especially because of the number of patients it includes, and it can guide primary care clinical practice. As expected, as the cutoff point increases with respect to ferritin values, the incidence percentages of both iron deficiency and iron-deficiency anemia also increase,” Miguel Turégano-Yedro, MD, a family physician at the Casar de Cáceres Health Center in Spain, and coordinator of the Hematology Working Group of the Spanish Society of Primary Care Physicians, told this news organization. Ferritin is the most sensitive parameter for diagnosing iron deficiency and iron-deficiency anemia, he added. “When it is necessary to supplement a patient with iron, other parameters are taken into account, such as hemoglobin, to see if there is anemia.”
 

Ferritin Level

The ferritin level associated with iron deficiency in primary care is usually 15 ng/mL, said Dr. Turégano-Yedro. “If we assess patients with a ferritin level of 15 or less than 15, then we know that many cases will be symptomatic (with fatigue, tiredness, or lack of appetite) and, therefore, will need iron treatment. But if the ferritin cutoff value is increased to 30 ng/mL or 45 ng/mL, the incidence will be higher, although in many cases they will be asymptomatic and iron supplementation will not be necessary.”

He also pointed out that he does not consider it necessary to raise the cutoff to 45 ng/mL; however, “establishing the cutoff at 30 ng/mL, in a certain population at risk of iron deficiency or iron-deficiency anemia, may be interesting, for example in women of childbearing age, women with very heavy menstruation, children, frail elderly, people with gastrointestinal bleeding, or those who engage in physical exercise.”

Iron deficiency must be distinguished from anemia. “If the ferritin is below 15 ng/mL, there is iron deficiency, which may or may not be accompanied by symptoms, although usually most patients will have symptoms. Normally, to diagnose a patient with iron-deficiency anemia, on the one hand, they must have low hemoglobin, which indicates anemia, and on the other hand, low ferritin, which indicates iron deficiency.” Taking these parameters into account, the study does have a weakness. “It is striking that a percentage of patients in the study requested ferritin analysis without including hemoglobin, when hemoglobin is part of the basic analysis performed in Spain,” said Dr. Turégano-Yedro.
 

When to Supplement

The study highlights the incidence of nonanemic iron deficiency diagnoses associated with the choice of ferritin cutoff value. However, as Dr. Turégano-Yedro explained, the percentage of patients who have iron deficiency but do not have anemia is not very relevant. “In the case of family physicians in Spain, it is not usually taken into account, because if a patient has iron deficiency with or without anemia and is symptomatic, they should be given iron supplements.”

What if they do not have a deficiency but do have anemia? “In principle, iron supplementation is not necessary, because that anemia may be due to chronic disorders or it may be hemolytic anemia, so the case should be studied,” Dr. Turégano-Yedro concluded.

This story was translated from Univadis Spain, which is part of the Medscape Professional Network, 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.

Ferritin is the parameter most often used in primary care to diagnose iron deficiency. The cutoff value of ferritin can affect the number of cases diagnosed, however. A study published in JAMA Network Open  investigated how different cutoff values affect the diagnosis of iron deficiency.

The study, which included 255,351 adult primary care patients in Switzerland, showed that ferritin cutoff values of 15, 30, and 45 ng/mL were associated with incidences of iron deficiency diagnoses of 10.9, 29.9, and 48.3 cases per 1000 patient-years, respectively. In other words, as the cutoff value increases, the frequency of diagnosis also increases.

“It is a study to take into account, especially because of the number of patients it includes, and it can guide primary care clinical practice. As expected, as the cutoff point increases with respect to ferritin values, the incidence percentages of both iron deficiency and iron-deficiency anemia also increase,” Miguel Turégano-Yedro, MD, a family physician at the Casar de Cáceres Health Center in Spain, and coordinator of the Hematology Working Group of the Spanish Society of Primary Care Physicians, told this news organization. Ferritin is the most sensitive parameter for diagnosing iron deficiency and iron-deficiency anemia, he added. “When it is necessary to supplement a patient with iron, other parameters are taken into account, such as hemoglobin, to see if there is anemia.”
 

Ferritin Level

The ferritin level associated with iron deficiency in primary care is usually 15 ng/mL, said Dr. Turégano-Yedro. “If we assess patients with a ferritin level of 15 or less than 15, then we know that many cases will be symptomatic (with fatigue, tiredness, or lack of appetite) and, therefore, will need iron treatment. But if the ferritin cutoff value is increased to 30 ng/mL or 45 ng/mL, the incidence will be higher, although in many cases they will be asymptomatic and iron supplementation will not be necessary.”

He also pointed out that he does not consider it necessary to raise the cutoff to 45 ng/mL; however, “establishing the cutoff at 30 ng/mL, in a certain population at risk of iron deficiency or iron-deficiency anemia, may be interesting, for example in women of childbearing age, women with very heavy menstruation, children, frail elderly, people with gastrointestinal bleeding, or those who engage in physical exercise.”

Iron deficiency must be distinguished from anemia. “If the ferritin is below 15 ng/mL, there is iron deficiency, which may or may not be accompanied by symptoms, although usually most patients will have symptoms. Normally, to diagnose a patient with iron-deficiency anemia, on the one hand, they must have low hemoglobin, which indicates anemia, and on the other hand, low ferritin, which indicates iron deficiency.” Taking these parameters into account, the study does have a weakness. “It is striking that a percentage of patients in the study requested ferritin analysis without including hemoglobin, when hemoglobin is part of the basic analysis performed in Spain,” said Dr. Turégano-Yedro.
 

When to Supplement

The study highlights the incidence of nonanemic iron deficiency diagnoses associated with the choice of ferritin cutoff value. However, as Dr. Turégano-Yedro explained, the percentage of patients who have iron deficiency but do not have anemia is not very relevant. “In the case of family physicians in Spain, it is not usually taken into account, because if a patient has iron deficiency with or without anemia and is symptomatic, they should be given iron supplements.”

What if they do not have a deficiency but do have anemia? “In principle, iron supplementation is not necessary, because that anemia may be due to chronic disorders or it may be hemolytic anemia, so the case should be studied,” Dr. Turégano-Yedro concluded.

This story was translated from Univadis Spain, which is part of the Medscape Professional Network, 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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Could Eyelid Imaging Aid Early Diagnosis of Sjögren Disease?

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A noninvasive eye test could help people with Sjögren disease — a disorder that can go undiagnosed for years — get relief sooner, suggested a pilot study published in Therapeutic Advances in Musculoskeletal Disease.

Researchers led by Jing Wu, Department of Ophthalmology, Tongren Hospital, Shanghai Jiao Tong University School of Medicine, Shanghai, China, and colleagues used infrared imaging to detect atrophy of the oil-producing meibomian glands, which lubricate the eyelids and eyes, in 56 patients with suspected Sjögren disease. The test can be administered by an eye care practitioner using a Keratograph 5M machine. Patients also underwent salivary gland biopsies to detect Sjögren disease.

A total of 34 patients diagnosed with primary Sjögren disease had more significant atrophy and shortening of the meibomian glands in their upper eyelids than 22 patients with other types of dry eye who served as control patients. The accuracy of temporal and total meibomian gland dysfunction dropout rates in the upper eyelids to predict primary Sjögren disease classification was good, with an area under the curve of 0.94 and 0.91, respectively.

“Sjögren’s-related dry eye is definitely inflammatory,” said Esen Akpek, MD, director of the Ocular Surface Disease and Dry Eye Clinic at Johns Hopkins Medicine, Baltimore, who was not involved with the study. “It starts as inflammation, and then the inflammation spreads to the meibomian glands, to the conjunctiva, cornea, and there will be other findings, like corneal ulcers, corneal melts, cyclitis, retinitis, optic neuritis, uveitis, all these inflammatory diseases of the eye could happen with Sjögren’s.”

With other types of dry eye, such as blepharitis or even meibomian gland dysfunction without Sjögren disease, inflammation is usually confined to the ocular surface, Akpek said. As a result, symptoms tend to be less severe and progressive.

The results of this small study need validation in a larger cohort, said Steven Carsons, MD, chief of the Division of Rheumatology at NYU Langone Hospital–Long Island, who was not involved with the study. In general, however, noninvasive alternatives to today’s tests for Sjögren disease could be useful for patients and physicians.

“The definitive diagnosis is a minor salivary glandular biopsy, which is invasive and isn’t really appealing to a lot of patients,” Dr. Carsons said. This test can also be difficult to access if patients don’t live near a medical center that specializes in Sjögren disease, he said.

“I think it’s everybody’s goal to have a noninvasive test be able, at some point, to replace biopsy,” Dr. Carsons said.

Then there are blood tests. “The other more objective test, the SSA antibodies, are not very specific for Sjögren’s syndrome,” he said. “They’re fairly sensitive, but can also be seen in other autoimmune conditions, particularly lupus.”

With existing tools, however, optometrists and ophthalmologists can do more to diagnose Sjögren disease early, Dr. Akpek said.

“The issue with Sjögren’s is not that there are no earlier diagnostic aids or anything like that,” Dr. Akpek said.

Lissamine green, a dye that stains degraded cells on the eye’s surface, can reveal clues in young adult patients before other signs. “In my opinion, the earliest clinical finding that indicates presence of the disease is lissamine green staining of conjunctiva,” Akpek said.

Meibomian gland imaging would detect the disease at a later point. “By the time you get meibomian gland dysfunction, there has been longer-standing inflammation,” she said.

Two challenges hold back diagnoses, she said. One is that many practitioners mistakenly believe Sjögren disease is just a nuisance even though it can threaten vision through ocular complications and have more far-reaching effects, too.

“There are a lot of extraglandular systemic manifestations of Sjögren’s that cause morbidity in these patients,” Dr. Akpek said. For example, Sjögren disease is associated with lymphoma and other malignanciesinterstitial nephritisautoimmune hepatitis, and interstitial lung disease with fibrosis.

The second challenge, she said, is that many ophthalmologists and optometrists assume rheumatologists will make the Sjögren disease diagnosis first and then refer patients to them. But eye doctors are well positioned to spot the first signs — if they look for them.

“When you complain of dry eye, unless the doctor puts certain dyes and takes a look at the surface with the dye staining, they can’t see that you are dry,” Dr. Akpek said.

Unfortunately, these tests are underutilized. “I’m sorry to say, dry eye testing, like clinical testing, is not very commonly done,” she said. “Dry eye is managed according to patient symptoms. A lot of the time, Sjögren’s patients have such severe dry eye that they don’t complain of dryness anymore because their corneas become numb.”

Another way to prevent diagnostic delay is to collaborate, communicate, and carefully review patient records shared by other specialists.

“Particularly because of the wide involvement of different organ systems, such as the eyes, the mouth with dental problems, and then systemic features, including joints, it really does need the cooperation of ophthalmologists, dental specialists, and rheumatologists — immunologists sometimes — to come together and make this diagnosis,” Dr. Carsons said.

The study was supported by grants from the National Natural Science Foundation of China. The authors had no relevant disclosures.
 

A version of this article appeared on Medscape.com.

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A noninvasive eye test could help people with Sjögren disease — a disorder that can go undiagnosed for years — get relief sooner, suggested a pilot study published in Therapeutic Advances in Musculoskeletal Disease.

Researchers led by Jing Wu, Department of Ophthalmology, Tongren Hospital, Shanghai Jiao Tong University School of Medicine, Shanghai, China, and colleagues used infrared imaging to detect atrophy of the oil-producing meibomian glands, which lubricate the eyelids and eyes, in 56 patients with suspected Sjögren disease. The test can be administered by an eye care practitioner using a Keratograph 5M machine. Patients also underwent salivary gland biopsies to detect Sjögren disease.

A total of 34 patients diagnosed with primary Sjögren disease had more significant atrophy and shortening of the meibomian glands in their upper eyelids than 22 patients with other types of dry eye who served as control patients. The accuracy of temporal and total meibomian gland dysfunction dropout rates in the upper eyelids to predict primary Sjögren disease classification was good, with an area under the curve of 0.94 and 0.91, respectively.

“Sjögren’s-related dry eye is definitely inflammatory,” said Esen Akpek, MD, director of the Ocular Surface Disease and Dry Eye Clinic at Johns Hopkins Medicine, Baltimore, who was not involved with the study. “It starts as inflammation, and then the inflammation spreads to the meibomian glands, to the conjunctiva, cornea, and there will be other findings, like corneal ulcers, corneal melts, cyclitis, retinitis, optic neuritis, uveitis, all these inflammatory diseases of the eye could happen with Sjögren’s.”

With other types of dry eye, such as blepharitis or even meibomian gland dysfunction without Sjögren disease, inflammation is usually confined to the ocular surface, Akpek said. As a result, symptoms tend to be less severe and progressive.

The results of this small study need validation in a larger cohort, said Steven Carsons, MD, chief of the Division of Rheumatology at NYU Langone Hospital–Long Island, who was not involved with the study. In general, however, noninvasive alternatives to today’s tests for Sjögren disease could be useful for patients and physicians.

“The definitive diagnosis is a minor salivary glandular biopsy, which is invasive and isn’t really appealing to a lot of patients,” Dr. Carsons said. This test can also be difficult to access if patients don’t live near a medical center that specializes in Sjögren disease, he said.

“I think it’s everybody’s goal to have a noninvasive test be able, at some point, to replace biopsy,” Dr. Carsons said.

Then there are blood tests. “The other more objective test, the SSA antibodies, are not very specific for Sjögren’s syndrome,” he said. “They’re fairly sensitive, but can also be seen in other autoimmune conditions, particularly lupus.”

With existing tools, however, optometrists and ophthalmologists can do more to diagnose Sjögren disease early, Dr. Akpek said.

“The issue with Sjögren’s is not that there are no earlier diagnostic aids or anything like that,” Dr. Akpek said.

Lissamine green, a dye that stains degraded cells on the eye’s surface, can reveal clues in young adult patients before other signs. “In my opinion, the earliest clinical finding that indicates presence of the disease is lissamine green staining of conjunctiva,” Akpek said.

Meibomian gland imaging would detect the disease at a later point. “By the time you get meibomian gland dysfunction, there has been longer-standing inflammation,” she said.

Two challenges hold back diagnoses, she said. One is that many practitioners mistakenly believe Sjögren disease is just a nuisance even though it can threaten vision through ocular complications and have more far-reaching effects, too.

“There are a lot of extraglandular systemic manifestations of Sjögren’s that cause morbidity in these patients,” Dr. Akpek said. For example, Sjögren disease is associated with lymphoma and other malignanciesinterstitial nephritisautoimmune hepatitis, and interstitial lung disease with fibrosis.

The second challenge, she said, is that many ophthalmologists and optometrists assume rheumatologists will make the Sjögren disease diagnosis first and then refer patients to them. But eye doctors are well positioned to spot the first signs — if they look for them.

“When you complain of dry eye, unless the doctor puts certain dyes and takes a look at the surface with the dye staining, they can’t see that you are dry,” Dr. Akpek said.

Unfortunately, these tests are underutilized. “I’m sorry to say, dry eye testing, like clinical testing, is not very commonly done,” she said. “Dry eye is managed according to patient symptoms. A lot of the time, Sjögren’s patients have such severe dry eye that they don’t complain of dryness anymore because their corneas become numb.”

Another way to prevent diagnostic delay is to collaborate, communicate, and carefully review patient records shared by other specialists.

“Particularly because of the wide involvement of different organ systems, such as the eyes, the mouth with dental problems, and then systemic features, including joints, it really does need the cooperation of ophthalmologists, dental specialists, and rheumatologists — immunologists sometimes — to come together and make this diagnosis,” Dr. Carsons said.

The study was supported by grants from the National Natural Science Foundation of China. The authors had no relevant disclosures.
 

A version of this article appeared on Medscape.com.

A noninvasive eye test could help people with Sjögren disease — a disorder that can go undiagnosed for years — get relief sooner, suggested a pilot study published in Therapeutic Advances in Musculoskeletal Disease.

Researchers led by Jing Wu, Department of Ophthalmology, Tongren Hospital, Shanghai Jiao Tong University School of Medicine, Shanghai, China, and colleagues used infrared imaging to detect atrophy of the oil-producing meibomian glands, which lubricate the eyelids and eyes, in 56 patients with suspected Sjögren disease. The test can be administered by an eye care practitioner using a Keratograph 5M machine. Patients also underwent salivary gland biopsies to detect Sjögren disease.

A total of 34 patients diagnosed with primary Sjögren disease had more significant atrophy and shortening of the meibomian glands in their upper eyelids than 22 patients with other types of dry eye who served as control patients. The accuracy of temporal and total meibomian gland dysfunction dropout rates in the upper eyelids to predict primary Sjögren disease classification was good, with an area under the curve of 0.94 and 0.91, respectively.

“Sjögren’s-related dry eye is definitely inflammatory,” said Esen Akpek, MD, director of the Ocular Surface Disease and Dry Eye Clinic at Johns Hopkins Medicine, Baltimore, who was not involved with the study. “It starts as inflammation, and then the inflammation spreads to the meibomian glands, to the conjunctiva, cornea, and there will be other findings, like corneal ulcers, corneal melts, cyclitis, retinitis, optic neuritis, uveitis, all these inflammatory diseases of the eye could happen with Sjögren’s.”

With other types of dry eye, such as blepharitis or even meibomian gland dysfunction without Sjögren disease, inflammation is usually confined to the ocular surface, Akpek said. As a result, symptoms tend to be less severe and progressive.

The results of this small study need validation in a larger cohort, said Steven Carsons, MD, chief of the Division of Rheumatology at NYU Langone Hospital–Long Island, who was not involved with the study. In general, however, noninvasive alternatives to today’s tests for Sjögren disease could be useful for patients and physicians.

“The definitive diagnosis is a minor salivary glandular biopsy, which is invasive and isn’t really appealing to a lot of patients,” Dr. Carsons said. This test can also be difficult to access if patients don’t live near a medical center that specializes in Sjögren disease, he said.

“I think it’s everybody’s goal to have a noninvasive test be able, at some point, to replace biopsy,” Dr. Carsons said.

Then there are blood tests. “The other more objective test, the SSA antibodies, are not very specific for Sjögren’s syndrome,” he said. “They’re fairly sensitive, but can also be seen in other autoimmune conditions, particularly lupus.”

With existing tools, however, optometrists and ophthalmologists can do more to diagnose Sjögren disease early, Dr. Akpek said.

“The issue with Sjögren’s is not that there are no earlier diagnostic aids or anything like that,” Dr. Akpek said.

Lissamine green, a dye that stains degraded cells on the eye’s surface, can reveal clues in young adult patients before other signs. “In my opinion, the earliest clinical finding that indicates presence of the disease is lissamine green staining of conjunctiva,” Akpek said.

Meibomian gland imaging would detect the disease at a later point. “By the time you get meibomian gland dysfunction, there has been longer-standing inflammation,” she said.

Two challenges hold back diagnoses, she said. One is that many practitioners mistakenly believe Sjögren disease is just a nuisance even though it can threaten vision through ocular complications and have more far-reaching effects, too.

“There are a lot of extraglandular systemic manifestations of Sjögren’s that cause morbidity in these patients,” Dr. Akpek said. For example, Sjögren disease is associated with lymphoma and other malignanciesinterstitial nephritisautoimmune hepatitis, and interstitial lung disease with fibrosis.

The second challenge, she said, is that many ophthalmologists and optometrists assume rheumatologists will make the Sjögren disease diagnosis first and then refer patients to them. But eye doctors are well positioned to spot the first signs — if they look for them.

“When you complain of dry eye, unless the doctor puts certain dyes and takes a look at the surface with the dye staining, they can’t see that you are dry,” Dr. Akpek said.

Unfortunately, these tests are underutilized. “I’m sorry to say, dry eye testing, like clinical testing, is not very commonly done,” she said. “Dry eye is managed according to patient symptoms. A lot of the time, Sjögren’s patients have such severe dry eye that they don’t complain of dryness anymore because their corneas become numb.”

Another way to prevent diagnostic delay is to collaborate, communicate, and carefully review patient records shared by other specialists.

“Particularly because of the wide involvement of different organ systems, such as the eyes, the mouth with dental problems, and then systemic features, including joints, it really does need the cooperation of ophthalmologists, dental specialists, and rheumatologists — immunologists sometimes — to come together and make this diagnosis,” Dr. Carsons said.

The study was supported by grants from the National Natural Science Foundation of China. The authors had no relevant disclosures.
 

A version of this article appeared on Medscape.com.

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FROM THERAPEUTIC ADVANCES IN MUSCULOSKELETAL DISEASE

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Does Screening for CKD Benefit Older Adults?

Article Type
Changed
Tue, 10/01/2024 - 06:25

 

TOPLINE:

Short-term mortality, hospitalizations, and cardiovascular disease (CVD) events are not significantly different between patients diagnosed with chronic kidney disease (CKD) during routine medical care and those through screening, in a study that found older age, being male, and having a diagnosis of heart failure are associated with an increased risk for mortality in patients with CKD.

METHODOLOGY:

  • Researchers conducted a prospective cohort study involving 892 primary care patients aged 60 years or older with CKD from the Oxford Renal Cohort Study in England.
  • Participants were categorized into those with existing CKD (n = 257; median age, 75 years), screen-detected CKD (n = 185; median age, roughly 73 years), or temporary reduction in kidney function (n = 450; median age, roughly 73 years).
  • The primary outcome was a composite of all-cause mortality, hospitalization, CVD, or end-stage kidney disease.
  • The secondary outcomes were the individual components of the composite primary outcome and factors associated with mortality in those with CKD.

TAKEAWAY:

  • The composite outcomes were not significantly different between patients with preexisting CKD and kidney disease identified during screening (adjusted hazard ratio [aHR], 0.94; 95% CI, 0.67-1.33).
  • Risks for death, hospitalization, CVD, or end-stage kidney disease were not significantly different between the two groups.
  • Older age (aHR per year, 1.10; 95% CI, 1.06-1.15), male sex (aHR, 2.31; 95% CI, 1.26-4.24), and heart failure (aHR, 5.18; 95% CI, 2.45-10.97) were associated with higher risks for death.
  • No cases of end-stage kidney disease were reported during the study period.

IN PRACTICE:

“Our findings show that the risk of short-term mortality, hospitalization, and CVD is comparable in people diagnosed through screening to those diagnosed routinely in primary care. This suggests that screening older people for CKD may be of value to increase detection and enable disease-modifying treatment to be initiated at an earlier stage,” the study authors wrote.

SOURCE:

The study was led by Anna K. Forbes, MBChB, and José M. Ordóñez-Mena, PhD, of the Nuffield Department of Primary Care Health Sciences at the University of Oxford, England. It was published online in BJGP Open.

LIMITATIONS:

The study had a relatively short follow-up period and a cohort primarily consisting of individuals with early-stage CKD, which may have limited the identification of end-stage cases of the condition. The study population predominantly consisted of White individuals, affecting the generalizability of the results to more diverse populations. Misclassification bias may have occurred due to changes in the kidney function over time.

DISCLOSURES:

The data linkage provided by NHS Digital was supported by funding from the NIHR School of Primary Care Research. Some authors were partly supported by the NIHR Oxford Biomedical Research Centre and NIHR Oxford Thames Valley Applied Research Collaborative. One author reported receiving financial support for attending a conference, while another received consulting fees from various pharmaceutical companies. Another author reported receiving a grant from the Wellcome Trust and payment while working as a presenter for NB Medical and is an unpaid trustee of some charities.

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

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TOPLINE:

Short-term mortality, hospitalizations, and cardiovascular disease (CVD) events are not significantly different between patients diagnosed with chronic kidney disease (CKD) during routine medical care and those through screening, in a study that found older age, being male, and having a diagnosis of heart failure are associated with an increased risk for mortality in patients with CKD.

METHODOLOGY:

  • Researchers conducted a prospective cohort study involving 892 primary care patients aged 60 years or older with CKD from the Oxford Renal Cohort Study in England.
  • Participants were categorized into those with existing CKD (n = 257; median age, 75 years), screen-detected CKD (n = 185; median age, roughly 73 years), or temporary reduction in kidney function (n = 450; median age, roughly 73 years).
  • The primary outcome was a composite of all-cause mortality, hospitalization, CVD, or end-stage kidney disease.
  • The secondary outcomes were the individual components of the composite primary outcome and factors associated with mortality in those with CKD.

TAKEAWAY:

  • The composite outcomes were not significantly different between patients with preexisting CKD and kidney disease identified during screening (adjusted hazard ratio [aHR], 0.94; 95% CI, 0.67-1.33).
  • Risks for death, hospitalization, CVD, or end-stage kidney disease were not significantly different between the two groups.
  • Older age (aHR per year, 1.10; 95% CI, 1.06-1.15), male sex (aHR, 2.31; 95% CI, 1.26-4.24), and heart failure (aHR, 5.18; 95% CI, 2.45-10.97) were associated with higher risks for death.
  • No cases of end-stage kidney disease were reported during the study period.

IN PRACTICE:

“Our findings show that the risk of short-term mortality, hospitalization, and CVD is comparable in people diagnosed through screening to those diagnosed routinely in primary care. This suggests that screening older people for CKD may be of value to increase detection and enable disease-modifying treatment to be initiated at an earlier stage,” the study authors wrote.

SOURCE:

The study was led by Anna K. Forbes, MBChB, and José M. Ordóñez-Mena, PhD, of the Nuffield Department of Primary Care Health Sciences at the University of Oxford, England. It was published online in BJGP Open.

LIMITATIONS:

The study had a relatively short follow-up period and a cohort primarily consisting of individuals with early-stage CKD, which may have limited the identification of end-stage cases of the condition. The study population predominantly consisted of White individuals, affecting the generalizability of the results to more diverse populations. Misclassification bias may have occurred due to changes in the kidney function over time.

DISCLOSURES:

The data linkage provided by NHS Digital was supported by funding from the NIHR School of Primary Care Research. Some authors were partly supported by the NIHR Oxford Biomedical Research Centre and NIHR Oxford Thames Valley Applied Research Collaborative. One author reported receiving financial support for attending a conference, while another received consulting fees from various pharmaceutical companies. Another author reported receiving a grant from the Wellcome Trust and payment while working as a presenter for NB Medical and is an unpaid trustee of some charities.

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

 

TOPLINE:

Short-term mortality, hospitalizations, and cardiovascular disease (CVD) events are not significantly different between patients diagnosed with chronic kidney disease (CKD) during routine medical care and those through screening, in a study that found older age, being male, and having a diagnosis of heart failure are associated with an increased risk for mortality in patients with CKD.

METHODOLOGY:

  • Researchers conducted a prospective cohort study involving 892 primary care patients aged 60 years or older with CKD from the Oxford Renal Cohort Study in England.
  • Participants were categorized into those with existing CKD (n = 257; median age, 75 years), screen-detected CKD (n = 185; median age, roughly 73 years), or temporary reduction in kidney function (n = 450; median age, roughly 73 years).
  • The primary outcome was a composite of all-cause mortality, hospitalization, CVD, or end-stage kidney disease.
  • The secondary outcomes were the individual components of the composite primary outcome and factors associated with mortality in those with CKD.

TAKEAWAY:

  • The composite outcomes were not significantly different between patients with preexisting CKD and kidney disease identified during screening (adjusted hazard ratio [aHR], 0.94; 95% CI, 0.67-1.33).
  • Risks for death, hospitalization, CVD, or end-stage kidney disease were not significantly different between the two groups.
  • Older age (aHR per year, 1.10; 95% CI, 1.06-1.15), male sex (aHR, 2.31; 95% CI, 1.26-4.24), and heart failure (aHR, 5.18; 95% CI, 2.45-10.97) were associated with higher risks for death.
  • No cases of end-stage kidney disease were reported during the study period.

IN PRACTICE:

“Our findings show that the risk of short-term mortality, hospitalization, and CVD is comparable in people diagnosed through screening to those diagnosed routinely in primary care. This suggests that screening older people for CKD may be of value to increase detection and enable disease-modifying treatment to be initiated at an earlier stage,” the study authors wrote.

SOURCE:

The study was led by Anna K. Forbes, MBChB, and José M. Ordóñez-Mena, PhD, of the Nuffield Department of Primary Care Health Sciences at the University of Oxford, England. It was published online in BJGP Open.

LIMITATIONS:

The study had a relatively short follow-up period and a cohort primarily consisting of individuals with early-stage CKD, which may have limited the identification of end-stage cases of the condition. The study population predominantly consisted of White individuals, affecting the generalizability of the results to more diverse populations. Misclassification bias may have occurred due to changes in the kidney function over time.

DISCLOSURES:

The data linkage provided by NHS Digital was supported by funding from the NIHR School of Primary Care Research. Some authors were partly supported by the NIHR Oxford Biomedical Research Centre and NIHR Oxford Thames Valley Applied Research Collaborative. One author reported receiving financial support for attending a conference, while another received consulting fees from various pharmaceutical companies. Another author reported receiving a grant from the Wellcome Trust and payment while working as a presenter for NB Medical and is an unpaid trustee of some charities.

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

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ILD Subtypes in Rheumatoid Arthritis Carry Different Risk Factor Profiles

Article Type
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Fri, 09/27/2024 - 16:06

 

TOPLINE:

Older age, male sex, and seropositivity are linked to a higher risk for rheumatoid arthritis–interstitial lung disease (RA-ILD) with a usual interstitial pneumonia (UIP) pattern, while only seropositivity is associated with RA-ILD with a nonspecific interstitial pneumonia pattern (NSIP).

METHODOLOGY:

  • Researchers conducted a case-control study using data from two cohorts in the Mass General Brigham Healthcare system to examine the risk factors associated with different subtypes of RA-ILD.
  • They identified 208 patients with RA-ILD (mean age at RA diagnosis, 50.7 years; 67.3% women) and 547 control participants with RA but no ILD (mean age at RA diagnosis, 49.1 years; 78.1% women), who had high-resolution computed tomography (HRCT) imaging data available.
  • RA-ILD subtypes such as RA-UIP, RA-NSIP, organizing pneumonia, and others were determined with HRCT scans.
  • The associations between demographics, lifestyle, and serologic factors and RA-ILD subtypes were evaluated using multivariable logistic regression analysis.

TAKEAWAY:

  • The RA-UIP subtype, the one with worst prognosis, was associated with older age during the time of RA diagnosis (odds ratio [OR], 1.03 per year; 95% CI, 1.01-1.05), male sex (OR, 2.15; 95% CI, 1.33-3.48), and seropositivity (OR, 2.08; 95% CI, 1.24-3.48).
  • On the other hand, the RA-NSIP subtype was significantly associated only with seropositivity (OR, 3.21; 95% CI, 1.36-7.56).
  • Nonfibrotic ILDs were significantly associated with positive smoking status (OR, 2.81; 95% CI, 1.52-5.21) and seropositivity (OR, 2.09; 95% CI, 1.19-3.67).
  • The combination of male sex, seropositivity, and positive smoking status was associated with a nearly sevenfold increased risk for RA-UIP (OR, 6.89; 95% CI, 2.41-19.69), compared with having no RA-ILD risk factors.

IN PRACTICE:

“These findings suggest that RA-ILD subtypes may have distinct risk factor profiles and emphasize the importance of further efforts to understand RA-ILD disease heterogeneity to inform screening and prognostication strategies,” the authors wrote.

SOURCE:

The study was led by Gregory C. McDermott, MD, MPH, Brigham and Women’s Hospital, Boston, and was published online on September 11, 2024, in Arthritis Care & Research.

LIMITATIONS:

This study relied on HRCT imaging, which may have introduced selection bias within the control groups. RA disease activity measures were not available for the Mass General Brigham Biobank RA cohort, which limited the analysis of the influence of disease activity on the risk for RA-ILD. Both cohorts predominantly involved White patients, which may have limited the generalizability of the findings to more diverse populations.

DISCLOSURES:

Some authors were supported by the Rheumatology Research Foundation Scientist Development Award, a VERITY Pilot & Feasibility Research Award, the Société Française de Rhumatologie, the National Institute of Arthritis and Musculoskeletal and Skin Diseases, and other sources. The authors declared receiving grant support, consulting fees, and honoraria from various organizations and pharmaceutical companies.

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

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TOPLINE:

Older age, male sex, and seropositivity are linked to a higher risk for rheumatoid arthritis–interstitial lung disease (RA-ILD) with a usual interstitial pneumonia (UIP) pattern, while only seropositivity is associated with RA-ILD with a nonspecific interstitial pneumonia pattern (NSIP).

METHODOLOGY:

  • Researchers conducted a case-control study using data from two cohorts in the Mass General Brigham Healthcare system to examine the risk factors associated with different subtypes of RA-ILD.
  • They identified 208 patients with RA-ILD (mean age at RA diagnosis, 50.7 years; 67.3% women) and 547 control participants with RA but no ILD (mean age at RA diagnosis, 49.1 years; 78.1% women), who had high-resolution computed tomography (HRCT) imaging data available.
  • RA-ILD subtypes such as RA-UIP, RA-NSIP, organizing pneumonia, and others were determined with HRCT scans.
  • The associations between demographics, lifestyle, and serologic factors and RA-ILD subtypes were evaluated using multivariable logistic regression analysis.

TAKEAWAY:

  • The RA-UIP subtype, the one with worst prognosis, was associated with older age during the time of RA diagnosis (odds ratio [OR], 1.03 per year; 95% CI, 1.01-1.05), male sex (OR, 2.15; 95% CI, 1.33-3.48), and seropositivity (OR, 2.08; 95% CI, 1.24-3.48).
  • On the other hand, the RA-NSIP subtype was significantly associated only with seropositivity (OR, 3.21; 95% CI, 1.36-7.56).
  • Nonfibrotic ILDs were significantly associated with positive smoking status (OR, 2.81; 95% CI, 1.52-5.21) and seropositivity (OR, 2.09; 95% CI, 1.19-3.67).
  • The combination of male sex, seropositivity, and positive smoking status was associated with a nearly sevenfold increased risk for RA-UIP (OR, 6.89; 95% CI, 2.41-19.69), compared with having no RA-ILD risk factors.

IN PRACTICE:

“These findings suggest that RA-ILD subtypes may have distinct risk factor profiles and emphasize the importance of further efforts to understand RA-ILD disease heterogeneity to inform screening and prognostication strategies,” the authors wrote.

SOURCE:

The study was led by Gregory C. McDermott, MD, MPH, Brigham and Women’s Hospital, Boston, and was published online on September 11, 2024, in Arthritis Care & Research.

LIMITATIONS:

This study relied on HRCT imaging, which may have introduced selection bias within the control groups. RA disease activity measures were not available for the Mass General Brigham Biobank RA cohort, which limited the analysis of the influence of disease activity on the risk for RA-ILD. Both cohorts predominantly involved White patients, which may have limited the generalizability of the findings to more diverse populations.

DISCLOSURES:

Some authors were supported by the Rheumatology Research Foundation Scientist Development Award, a VERITY Pilot & Feasibility Research Award, the Société Française de Rhumatologie, the National Institute of Arthritis and Musculoskeletal and Skin Diseases, and other sources. The authors declared receiving grant support, consulting fees, and honoraria from various organizations and pharmaceutical companies.

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

 

TOPLINE:

Older age, male sex, and seropositivity are linked to a higher risk for rheumatoid arthritis–interstitial lung disease (RA-ILD) with a usual interstitial pneumonia (UIP) pattern, while only seropositivity is associated with RA-ILD with a nonspecific interstitial pneumonia pattern (NSIP).

METHODOLOGY:

  • Researchers conducted a case-control study using data from two cohorts in the Mass General Brigham Healthcare system to examine the risk factors associated with different subtypes of RA-ILD.
  • They identified 208 patients with RA-ILD (mean age at RA diagnosis, 50.7 years; 67.3% women) and 547 control participants with RA but no ILD (mean age at RA diagnosis, 49.1 years; 78.1% women), who had high-resolution computed tomography (HRCT) imaging data available.
  • RA-ILD subtypes such as RA-UIP, RA-NSIP, organizing pneumonia, and others were determined with HRCT scans.
  • The associations between demographics, lifestyle, and serologic factors and RA-ILD subtypes were evaluated using multivariable logistic regression analysis.

TAKEAWAY:

  • The RA-UIP subtype, the one with worst prognosis, was associated with older age during the time of RA diagnosis (odds ratio [OR], 1.03 per year; 95% CI, 1.01-1.05), male sex (OR, 2.15; 95% CI, 1.33-3.48), and seropositivity (OR, 2.08; 95% CI, 1.24-3.48).
  • On the other hand, the RA-NSIP subtype was significantly associated only with seropositivity (OR, 3.21; 95% CI, 1.36-7.56).
  • Nonfibrotic ILDs were significantly associated with positive smoking status (OR, 2.81; 95% CI, 1.52-5.21) and seropositivity (OR, 2.09; 95% CI, 1.19-3.67).
  • The combination of male sex, seropositivity, and positive smoking status was associated with a nearly sevenfold increased risk for RA-UIP (OR, 6.89; 95% CI, 2.41-19.69), compared with having no RA-ILD risk factors.

IN PRACTICE:

“These findings suggest that RA-ILD subtypes may have distinct risk factor profiles and emphasize the importance of further efforts to understand RA-ILD disease heterogeneity to inform screening and prognostication strategies,” the authors wrote.

SOURCE:

The study was led by Gregory C. McDermott, MD, MPH, Brigham and Women’s Hospital, Boston, and was published online on September 11, 2024, in Arthritis Care & Research.

LIMITATIONS:

This study relied on HRCT imaging, which may have introduced selection bias within the control groups. RA disease activity measures were not available for the Mass General Brigham Biobank RA cohort, which limited the analysis of the influence of disease activity on the risk for RA-ILD. Both cohorts predominantly involved White patients, which may have limited the generalizability of the findings to more diverse populations.

DISCLOSURES:

Some authors were supported by the Rheumatology Research Foundation Scientist Development Award, a VERITY Pilot & Feasibility Research Award, the Société Française de Rhumatologie, the National Institute of Arthritis and Musculoskeletal and Skin Diseases, and other sources. The authors declared receiving grant support, consulting fees, and honoraria from various organizations and pharmaceutical companies.

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

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Cannabis Linked to Bulging Eyes in Graves’ Disease

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Fri, 09/27/2024 - 15:38

 

TOPLINE:

Among patients with autoimmune hyperthyroidism, those who use cannabis are 1.9 times more likely to develop exophthalmos — eyes that appear to bulge from the face — within 1 year of diagnosis, than those who do not use the drug. However, the added risk may wane over time.

METHODOLOGY:

  • Researchers analyzed data from TriNetX, an electronic health record platform, for more than 36,000 patients with autoimmune hyperthyroidism between 2003 and 2023.
  • The dataset included cannabis users (n = 783), nicotine users (n = 17,310), and control individuals (n = 18,093) who did not use either substance.
  • Primary outcomes included presentations of thyroid eye disease (TED) and the use of treatments for the condition, such as teprotumumab, steroids, eyelid retraction repair, tarsorrhaphy, strabismus surgery, or orbital decompression.
  • The investigators used propensity matching to control for characteristics such as age, sex, race, and prior thyroidectomy or radio ablation.

TAKEAWAY:

  • The incidence of exophthalmos at 1 year was 4.1% among nicotine users, 4.1% among cannabis users, and 2.2% among controls.
  • Cannabis users were 1.9 times more likely than controls to develop exophthalmos within 1 year (P = .03).
  • At 2 years, the researchers identified a trend toward more TED in cannabis users than in controls, but the difference was no longer statistically significant.
  • Cannabis users were about 2.5 times more likely than controls to be prescribed steroids throughout the 2-year follow-up period.

IN PRACTICE:

“These findings altogether suggest that cannabis usage may be associated with earlier progression or increased short-term severity of TED symptoms,” the authors of the study wrote. The mechanisms may be like those for cigarette smoking and could include inflammation and vascular congestion, they added.

SOURCE:

The study was conducted by Amanda M. Zong and Anne Barmettler, MD, with Albert Einstein College of Medicine in New York City. It was published online in Ophthalmic Plastic and Reconstructive Surgery.

LIMITATIONS:

The number of cannabis users was relatively small and included only patients who had received a diagnosis of a cannabis-usage disorder prior to the diagnosis of autoimmune hyperthyroidism, the researchers noted. TED lacks a specific International Classification of Diseases–10 code, which necessitated the use of indirect measures. “Furthermore, the mode of administration, duration, and frequency of cannabis and nicotine usage were not available in the dataset used, limiting analysis of degree of association and modifiable risk,” they wrote.

DISCLOSURES:

The researchers disclosed no relevant financial relationships.

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

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TOPLINE:

Among patients with autoimmune hyperthyroidism, those who use cannabis are 1.9 times more likely to develop exophthalmos — eyes that appear to bulge from the face — within 1 year of diagnosis, than those who do not use the drug. However, the added risk may wane over time.

METHODOLOGY:

  • Researchers analyzed data from TriNetX, an electronic health record platform, for more than 36,000 patients with autoimmune hyperthyroidism between 2003 and 2023.
  • The dataset included cannabis users (n = 783), nicotine users (n = 17,310), and control individuals (n = 18,093) who did not use either substance.
  • Primary outcomes included presentations of thyroid eye disease (TED) and the use of treatments for the condition, such as teprotumumab, steroids, eyelid retraction repair, tarsorrhaphy, strabismus surgery, or orbital decompression.
  • The investigators used propensity matching to control for characteristics such as age, sex, race, and prior thyroidectomy or radio ablation.

TAKEAWAY:

  • The incidence of exophthalmos at 1 year was 4.1% among nicotine users, 4.1% among cannabis users, and 2.2% among controls.
  • Cannabis users were 1.9 times more likely than controls to develop exophthalmos within 1 year (P = .03).
  • At 2 years, the researchers identified a trend toward more TED in cannabis users than in controls, but the difference was no longer statistically significant.
  • Cannabis users were about 2.5 times more likely than controls to be prescribed steroids throughout the 2-year follow-up period.

IN PRACTICE:

“These findings altogether suggest that cannabis usage may be associated with earlier progression or increased short-term severity of TED symptoms,” the authors of the study wrote. The mechanisms may be like those for cigarette smoking and could include inflammation and vascular congestion, they added.

SOURCE:

The study was conducted by Amanda M. Zong and Anne Barmettler, MD, with Albert Einstein College of Medicine in New York City. It was published online in Ophthalmic Plastic and Reconstructive Surgery.

LIMITATIONS:

The number of cannabis users was relatively small and included only patients who had received a diagnosis of a cannabis-usage disorder prior to the diagnosis of autoimmune hyperthyroidism, the researchers noted. TED lacks a specific International Classification of Diseases–10 code, which necessitated the use of indirect measures. “Furthermore, the mode of administration, duration, and frequency of cannabis and nicotine usage were not available in the dataset used, limiting analysis of degree of association and modifiable risk,” they wrote.

DISCLOSURES:

The researchers disclosed no relevant financial relationships.

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

 

TOPLINE:

Among patients with autoimmune hyperthyroidism, those who use cannabis are 1.9 times more likely to develop exophthalmos — eyes that appear to bulge from the face — within 1 year of diagnosis, than those who do not use the drug. However, the added risk may wane over time.

METHODOLOGY:

  • Researchers analyzed data from TriNetX, an electronic health record platform, for more than 36,000 patients with autoimmune hyperthyroidism between 2003 and 2023.
  • The dataset included cannabis users (n = 783), nicotine users (n = 17,310), and control individuals (n = 18,093) who did not use either substance.
  • Primary outcomes included presentations of thyroid eye disease (TED) and the use of treatments for the condition, such as teprotumumab, steroids, eyelid retraction repair, tarsorrhaphy, strabismus surgery, or orbital decompression.
  • The investigators used propensity matching to control for characteristics such as age, sex, race, and prior thyroidectomy or radio ablation.

TAKEAWAY:

  • The incidence of exophthalmos at 1 year was 4.1% among nicotine users, 4.1% among cannabis users, and 2.2% among controls.
  • Cannabis users were 1.9 times more likely than controls to develop exophthalmos within 1 year (P = .03).
  • At 2 years, the researchers identified a trend toward more TED in cannabis users than in controls, but the difference was no longer statistically significant.
  • Cannabis users were about 2.5 times more likely than controls to be prescribed steroids throughout the 2-year follow-up period.

IN PRACTICE:

“These findings altogether suggest that cannabis usage may be associated with earlier progression or increased short-term severity of TED symptoms,” the authors of the study wrote. The mechanisms may be like those for cigarette smoking and could include inflammation and vascular congestion, they added.

SOURCE:

The study was conducted by Amanda M. Zong and Anne Barmettler, MD, with Albert Einstein College of Medicine in New York City. It was published online in Ophthalmic Plastic and Reconstructive Surgery.

LIMITATIONS:

The number of cannabis users was relatively small and included only patients who had received a diagnosis of a cannabis-usage disorder prior to the diagnosis of autoimmune hyperthyroidism, the researchers noted. TED lacks a specific International Classification of Diseases–10 code, which necessitated the use of indirect measures. “Furthermore, the mode of administration, duration, and frequency of cannabis and nicotine usage were not available in the dataset used, limiting analysis of degree of association and modifiable risk,” they wrote.

DISCLOSURES:

The researchers disclosed no relevant financial relationships.

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

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First Hike of Medicare Funding for Residencies in 25 Years Aims to Help Shortages

Article Type
Changed
Fri, 09/27/2024 - 14:46

 

Residency programs across the country may have a few more slots for incoming residents due to a recent bump in Medicare funding.

Case in point: The University of Alabama at Birmingham (UAB). The state has one of the top stroke rates in the country, and yet UAB has the only hospital in the state training future doctors to help stroke patients recover. “Our hospital cares for Alabama’s sickest patients, many who need rehabilitation services,” said Craig Hoesley, MD, senior associate dean for medical education, who oversees graduate medical education (GME) or residency programs.

After decades of stagnant support, a recent bump in Medicare funding will allow UAB to add two more physical medicine and rehabilitation residents to the four residencies already receiving such funding.

Medicare also awarded UAB more funding last year to add an addiction medicine fellowship, one of two such training programs in the state for the specialty that helps treat patients fighting addiction.

UAB is among healthcare systems and hospitals nationwide benefiting from a recent hike in Medicare funding for residency programs after some 25 years at the same level of federal support. Medicare is the largest funder of training positions. Otherwise, hospitals finance training through means such as state support.

The latest round of funding, which went into effect in July, adds 200 positions to the doctor pipeline, creating more openings for residents seeking positions after medical school.

In the next few months, the Centers for Medicare & Medicaid Services (CMS) will notify teaching hospitals whether they’ll receive the next round of Medicare funding for more residency positions. At that time, CMS will have awarded nearly half of the 1200 residency training slots Congress approved in the past few years. In 2020 — for the first time since 1996 — Congress approved adding 1000 residency slots at teaching hospitals nationwide. CMS awards the money for 200 slots each year for 5 years.

More than half of the initial round of funding focused on training primary care specialists, with other slots designated for mental health specialists. Last year, Congress also approved a separate allocation of 200 more Medicare-funded residency positions, with at least half designated for psychiatry and related subspecialty residencies to help meet the growing need for more mental health specialists. On August 1, CMS announced it would distribute the funds next year, effective in 2026.

The additional Medicare funding attempts to address the shortage of healthcare providers and ensure future access to care, including in rural and underserved communities. The Association of American Medical Colleges (AAMC) estimates the nation will face a shortage of up to 86,000 physicians by 2036, including primary care doctors and specialists.

In addition, more than 100 million Americans, nearly a third of the nation, don’t have access to primary care due to the physician shortages in their communities, according to the National Association of Community Health Centers.

Major medical organizations, medical schools, and hospital groups have been pushing for years for increased Medicare funding to train new doctors to keep up with the demand for healthcare services and offset the physician shortage. As a cost-saving measure, Medicare set its cap in 1996 for how much it will reimburse each hospital offering GME training. However, according to the medical groups that continue to advocate to Congress for more funding, the funding hasn’t kept pace with the growing healthcare needs or rising medical school enrollment.
 

 

 

Adding Residency Spots

In April, Dr. Hoesley of UAB spoke at a Congressional briefing among health systems and hospitals that benefited from the additional funding. He told Congressional leaders how the increased number of GME positions affects UAB Medicine and its ability to care for rural areas.

“We have entire counties in Alabama that don’t have physicians. One way to address the physician shortage is to grow the GME programs. The funding we received will help us grow these programs and care for residents in our state.”

Still, the Medicare funding is only a drop in the bucket, Dr. Hoesley said. “We rely on Medicare funding alongside other funding partners to train residents and expand our care across the state.” He said many UAB residency programs are over their Medicare funding cap and would like to grow, but they can’t without more funding.

Mount Sinai Health System in New York City also will be able to expand its residency program after receiving Medicare support in the latest round of funding. The health system will use the federal funds to train an additional vascular surgeon. Mount Sinai currently receives CMS funding to train three residents in the specialty.

Over a 5-year program, that means CMS funding will help train 20 residents in the specialty that treats blood vessel blockages and diseases of the veins and arteries generally associated with aging.

“The funding is amazing,” said Peter L. Faries, MD, a surgery professor and system chief of vascular surgery at the Icahn School of Medicine at Mount Sinai, New York City, who directs the residency program.

“We don’t have the capacity to provide an individual training program without the funding. It’s not economically feasible.”

The need for more vascular surgeons increases as the population continues to age, he said. Mount Sinai treats patients throughout New York, including underserved areas in Harlem, the Bronx, Washington Heights, Brooklyn, and Queens. “These individuals might not receive an appropriate level of vascular care if we don’t have clinicians to treat them.”

Of the recent funding, Dr. Faries said it’s taken the residency program 15 years of advocacy to increase by two slots. “It’s a long process to get funding.” Vascular training programs can remain very selective with Medicare funding, typically receiving two applicants for every position,” said Dr. Faries.
 

Pushing for More Funds

Nearly 98,000 students enrolled in medical school this year, according to the National Resident Matching Program. A total of 44,853 applicants vied for the 38,494 first-year residency positions and 3009 second-year slots, leaving 3350 medical school graduates without a match.

“There are not enough spots to meet the growing demand,” said Jesse M. Ehrenfeld, MD, MPH, immediate past president of the American Medical Association. “Graduate medical education funding has not kept up.”

Despite the increase in medical school graduates over the past two decades, Medicare-supported training opportunities remained frozen at the 1996 level. A limited number of training positions meant residency programs couldn’t expand the physician pipeline to offset an aging workforce, contributing to the shortage. “The way to solve this is to expand GME,” Dr. Ehrenfeld said. “We continue to advocate to remove the cap.”

Dr. Ehrenfeld also told this news organization that he doesn’t mind that Congress recently designated GME funding to certain specialties, such as psychiatry, because he believes the need is great for residency spots across the board. “The good news is people recognize it’s challenging to get much through Congress.” He’s optimistic, though, about recent legislative efforts to increase funding.

AAMC, representing about a third of the nation’s 1100 teaching hospitals and health systems, feels the same. Congress “acknowledges and continues to recognize that the shortage is not getting better, and one way to address it is to increase Medicare-supported GME positions,” said Leonard Marquez, senior director of government relations and legislative advocacy.

Still, he said that the Medicare funding bump is only making a small dent in the need. AAMC estimates the average cost to train residents is $23 billion annually, and Medicare only funds 20% of that, or $5 billion. “Our members are at the point where they say: We already can’t add new training positions,” Mr. Marquez said. He added that without increasing residency slots, patient care will suffer. “We have to do anything possible we can to increase access to care.”

Mr. Marquez also believes Medicare funding should increase residency positions across the specialty spectrum, not just for psychiatry and primary care. He said that the targeted funding may prevent some teaching hospitals from applying for residency positions if they need other types of specialists based on their community’s needs.

Among the current proposals before Congress, the Resident Physician Shortage Reduction Act of 2023 would add 14,000 Medicare-supported residency slots over 7 years. Mr. Marquez said it may be more realistic to expect fewer new slots. A decision on potential legislation is expected at the end of the year. He said that if the medical groups aren’t pleased with the decision, they’ll advocate again in 2025.
 

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

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Residency programs across the country may have a few more slots for incoming residents due to a recent bump in Medicare funding.

Case in point: The University of Alabama at Birmingham (UAB). The state has one of the top stroke rates in the country, and yet UAB has the only hospital in the state training future doctors to help stroke patients recover. “Our hospital cares for Alabama’s sickest patients, many who need rehabilitation services,” said Craig Hoesley, MD, senior associate dean for medical education, who oversees graduate medical education (GME) or residency programs.

After decades of stagnant support, a recent bump in Medicare funding will allow UAB to add two more physical medicine and rehabilitation residents to the four residencies already receiving such funding.

Medicare also awarded UAB more funding last year to add an addiction medicine fellowship, one of two such training programs in the state for the specialty that helps treat patients fighting addiction.

UAB is among healthcare systems and hospitals nationwide benefiting from a recent hike in Medicare funding for residency programs after some 25 years at the same level of federal support. Medicare is the largest funder of training positions. Otherwise, hospitals finance training through means such as state support.

The latest round of funding, which went into effect in July, adds 200 positions to the doctor pipeline, creating more openings for residents seeking positions after medical school.

In the next few months, the Centers for Medicare & Medicaid Services (CMS) will notify teaching hospitals whether they’ll receive the next round of Medicare funding for more residency positions. At that time, CMS will have awarded nearly half of the 1200 residency training slots Congress approved in the past few years. In 2020 — for the first time since 1996 — Congress approved adding 1000 residency slots at teaching hospitals nationwide. CMS awards the money for 200 slots each year for 5 years.

More than half of the initial round of funding focused on training primary care specialists, with other slots designated for mental health specialists. Last year, Congress also approved a separate allocation of 200 more Medicare-funded residency positions, with at least half designated for psychiatry and related subspecialty residencies to help meet the growing need for more mental health specialists. On August 1, CMS announced it would distribute the funds next year, effective in 2026.

The additional Medicare funding attempts to address the shortage of healthcare providers and ensure future access to care, including in rural and underserved communities. The Association of American Medical Colleges (AAMC) estimates the nation will face a shortage of up to 86,000 physicians by 2036, including primary care doctors and specialists.

In addition, more than 100 million Americans, nearly a third of the nation, don’t have access to primary care due to the physician shortages in their communities, according to the National Association of Community Health Centers.

Major medical organizations, medical schools, and hospital groups have been pushing for years for increased Medicare funding to train new doctors to keep up with the demand for healthcare services and offset the physician shortage. As a cost-saving measure, Medicare set its cap in 1996 for how much it will reimburse each hospital offering GME training. However, according to the medical groups that continue to advocate to Congress for more funding, the funding hasn’t kept pace with the growing healthcare needs or rising medical school enrollment.
 

 

 

Adding Residency Spots

In April, Dr. Hoesley of UAB spoke at a Congressional briefing among health systems and hospitals that benefited from the additional funding. He told Congressional leaders how the increased number of GME positions affects UAB Medicine and its ability to care for rural areas.

“We have entire counties in Alabama that don’t have physicians. One way to address the physician shortage is to grow the GME programs. The funding we received will help us grow these programs and care for residents in our state.”

Still, the Medicare funding is only a drop in the bucket, Dr. Hoesley said. “We rely on Medicare funding alongside other funding partners to train residents and expand our care across the state.” He said many UAB residency programs are over their Medicare funding cap and would like to grow, but they can’t without more funding.

Mount Sinai Health System in New York City also will be able to expand its residency program after receiving Medicare support in the latest round of funding. The health system will use the federal funds to train an additional vascular surgeon. Mount Sinai currently receives CMS funding to train three residents in the specialty.

Over a 5-year program, that means CMS funding will help train 20 residents in the specialty that treats blood vessel blockages and diseases of the veins and arteries generally associated with aging.

“The funding is amazing,” said Peter L. Faries, MD, a surgery professor and system chief of vascular surgery at the Icahn School of Medicine at Mount Sinai, New York City, who directs the residency program.

“We don’t have the capacity to provide an individual training program without the funding. It’s not economically feasible.”

The need for more vascular surgeons increases as the population continues to age, he said. Mount Sinai treats patients throughout New York, including underserved areas in Harlem, the Bronx, Washington Heights, Brooklyn, and Queens. “These individuals might not receive an appropriate level of vascular care if we don’t have clinicians to treat them.”

Of the recent funding, Dr. Faries said it’s taken the residency program 15 years of advocacy to increase by two slots. “It’s a long process to get funding.” Vascular training programs can remain very selective with Medicare funding, typically receiving two applicants for every position,” said Dr. Faries.
 

Pushing for More Funds

Nearly 98,000 students enrolled in medical school this year, according to the National Resident Matching Program. A total of 44,853 applicants vied for the 38,494 first-year residency positions and 3009 second-year slots, leaving 3350 medical school graduates without a match.

“There are not enough spots to meet the growing demand,” said Jesse M. Ehrenfeld, MD, MPH, immediate past president of the American Medical Association. “Graduate medical education funding has not kept up.”

Despite the increase in medical school graduates over the past two decades, Medicare-supported training opportunities remained frozen at the 1996 level. A limited number of training positions meant residency programs couldn’t expand the physician pipeline to offset an aging workforce, contributing to the shortage. “The way to solve this is to expand GME,” Dr. Ehrenfeld said. “We continue to advocate to remove the cap.”

Dr. Ehrenfeld also told this news organization that he doesn’t mind that Congress recently designated GME funding to certain specialties, such as psychiatry, because he believes the need is great for residency spots across the board. “The good news is people recognize it’s challenging to get much through Congress.” He’s optimistic, though, about recent legislative efforts to increase funding.

AAMC, representing about a third of the nation’s 1100 teaching hospitals and health systems, feels the same. Congress “acknowledges and continues to recognize that the shortage is not getting better, and one way to address it is to increase Medicare-supported GME positions,” said Leonard Marquez, senior director of government relations and legislative advocacy.

Still, he said that the Medicare funding bump is only making a small dent in the need. AAMC estimates the average cost to train residents is $23 billion annually, and Medicare only funds 20% of that, or $5 billion. “Our members are at the point where they say: We already can’t add new training positions,” Mr. Marquez said. He added that without increasing residency slots, patient care will suffer. “We have to do anything possible we can to increase access to care.”

Mr. Marquez also believes Medicare funding should increase residency positions across the specialty spectrum, not just for psychiatry and primary care. He said that the targeted funding may prevent some teaching hospitals from applying for residency positions if they need other types of specialists based on their community’s needs.

Among the current proposals before Congress, the Resident Physician Shortage Reduction Act of 2023 would add 14,000 Medicare-supported residency slots over 7 years. Mr. Marquez said it may be more realistic to expect fewer new slots. A decision on potential legislation is expected at the end of the year. He said that if the medical groups aren’t pleased with the decision, they’ll advocate again in 2025.
 

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

 

Residency programs across the country may have a few more slots for incoming residents due to a recent bump in Medicare funding.

Case in point: The University of Alabama at Birmingham (UAB). The state has one of the top stroke rates in the country, and yet UAB has the only hospital in the state training future doctors to help stroke patients recover. “Our hospital cares for Alabama’s sickest patients, many who need rehabilitation services,” said Craig Hoesley, MD, senior associate dean for medical education, who oversees graduate medical education (GME) or residency programs.

After decades of stagnant support, a recent bump in Medicare funding will allow UAB to add two more physical medicine and rehabilitation residents to the four residencies already receiving such funding.

Medicare also awarded UAB more funding last year to add an addiction medicine fellowship, one of two such training programs in the state for the specialty that helps treat patients fighting addiction.

UAB is among healthcare systems and hospitals nationwide benefiting from a recent hike in Medicare funding for residency programs after some 25 years at the same level of federal support. Medicare is the largest funder of training positions. Otherwise, hospitals finance training through means such as state support.

The latest round of funding, which went into effect in July, adds 200 positions to the doctor pipeline, creating more openings for residents seeking positions after medical school.

In the next few months, the Centers for Medicare & Medicaid Services (CMS) will notify teaching hospitals whether they’ll receive the next round of Medicare funding for more residency positions. At that time, CMS will have awarded nearly half of the 1200 residency training slots Congress approved in the past few years. In 2020 — for the first time since 1996 — Congress approved adding 1000 residency slots at teaching hospitals nationwide. CMS awards the money for 200 slots each year for 5 years.

More than half of the initial round of funding focused on training primary care specialists, with other slots designated for mental health specialists. Last year, Congress also approved a separate allocation of 200 more Medicare-funded residency positions, with at least half designated for psychiatry and related subspecialty residencies to help meet the growing need for more mental health specialists. On August 1, CMS announced it would distribute the funds next year, effective in 2026.

The additional Medicare funding attempts to address the shortage of healthcare providers and ensure future access to care, including in rural and underserved communities. The Association of American Medical Colleges (AAMC) estimates the nation will face a shortage of up to 86,000 physicians by 2036, including primary care doctors and specialists.

In addition, more than 100 million Americans, nearly a third of the nation, don’t have access to primary care due to the physician shortages in their communities, according to the National Association of Community Health Centers.

Major medical organizations, medical schools, and hospital groups have been pushing for years for increased Medicare funding to train new doctors to keep up with the demand for healthcare services and offset the physician shortage. As a cost-saving measure, Medicare set its cap in 1996 for how much it will reimburse each hospital offering GME training. However, according to the medical groups that continue to advocate to Congress for more funding, the funding hasn’t kept pace with the growing healthcare needs or rising medical school enrollment.
 

 

 

Adding Residency Spots

In April, Dr. Hoesley of UAB spoke at a Congressional briefing among health systems and hospitals that benefited from the additional funding. He told Congressional leaders how the increased number of GME positions affects UAB Medicine and its ability to care for rural areas.

“We have entire counties in Alabama that don’t have physicians. One way to address the physician shortage is to grow the GME programs. The funding we received will help us grow these programs and care for residents in our state.”

Still, the Medicare funding is only a drop in the bucket, Dr. Hoesley said. “We rely on Medicare funding alongside other funding partners to train residents and expand our care across the state.” He said many UAB residency programs are over their Medicare funding cap and would like to grow, but they can’t without more funding.

Mount Sinai Health System in New York City also will be able to expand its residency program after receiving Medicare support in the latest round of funding. The health system will use the federal funds to train an additional vascular surgeon. Mount Sinai currently receives CMS funding to train three residents in the specialty.

Over a 5-year program, that means CMS funding will help train 20 residents in the specialty that treats blood vessel blockages and diseases of the veins and arteries generally associated with aging.

“The funding is amazing,” said Peter L. Faries, MD, a surgery professor and system chief of vascular surgery at the Icahn School of Medicine at Mount Sinai, New York City, who directs the residency program.

“We don’t have the capacity to provide an individual training program without the funding. It’s not economically feasible.”

The need for more vascular surgeons increases as the population continues to age, he said. Mount Sinai treats patients throughout New York, including underserved areas in Harlem, the Bronx, Washington Heights, Brooklyn, and Queens. “These individuals might not receive an appropriate level of vascular care if we don’t have clinicians to treat them.”

Of the recent funding, Dr. Faries said it’s taken the residency program 15 years of advocacy to increase by two slots. “It’s a long process to get funding.” Vascular training programs can remain very selective with Medicare funding, typically receiving two applicants for every position,” said Dr. Faries.
 

Pushing for More Funds

Nearly 98,000 students enrolled in medical school this year, according to the National Resident Matching Program. A total of 44,853 applicants vied for the 38,494 first-year residency positions and 3009 second-year slots, leaving 3350 medical school graduates without a match.

“There are not enough spots to meet the growing demand,” said Jesse M. Ehrenfeld, MD, MPH, immediate past president of the American Medical Association. “Graduate medical education funding has not kept up.”

Despite the increase in medical school graduates over the past two decades, Medicare-supported training opportunities remained frozen at the 1996 level. A limited number of training positions meant residency programs couldn’t expand the physician pipeline to offset an aging workforce, contributing to the shortage. “The way to solve this is to expand GME,” Dr. Ehrenfeld said. “We continue to advocate to remove the cap.”

Dr. Ehrenfeld also told this news organization that he doesn’t mind that Congress recently designated GME funding to certain specialties, such as psychiatry, because he believes the need is great for residency spots across the board. “The good news is people recognize it’s challenging to get much through Congress.” He’s optimistic, though, about recent legislative efforts to increase funding.

AAMC, representing about a third of the nation’s 1100 teaching hospitals and health systems, feels the same. Congress “acknowledges and continues to recognize that the shortage is not getting better, and one way to address it is to increase Medicare-supported GME positions,” said Leonard Marquez, senior director of government relations and legislative advocacy.

Still, he said that the Medicare funding bump is only making a small dent in the need. AAMC estimates the average cost to train residents is $23 billion annually, and Medicare only funds 20% of that, or $5 billion. “Our members are at the point where they say: We already can’t add new training positions,” Mr. Marquez said. He added that without increasing residency slots, patient care will suffer. “We have to do anything possible we can to increase access to care.”

Mr. Marquez also believes Medicare funding should increase residency positions across the specialty spectrum, not just for psychiatry and primary care. He said that the targeted funding may prevent some teaching hospitals from applying for residency positions if they need other types of specialists based on their community’s needs.

Among the current proposals before Congress, the Resident Physician Shortage Reduction Act of 2023 would add 14,000 Medicare-supported residency slots over 7 years. Mr. Marquez said it may be more realistic to expect fewer new slots. A decision on potential legislation is expected at the end of the year. He said that if the medical groups aren’t pleased with the decision, they’ll advocate again in 2025.
 

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

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Direct-to-Consumer Testing’s Expansion to Rheumatology Has Benefits but Potential Risks

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Sun, 09/29/2024 - 22:58

 

When Jennifer Welsh, a 40-year-old from New Britain, Connecticut, visited her doctor about pain in her joints and neck, her doctor sent her to the emergency department (ED) to rule out meningitis. The ED did rule that out, as well as strep, so Ms. Welsh went to her follow-up appointment a few days later, hoping for answers or at least more tests to get those answers.

Instead, the doctor — a different one from the same practice as her primary care physician (PCP) — wouldn’t even talk to Ms. Welsh about her symptoms because she couldn’t see the ED’s results and refused to view the results that Ms. Welsh could pull up online.

“She just completely shut me down,” Ms. Welsh recalled. “It was a really awful appointment, and I left in tears. I was in physical pain, I had just been to the ER, nothing is really resolved, I’m stressed out about it, and this woman is completely dismissing me.”

She had been able to schedule an appointment with her regular PCP later that week, but after the harrowing experience with this doctor, she wondered if her PCP would order the rheumatoid arthritis (RA) test that Ms. Welsh suspected she needed. So, she took matters into her own hands.

“I was searching for what test to ask for from my doctor,” she said, and she found that she could order it on her own from a major lab company she was already familiar with. For around $100, “I could get it done and see what it says on my own,” she said.

But that’s not how it worked out. Her regular PCP apologized for the other doctor’s behavior and ordered the RA test as well as additional tests — and got results while Ms. Welsh still waited for the one she ordered to arrive over a week later.

At first, Ms. Welsh was grateful she could order the RA test without her doctor’s referral. “I felt it gave me a sense of control over the situation that I felt really not in control of, until the system failed me, and I didn’t get the results,” she said. But then, “not having someone I could call and get an answer about why my tests were delayed, why I wasn’t able to access them, why it was taking so long — it was definitely anxiety-inducing.”
 

A Growing Market

Ms. Welsh is one of a growing number of patients who are ordering direct-to-consumer (DTC) lab tests without the recommendation or guidance of a doctor. They’re offered online by labs ranging from well-established giants like Quest and Labcorp to smaller, potentially less vetted companies, although some smaller companies contract with larger companies like Quest. Combined, the DTC market is projected to be worth $2 billion by 2025.

Yet the burgeoning industry has also drawn critiques from both bioethicists and privacy experts. A research letter in JAMA in 2023, for example, found that less than half of the 21 companies identified in an online search declared Health Insurance Portability and Accountability Act compliance, while more than half “indicated the potential use of consumer data for research purposes either internally or through third-party sharing.” That study found the most commonly offered tests were related to diabetes, the thyroid, and vitamin levels, and hormone tests for men and women, such as testosterone or estradiol.

But a number of companies also offer tests related to rheumatologic conditions. A handful of tests offered by Labcorp, for example, could be used in rheumatology, such as tests for celiac antibodies or high-sensitivity C-reactive protein. Quest similarly offers a handful of autoimmune-related tests. But other companies offer a long slate of autoimmune or antibody tests.

The antinuclear antibody (ANA) test and RA panel offered by Quest are the same tests, run and analyzed in the same labs, as those ordered by physicians and hospitals, according to James Faix, MD, the medical director of immunology at Quest Diagnostics. Their RA panel includes rheumatoid factor and anti-cyclic citrullinated peptide as well as antibody to mutated citrullinated vimentin, “which may detect approximately 10%-15%” of patients who test negative to the first two.

Quest’s ANA test with reflex costs $112, and its RA panel costs $110, price points that are similar across other companies’ offerings. Labcorp declined to respond to questions about its DTC tests, and several smaller companies did not respond to queries about their offerings. It can therefore be hard to assess what’s included or what the quality is of many DTC tests, particularly from smaller, less established companies.
 

 

 

Oversight and Quality Control

Anthony Killeen, MD, PhD, president of the Association for Diagnostics & Laboratory Medicine (ADLM) and director of Clinical Laboratories at the University of Minnesota Medical Center in Minneapolis, said via email that the ADLM supports “expanding consumer access to direct-to-consumer laboratory testing services that have demonstrated analytical and clinical validity and clinical utility,” given the importance of individuals learning about their health status and becoming more involved in health decisions. But the ADLM also recommends “that only CLIA-certified laboratories perform direct-to-consumer testing,” he said.

Dr. Anthony Killeen, president of the Association for Diagnostics & Laboratory Medicine (ADLM) and director of Clinical Laboratories at the University of Minnesota Medical Center in Minneapolis
Association for Diagnostics & Laboratory Medicine
Dr. Anthony Killeen

“There are direct-to-consumer tests on the market that are not medical-grade laboratory tests and that may be performed in nonaccredited laboratories,” Dr. Killeen said. “We advise consumers to steer clear of such tests.” The ADLM also encourages consumers to “work with qualified healthcare providers when making decisions based off the results they receive from any direct-to-consumer tests” and recommends that DTC test companies “provide consumers with sufficient information and/or access to expert help to assist them in ordering tests and interpreting the results.”

Yet it’s unclear how much support, if any, consumers can receive in terms of understanding what their tests mean. Most of the companies in the 2023 study offered optional follow-up with a healthcare professional, but these professionals ranged from physicians to “health coaches,” and all the companies had disclaimers that “test results did not constitute medical advice.”

At Quest, the only company to respond to this news organization’s request for comment, consumer-initiated tests ordered online are first reviewed by a physician at PWNHealth, an independent, third-party physician network, to determine that it’s appropriate before the lab order is actually placed.

“Once results are available, individuals have the option to discuss their results with an independent physician at no extra cost,” Dr. Faix said. ANA or RA results outside the normal ranges may trigger a “call from a PWNHealth healthcare coordinator, who can help provide information, suggestions on next steps, and set up time for the individual to speak with an independent physician to discuss questions or concerns regarding the results,” he said.

“Our goal is not to replace the role of a healthcare provider,” Dr. Faix said. “We are providing an alternate way for people to engage with the healthcare system that offers convenience, gives people more control over their own healthcare journeys, and meets them where they are, supporting both consumers and their care teams.” The company has expanded its offerings from an initial 30 tests made available in 2018 to over 130 today, deciding which to offer “based on consumer research and expertise of clinical experts.” The company has also “seen steady interest in our two consumer rheumatology offerings,” Dr. Faix said.
 

The DTC Landscape in Rheumatology

Within rheumatology, among the most popular tests is for ANA, based on the experience of Alfred Kim, MD, PhD, associate professor of medicine at Washington University School of Medicine in St Louis, Missouri.

Dr. Alfred Kim, director of the Washington University Lupus Clinic
Dr. Kim
Dr. Alfred Kim

 

 

“For a lot of people, losing control over their health is maybe the most frightening experience they can have, so I think a lot of patients use this as a way to kind of have ownership over their health,” Dr. Kim said. “Let’s say they’ve been to four doctors. No one can explain what’s going on. They’re getting frustrated, and so they just turn to solutions where they feel like they have ownership over the situation.”

Though the market is undoubtedly growing, the growth appears uneven across geography and institution types. Kim has seen a “fair number of referrals,” with patients coming in with results from a DTC test. Michael Putman, MD, MSci, assistant professor of medicine at the Medical College of Wisconsin in Milwaukee, hasn’t seen it much. “I know that patients can get testing done themselves independently, but I don’t have people routinely coming in with tests they’ve ordered in advance of our appointment,” Dr. Putman said, but, like Dr. Kim, he recognizes why patients might seek them out.

Dr. Michael Putman, an assistant professor of medicine at the Medical College of Wisconsin in Milwaukee, Wisconsin
Dr. Putman
Dr. Michael Putman


“I’m a big fan of patient empowerment, and I do think that medicine serves a gatekeeper role that sometimes can be a little too far,” Dr. Putman said. “I think there is value to patients being able to get more information and try to understand what is happening in their bodies. I have a lot of compassion for someone who would try to find testing outside of the normal channels.”

Indeed, bringing these test results to a visit could be informative in some scenarios. A negative ANA test, for example, pretty much excludes lupus 100%, Dr. Kim said. But a positive ANA doesn’t tell him much, and if his clinical suspicion for a condition is high, he likely would order that test anyway, even if the patient came in with their own results. Dr. Putman also pointed out that the vast majority of tests used in rheumatology have a high rate of false positives.

“I think that will be the major area where this causes quite a lot of grief to patients and some frustration to some providers,” he said. A rheumatoid factor test like the one Ms. Welsh ordered, for example, might test positive in 10 out of 100 people randomly gathered in a room, but the majority of those individuals would not have RA, he said.

That test is another popular rheumatology one, according to Timothy Niewold, MD, vice chair for research in the Hospital for Special Surgery Department of Medicine in New York City. Among the possible reasons people might order these tests are the delay in diagnosis that can often occur with a lot of rheumatologic conditions and that “it can take a while to see a rheumatologist, depending on what part of the country you’re in and what the availability is,” he said. He’s not surprised to see tests for Sjögren disease among the offerings, for example, because it’s a condition that’s difficult to diagnose but reasonably common within autoimmune diseases.

Dr. Timothy Niewold, vice chair for research in the Hospital for Special Surgery Department of Medicine in New York City
Ron Hester Photography
Dr. Timothy Niewold

 

 

 

Risks vs Benefits

DTC testing is not an answer to the national shortage of rheumatologists, however, especially given the risks that Dr. Niewold, Dr. Putman, and Dr. Kim worry outweigh potential benefits. On the one hand, getting online test results may help expedite a referral to a specialist, Dr. Niewold said. But a long wait for that appointment could then easily become a bigger source of anxiety than comfort, Dr. Putman said.

“It’s a trade-off where you are accepting a lot more people getting false-positive diagnoses and spending months thinking they have some disease where they might not, in exchange for a couple people who would have had a delayed diagnosis,” Dr. Putman said. “There’s an enormous amount of existential suffering,” that’s familiar to rheumatologists because some patients may dread the diagnosis of a rheumatic disease the way they might fear a cancer diagnosis, especially if they have lost a family member to a condition that they suspect they share, he said. “To put yourself into an existential catastrophe — that’s not a small harm.”

Dr. Niewold agreed, pointing out that patients with a positive ANA test may “get unnecessarily worried and stay up all night reading about lupus, getting scared for weeks on end before seeing a specialist.” And there are financial harms as well for patients who may order the same test multiple times, or a whole slate of tests, that they don’t need for hundreds or thousands of dollars. There’s also the lost time and effort of researching a condition or even seeking out support groups that patients may pursue, Dr. Niewold said.

The likely biggest risk to individuals, however, is the potential for overdiagnosis or misdiagnosis.

“If someone comes in and they’ve read the textbook on lupus and they have a positive ANA, it’s really hard as a rheumatologist to walk that back,” Dr. Putman said. “The human mind is a powerful thing,” he added, and people who get a positive test will likely start to notice things like joint pain or a rash on their cheeks and begin attributing it to a diagnosis they risk convincing themselves they have. “When people come into your clinic not knowing what a disease would look like and they just tell you how they’re feeling, it’s a much cleaner and more honest way to approach diagnosis.”

Most patients likely don’t realize, for example, that none of the tests rheumatologists usually order are diagnostic in and of themselves, Dr. Niewold said. “They’re all kind of like stars in the constellation of a diagnosis,” he said. “They’re helpful, but none of them is sufficient by itself.”

Dr. Killeen agreed, noting that “consumers might not understand the nuances of these tests well enough to know whether it is appropriate to order them or how to interpret the results correctly.” Given the long-term implications of a diagnosis for a rheumatologic disease, “I would have concerns about consumers ordering and interpreting rheumatologic tests without working closely with their physicians,” Dr. Killeen said. “The main concern that lab experts have about direct-to-consumer tests is the potential for people to get misleading results and/or to misinterpret their results, which in turn could lead to people not getting the treatment they need or getting treatment when they don’t need any at all.”

It’s one thing for patients to come in asking for a particular treatment they may not need but which a doctor may be able to dissuade them from seeking. But Dr. Kim also pointed out the risk that patients may decide to treat themselves with therapies that haven’t undergone rigorous testing or haven’t been recommended by a physician.

“We tend to have people who come in with a pretty clear idea of what they want done, but the problem is, we don’t know if their reasoning is correct from a clinical perspective,” Dr. Kim said. Companies offer these tests with the belief that they’re “providing patients a choice, an option to take ownership,” he said, “but the potential harm can be realized very quickly because there are going to be people who are misdiagnosing themselves and, worse yet, may then pursue their own treatment plan that’s going in the opposite direction of where we think it needs to go.”

Or, on the flip side, if a patient erroneously believes they have the answer to what ails them, it may delay diagnosis of a more serious condition that’s rarer or harder to detect. Kim pointed to, for example, intravascular lymphoma, which is notoriously as difficult to identify as it is rare and aggressive. If a patient’s confirmation bias has led them to believe they have an autoimmune condition, they may not receive the more serious diagnosis until it’s advanced too far to treat.
 

 

 

Patient-Provider Relationship Friction

Another concern is how these tests may lead to confusion and frustration that can erode the patient-provider relationship, particularly because most patients don’t know how to interpret the results or understand the bigger context in which the results have to be interpreted. Many patients may think a test can come back with a binary answer, a positive or negative, and that means they do or don’t have a condition. That’s generally true for pregnancy tests, COVID tests, and sexually transmitted infection tests — the kinds of tests that have long been available to consumers and which have fairly straightforward answers.

But physicians know that’s not the case for many conditions, particularly those in rheumatology.

“In rheumatic diseases, because the tests have such marginal value in terms of diagnosis, almost always we develop a suspicion before we even think about ordering the tests, and then that dictates whether or not we cross that threshold,” Dr. Kim said. “A negative test doesn’t exclude the fact that you may have disease X, but a positive test also doesn’t mean you have disease X. All they provide is an idea of the risk.”

But some patients who come in with DTC test results have “already made the decision in their mind that they have a certain condition,” Dr. Kim said. “This is obviously dangerous because the majority of these patients do not have the condition they think they have, and it leaves a very uncomfortable feeling after the visit because they feel like they’ve been either betrayed by me or by the test, and they leave more confused.”

Patients may also come in with tests that a doctor isn’t familiar with or isn’t sure how to interpret on its own, at least for that particular patient.

“For ANA testing, we have a pretty good idea of its positive and negative predictive value because it’s ordered so much, but for many of these tests being offered, there are specific autoantibodies, and we tend to only get them in people where there’s a clinical suspicion,” Dr. Kim said. “Within that very specific context, we kind of understand what that value means, but if you give it to the general public, then those numbers aren’t as applicable and most likely overestimate the risk of disease.”

Even if providers consider the results of a DTC test in their differential, they may want to be sure it’s from a trustworthy source. “If a provider is uncertain about whether a direct-to-consumer testing company is reputable or about whether a direct-to-consumer test result is reliable, I would encourage them to consult with their laboratory medicine colleagues,” Dr. Killeen said.
 

Responding to Patients

Like any other patient coming to a clinical visit, the most common reason patients are likely ordering these tests is that they’re seeking answers. Kim doesn’t typically see patients doing their own monitoring for diagnosed conditions between visits — the expense would add up too quickly — or testing for genetic markers, which likely wouldn’t be very helpful either.

 

 

“Even though most of our diseases probably have a genetic underpinning, how much it contributes is always unclear,” Dr. Kim said. Even conditions with clear genetic variants, such as familial Mediterranean fever, spondyloarthritis, and Behçet disease, can only support a diagnosis, not diagnose it on its own, Dr. Killeen said. And these are not among the tests currently available on most DTC company sites.

While there are also tests that can offer information about genetic risks for certain medications, such as a thiopurine methyltransferase test to find out if a patient lacks the enzyme needed to break down the immunosuppressant drug azathioprine, Kim hasn’t seen patients seeking these out either.

“The more global and more compassionate way to think about this is that we have a lot of people who are struggling to understand what’s going on with their bodies, and most physicians really don’t know what the next steps are for these people,” Dr. Kim said. “They’re desperate, and their quality of life is so poor that they’re going to take extreme steps to try to manage their own frustration with this condition.”

That means clinicians’ most powerful tools when patients come in with DTC test results are their listening skills.

“Empathy is the most important thing, just being able to share the patient’s frustration to the point where they had to take matters into their own hands,” Dr. Kim said. “I think a lot of rheumatologists are actually pretty comfortable being in this position.”

Additionally, doctors should know that some patients may be engaging in attempts to self-diagnose, self-treat, or otherwise self-manage their symptoms or perceived condition. “They just need to be aware and try to make sure there’s no harm being done,” Dr. Kim said.

Ms. Welsh didn’t seek treatment or diagnosis on her own, but getting her test also did not give her the control she was seeking. “Looking back, it was kind of a waste of money, but it felt good in the moment,” Ms. Welsh said. “I was so upset, and I wanted that control, and in the end, it didn’t get me results any sooner, and it didn’t give me peace of mind.”

It was Ms. Welsh’s primary care doctor listening to her concerns, ordering the same test she had ordered with several others, and working with her to seek answers that reassured her that her provider cared about her well-being.

“A lot of what I do in my business is reassure people that you know what they have is treatable or not going to end their life as they know it,” Dr. Putman said. “And you certainly can’t reassure them if they’re not in your clinic yet.”

Dr. Putman has participated in clinical trials with AbbVie, consulting with Novartis and GSK, and clinical trials and consulting with Amgen and AstraZeneca. Dr. Niewold reported receiving research grants from EMD Serono and Zenas BioPharma and consulting for Thermo Fisher Scientific, Progentec Diagnostics, Roivant Sciences, AstraZeneca, S3 Connected Health, Flagship Pioneering, and Guidepoint. Dr. Kim reported sponsored research agreements with AstraZeneca, Bristol-Myers Squibb, Novartis, and CRISPR Therapeutics; royalties from Kypha; and consulting/speaking for Amgen, ANI Pharmaceuticals, Atara Biotherapeutics, Aurinia Pharmaceuticals, CARGO Therapeutics, Exagen Diagnostics, GSK, Hinge Bio, Kypha, Progentec Diagnostics, Synthekine, and UpToDate. Dr. Killeen had no relevant financial relationships to disclose.
 

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

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When Jennifer Welsh, a 40-year-old from New Britain, Connecticut, visited her doctor about pain in her joints and neck, her doctor sent her to the emergency department (ED) to rule out meningitis. The ED did rule that out, as well as strep, so Ms. Welsh went to her follow-up appointment a few days later, hoping for answers or at least more tests to get those answers.

Instead, the doctor — a different one from the same practice as her primary care physician (PCP) — wouldn’t even talk to Ms. Welsh about her symptoms because she couldn’t see the ED’s results and refused to view the results that Ms. Welsh could pull up online.

“She just completely shut me down,” Ms. Welsh recalled. “It was a really awful appointment, and I left in tears. I was in physical pain, I had just been to the ER, nothing is really resolved, I’m stressed out about it, and this woman is completely dismissing me.”

She had been able to schedule an appointment with her regular PCP later that week, but after the harrowing experience with this doctor, she wondered if her PCP would order the rheumatoid arthritis (RA) test that Ms. Welsh suspected she needed. So, she took matters into her own hands.

“I was searching for what test to ask for from my doctor,” she said, and she found that she could order it on her own from a major lab company she was already familiar with. For around $100, “I could get it done and see what it says on my own,” she said.

But that’s not how it worked out. Her regular PCP apologized for the other doctor’s behavior and ordered the RA test as well as additional tests — and got results while Ms. Welsh still waited for the one she ordered to arrive over a week later.

At first, Ms. Welsh was grateful she could order the RA test without her doctor’s referral. “I felt it gave me a sense of control over the situation that I felt really not in control of, until the system failed me, and I didn’t get the results,” she said. But then, “not having someone I could call and get an answer about why my tests were delayed, why I wasn’t able to access them, why it was taking so long — it was definitely anxiety-inducing.”
 

A Growing Market

Ms. Welsh is one of a growing number of patients who are ordering direct-to-consumer (DTC) lab tests without the recommendation or guidance of a doctor. They’re offered online by labs ranging from well-established giants like Quest and Labcorp to smaller, potentially less vetted companies, although some smaller companies contract with larger companies like Quest. Combined, the DTC market is projected to be worth $2 billion by 2025.

Yet the burgeoning industry has also drawn critiques from both bioethicists and privacy experts. A research letter in JAMA in 2023, for example, found that less than half of the 21 companies identified in an online search declared Health Insurance Portability and Accountability Act compliance, while more than half “indicated the potential use of consumer data for research purposes either internally or through third-party sharing.” That study found the most commonly offered tests were related to diabetes, the thyroid, and vitamin levels, and hormone tests for men and women, such as testosterone or estradiol.

But a number of companies also offer tests related to rheumatologic conditions. A handful of tests offered by Labcorp, for example, could be used in rheumatology, such as tests for celiac antibodies or high-sensitivity C-reactive protein. Quest similarly offers a handful of autoimmune-related tests. But other companies offer a long slate of autoimmune or antibody tests.

The antinuclear antibody (ANA) test and RA panel offered by Quest are the same tests, run and analyzed in the same labs, as those ordered by physicians and hospitals, according to James Faix, MD, the medical director of immunology at Quest Diagnostics. Their RA panel includes rheumatoid factor and anti-cyclic citrullinated peptide as well as antibody to mutated citrullinated vimentin, “which may detect approximately 10%-15%” of patients who test negative to the first two.

Quest’s ANA test with reflex costs $112, and its RA panel costs $110, price points that are similar across other companies’ offerings. Labcorp declined to respond to questions about its DTC tests, and several smaller companies did not respond to queries about their offerings. It can therefore be hard to assess what’s included or what the quality is of many DTC tests, particularly from smaller, less established companies.
 

 

 

Oversight and Quality Control

Anthony Killeen, MD, PhD, president of the Association for Diagnostics & Laboratory Medicine (ADLM) and director of Clinical Laboratories at the University of Minnesota Medical Center in Minneapolis, said via email that the ADLM supports “expanding consumer access to direct-to-consumer laboratory testing services that have demonstrated analytical and clinical validity and clinical utility,” given the importance of individuals learning about their health status and becoming more involved in health decisions. But the ADLM also recommends “that only CLIA-certified laboratories perform direct-to-consumer testing,” he said.

Dr. Anthony Killeen, president of the Association for Diagnostics & Laboratory Medicine (ADLM) and director of Clinical Laboratories at the University of Minnesota Medical Center in Minneapolis
Association for Diagnostics & Laboratory Medicine
Dr. Anthony Killeen

“There are direct-to-consumer tests on the market that are not medical-grade laboratory tests and that may be performed in nonaccredited laboratories,” Dr. Killeen said. “We advise consumers to steer clear of such tests.” The ADLM also encourages consumers to “work with qualified healthcare providers when making decisions based off the results they receive from any direct-to-consumer tests” and recommends that DTC test companies “provide consumers with sufficient information and/or access to expert help to assist them in ordering tests and interpreting the results.”

Yet it’s unclear how much support, if any, consumers can receive in terms of understanding what their tests mean. Most of the companies in the 2023 study offered optional follow-up with a healthcare professional, but these professionals ranged from physicians to “health coaches,” and all the companies had disclaimers that “test results did not constitute medical advice.”

At Quest, the only company to respond to this news organization’s request for comment, consumer-initiated tests ordered online are first reviewed by a physician at PWNHealth, an independent, third-party physician network, to determine that it’s appropriate before the lab order is actually placed.

“Once results are available, individuals have the option to discuss their results with an independent physician at no extra cost,” Dr. Faix said. ANA or RA results outside the normal ranges may trigger a “call from a PWNHealth healthcare coordinator, who can help provide information, suggestions on next steps, and set up time for the individual to speak with an independent physician to discuss questions or concerns regarding the results,” he said.

“Our goal is not to replace the role of a healthcare provider,” Dr. Faix said. “We are providing an alternate way for people to engage with the healthcare system that offers convenience, gives people more control over their own healthcare journeys, and meets them where they are, supporting both consumers and their care teams.” The company has expanded its offerings from an initial 30 tests made available in 2018 to over 130 today, deciding which to offer “based on consumer research and expertise of clinical experts.” The company has also “seen steady interest in our two consumer rheumatology offerings,” Dr. Faix said.
 

The DTC Landscape in Rheumatology

Within rheumatology, among the most popular tests is for ANA, based on the experience of Alfred Kim, MD, PhD, associate professor of medicine at Washington University School of Medicine in St Louis, Missouri.

Dr. Alfred Kim, director of the Washington University Lupus Clinic
Dr. Kim
Dr. Alfred Kim

 

 

“For a lot of people, losing control over their health is maybe the most frightening experience they can have, so I think a lot of patients use this as a way to kind of have ownership over their health,” Dr. Kim said. “Let’s say they’ve been to four doctors. No one can explain what’s going on. They’re getting frustrated, and so they just turn to solutions where they feel like they have ownership over the situation.”

Though the market is undoubtedly growing, the growth appears uneven across geography and institution types. Kim has seen a “fair number of referrals,” with patients coming in with results from a DTC test. Michael Putman, MD, MSci, assistant professor of medicine at the Medical College of Wisconsin in Milwaukee, hasn’t seen it much. “I know that patients can get testing done themselves independently, but I don’t have people routinely coming in with tests they’ve ordered in advance of our appointment,” Dr. Putman said, but, like Dr. Kim, he recognizes why patients might seek them out.

Dr. Michael Putman, an assistant professor of medicine at the Medical College of Wisconsin in Milwaukee, Wisconsin
Dr. Putman
Dr. Michael Putman


“I’m a big fan of patient empowerment, and I do think that medicine serves a gatekeeper role that sometimes can be a little too far,” Dr. Putman said. “I think there is value to patients being able to get more information and try to understand what is happening in their bodies. I have a lot of compassion for someone who would try to find testing outside of the normal channels.”

Indeed, bringing these test results to a visit could be informative in some scenarios. A negative ANA test, for example, pretty much excludes lupus 100%, Dr. Kim said. But a positive ANA doesn’t tell him much, and if his clinical suspicion for a condition is high, he likely would order that test anyway, even if the patient came in with their own results. Dr. Putman also pointed out that the vast majority of tests used in rheumatology have a high rate of false positives.

“I think that will be the major area where this causes quite a lot of grief to patients and some frustration to some providers,” he said. A rheumatoid factor test like the one Ms. Welsh ordered, for example, might test positive in 10 out of 100 people randomly gathered in a room, but the majority of those individuals would not have RA, he said.

That test is another popular rheumatology one, according to Timothy Niewold, MD, vice chair for research in the Hospital for Special Surgery Department of Medicine in New York City. Among the possible reasons people might order these tests are the delay in diagnosis that can often occur with a lot of rheumatologic conditions and that “it can take a while to see a rheumatologist, depending on what part of the country you’re in and what the availability is,” he said. He’s not surprised to see tests for Sjögren disease among the offerings, for example, because it’s a condition that’s difficult to diagnose but reasonably common within autoimmune diseases.

Dr. Timothy Niewold, vice chair for research in the Hospital for Special Surgery Department of Medicine in New York City
Ron Hester Photography
Dr. Timothy Niewold

 

 

 

Risks vs Benefits

DTC testing is not an answer to the national shortage of rheumatologists, however, especially given the risks that Dr. Niewold, Dr. Putman, and Dr. Kim worry outweigh potential benefits. On the one hand, getting online test results may help expedite a referral to a specialist, Dr. Niewold said. But a long wait for that appointment could then easily become a bigger source of anxiety than comfort, Dr. Putman said.

“It’s a trade-off where you are accepting a lot more people getting false-positive diagnoses and spending months thinking they have some disease where they might not, in exchange for a couple people who would have had a delayed diagnosis,” Dr. Putman said. “There’s an enormous amount of existential suffering,” that’s familiar to rheumatologists because some patients may dread the diagnosis of a rheumatic disease the way they might fear a cancer diagnosis, especially if they have lost a family member to a condition that they suspect they share, he said. “To put yourself into an existential catastrophe — that’s not a small harm.”

Dr. Niewold agreed, pointing out that patients with a positive ANA test may “get unnecessarily worried and stay up all night reading about lupus, getting scared for weeks on end before seeing a specialist.” And there are financial harms as well for patients who may order the same test multiple times, or a whole slate of tests, that they don’t need for hundreds or thousands of dollars. There’s also the lost time and effort of researching a condition or even seeking out support groups that patients may pursue, Dr. Niewold said.

The likely biggest risk to individuals, however, is the potential for overdiagnosis or misdiagnosis.

“If someone comes in and they’ve read the textbook on lupus and they have a positive ANA, it’s really hard as a rheumatologist to walk that back,” Dr. Putman said. “The human mind is a powerful thing,” he added, and people who get a positive test will likely start to notice things like joint pain or a rash on their cheeks and begin attributing it to a diagnosis they risk convincing themselves they have. “When people come into your clinic not knowing what a disease would look like and they just tell you how they’re feeling, it’s a much cleaner and more honest way to approach diagnosis.”

Most patients likely don’t realize, for example, that none of the tests rheumatologists usually order are diagnostic in and of themselves, Dr. Niewold said. “They’re all kind of like stars in the constellation of a diagnosis,” he said. “They’re helpful, but none of them is sufficient by itself.”

Dr. Killeen agreed, noting that “consumers might not understand the nuances of these tests well enough to know whether it is appropriate to order them or how to interpret the results correctly.” Given the long-term implications of a diagnosis for a rheumatologic disease, “I would have concerns about consumers ordering and interpreting rheumatologic tests without working closely with their physicians,” Dr. Killeen said. “The main concern that lab experts have about direct-to-consumer tests is the potential for people to get misleading results and/or to misinterpret their results, which in turn could lead to people not getting the treatment they need or getting treatment when they don’t need any at all.”

It’s one thing for patients to come in asking for a particular treatment they may not need but which a doctor may be able to dissuade them from seeking. But Dr. Kim also pointed out the risk that patients may decide to treat themselves with therapies that haven’t undergone rigorous testing or haven’t been recommended by a physician.

“We tend to have people who come in with a pretty clear idea of what they want done, but the problem is, we don’t know if their reasoning is correct from a clinical perspective,” Dr. Kim said. Companies offer these tests with the belief that they’re “providing patients a choice, an option to take ownership,” he said, “but the potential harm can be realized very quickly because there are going to be people who are misdiagnosing themselves and, worse yet, may then pursue their own treatment plan that’s going in the opposite direction of where we think it needs to go.”

Or, on the flip side, if a patient erroneously believes they have the answer to what ails them, it may delay diagnosis of a more serious condition that’s rarer or harder to detect. Kim pointed to, for example, intravascular lymphoma, which is notoriously as difficult to identify as it is rare and aggressive. If a patient’s confirmation bias has led them to believe they have an autoimmune condition, they may not receive the more serious diagnosis until it’s advanced too far to treat.
 

 

 

Patient-Provider Relationship Friction

Another concern is how these tests may lead to confusion and frustration that can erode the patient-provider relationship, particularly because most patients don’t know how to interpret the results or understand the bigger context in which the results have to be interpreted. Many patients may think a test can come back with a binary answer, a positive or negative, and that means they do or don’t have a condition. That’s generally true for pregnancy tests, COVID tests, and sexually transmitted infection tests — the kinds of tests that have long been available to consumers and which have fairly straightforward answers.

But physicians know that’s not the case for many conditions, particularly those in rheumatology.

“In rheumatic diseases, because the tests have such marginal value in terms of diagnosis, almost always we develop a suspicion before we even think about ordering the tests, and then that dictates whether or not we cross that threshold,” Dr. Kim said. “A negative test doesn’t exclude the fact that you may have disease X, but a positive test also doesn’t mean you have disease X. All they provide is an idea of the risk.”

But some patients who come in with DTC test results have “already made the decision in their mind that they have a certain condition,” Dr. Kim said. “This is obviously dangerous because the majority of these patients do not have the condition they think they have, and it leaves a very uncomfortable feeling after the visit because they feel like they’ve been either betrayed by me or by the test, and they leave more confused.”

Patients may also come in with tests that a doctor isn’t familiar with or isn’t sure how to interpret on its own, at least for that particular patient.

“For ANA testing, we have a pretty good idea of its positive and negative predictive value because it’s ordered so much, but for many of these tests being offered, there are specific autoantibodies, and we tend to only get them in people where there’s a clinical suspicion,” Dr. Kim said. “Within that very specific context, we kind of understand what that value means, but if you give it to the general public, then those numbers aren’t as applicable and most likely overestimate the risk of disease.”

Even if providers consider the results of a DTC test in their differential, they may want to be sure it’s from a trustworthy source. “If a provider is uncertain about whether a direct-to-consumer testing company is reputable or about whether a direct-to-consumer test result is reliable, I would encourage them to consult with their laboratory medicine colleagues,” Dr. Killeen said.
 

Responding to Patients

Like any other patient coming to a clinical visit, the most common reason patients are likely ordering these tests is that they’re seeking answers. Kim doesn’t typically see patients doing their own monitoring for diagnosed conditions between visits — the expense would add up too quickly — or testing for genetic markers, which likely wouldn’t be very helpful either.

 

 

“Even though most of our diseases probably have a genetic underpinning, how much it contributes is always unclear,” Dr. Kim said. Even conditions with clear genetic variants, such as familial Mediterranean fever, spondyloarthritis, and Behçet disease, can only support a diagnosis, not diagnose it on its own, Dr. Killeen said. And these are not among the tests currently available on most DTC company sites.

While there are also tests that can offer information about genetic risks for certain medications, such as a thiopurine methyltransferase test to find out if a patient lacks the enzyme needed to break down the immunosuppressant drug azathioprine, Kim hasn’t seen patients seeking these out either.

“The more global and more compassionate way to think about this is that we have a lot of people who are struggling to understand what’s going on with their bodies, and most physicians really don’t know what the next steps are for these people,” Dr. Kim said. “They’re desperate, and their quality of life is so poor that they’re going to take extreme steps to try to manage their own frustration with this condition.”

That means clinicians’ most powerful tools when patients come in with DTC test results are their listening skills.

“Empathy is the most important thing, just being able to share the patient’s frustration to the point where they had to take matters into their own hands,” Dr. Kim said. “I think a lot of rheumatologists are actually pretty comfortable being in this position.”

Additionally, doctors should know that some patients may be engaging in attempts to self-diagnose, self-treat, or otherwise self-manage their symptoms or perceived condition. “They just need to be aware and try to make sure there’s no harm being done,” Dr. Kim said.

Ms. Welsh didn’t seek treatment or diagnosis on her own, but getting her test also did not give her the control she was seeking. “Looking back, it was kind of a waste of money, but it felt good in the moment,” Ms. Welsh said. “I was so upset, and I wanted that control, and in the end, it didn’t get me results any sooner, and it didn’t give me peace of mind.”

It was Ms. Welsh’s primary care doctor listening to her concerns, ordering the same test she had ordered with several others, and working with her to seek answers that reassured her that her provider cared about her well-being.

“A lot of what I do in my business is reassure people that you know what they have is treatable or not going to end their life as they know it,” Dr. Putman said. “And you certainly can’t reassure them if they’re not in your clinic yet.”

Dr. Putman has participated in clinical trials with AbbVie, consulting with Novartis and GSK, and clinical trials and consulting with Amgen and AstraZeneca. Dr. Niewold reported receiving research grants from EMD Serono and Zenas BioPharma and consulting for Thermo Fisher Scientific, Progentec Diagnostics, Roivant Sciences, AstraZeneca, S3 Connected Health, Flagship Pioneering, and Guidepoint. Dr. Kim reported sponsored research agreements with AstraZeneca, Bristol-Myers Squibb, Novartis, and CRISPR Therapeutics; royalties from Kypha; and consulting/speaking for Amgen, ANI Pharmaceuticals, Atara Biotherapeutics, Aurinia Pharmaceuticals, CARGO Therapeutics, Exagen Diagnostics, GSK, Hinge Bio, Kypha, Progentec Diagnostics, Synthekine, and UpToDate. Dr. Killeen had no relevant financial relationships to disclose.
 

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

 

When Jennifer Welsh, a 40-year-old from New Britain, Connecticut, visited her doctor about pain in her joints and neck, her doctor sent her to the emergency department (ED) to rule out meningitis. The ED did rule that out, as well as strep, so Ms. Welsh went to her follow-up appointment a few days later, hoping for answers or at least more tests to get those answers.

Instead, the doctor — a different one from the same practice as her primary care physician (PCP) — wouldn’t even talk to Ms. Welsh about her symptoms because she couldn’t see the ED’s results and refused to view the results that Ms. Welsh could pull up online.

“She just completely shut me down,” Ms. Welsh recalled. “It was a really awful appointment, and I left in tears. I was in physical pain, I had just been to the ER, nothing is really resolved, I’m stressed out about it, and this woman is completely dismissing me.”

She had been able to schedule an appointment with her regular PCP later that week, but after the harrowing experience with this doctor, she wondered if her PCP would order the rheumatoid arthritis (RA) test that Ms. Welsh suspected she needed. So, she took matters into her own hands.

“I was searching for what test to ask for from my doctor,” she said, and she found that she could order it on her own from a major lab company she was already familiar with. For around $100, “I could get it done and see what it says on my own,” she said.

But that’s not how it worked out. Her regular PCP apologized for the other doctor’s behavior and ordered the RA test as well as additional tests — and got results while Ms. Welsh still waited for the one she ordered to arrive over a week later.

At first, Ms. Welsh was grateful she could order the RA test without her doctor’s referral. “I felt it gave me a sense of control over the situation that I felt really not in control of, until the system failed me, and I didn’t get the results,” she said. But then, “not having someone I could call and get an answer about why my tests were delayed, why I wasn’t able to access them, why it was taking so long — it was definitely anxiety-inducing.”
 

A Growing Market

Ms. Welsh is one of a growing number of patients who are ordering direct-to-consumer (DTC) lab tests without the recommendation or guidance of a doctor. They’re offered online by labs ranging from well-established giants like Quest and Labcorp to smaller, potentially less vetted companies, although some smaller companies contract with larger companies like Quest. Combined, the DTC market is projected to be worth $2 billion by 2025.

Yet the burgeoning industry has also drawn critiques from both bioethicists and privacy experts. A research letter in JAMA in 2023, for example, found that less than half of the 21 companies identified in an online search declared Health Insurance Portability and Accountability Act compliance, while more than half “indicated the potential use of consumer data for research purposes either internally or through third-party sharing.” That study found the most commonly offered tests were related to diabetes, the thyroid, and vitamin levels, and hormone tests for men and women, such as testosterone or estradiol.

But a number of companies also offer tests related to rheumatologic conditions. A handful of tests offered by Labcorp, for example, could be used in rheumatology, such as tests for celiac antibodies or high-sensitivity C-reactive protein. Quest similarly offers a handful of autoimmune-related tests. But other companies offer a long slate of autoimmune or antibody tests.

The antinuclear antibody (ANA) test and RA panel offered by Quest are the same tests, run and analyzed in the same labs, as those ordered by physicians and hospitals, according to James Faix, MD, the medical director of immunology at Quest Diagnostics. Their RA panel includes rheumatoid factor and anti-cyclic citrullinated peptide as well as antibody to mutated citrullinated vimentin, “which may detect approximately 10%-15%” of patients who test negative to the first two.

Quest’s ANA test with reflex costs $112, and its RA panel costs $110, price points that are similar across other companies’ offerings. Labcorp declined to respond to questions about its DTC tests, and several smaller companies did not respond to queries about their offerings. It can therefore be hard to assess what’s included or what the quality is of many DTC tests, particularly from smaller, less established companies.
 

 

 

Oversight and Quality Control

Anthony Killeen, MD, PhD, president of the Association for Diagnostics & Laboratory Medicine (ADLM) and director of Clinical Laboratories at the University of Minnesota Medical Center in Minneapolis, said via email that the ADLM supports “expanding consumer access to direct-to-consumer laboratory testing services that have demonstrated analytical and clinical validity and clinical utility,” given the importance of individuals learning about their health status and becoming more involved in health decisions. But the ADLM also recommends “that only CLIA-certified laboratories perform direct-to-consumer testing,” he said.

Dr. Anthony Killeen, president of the Association for Diagnostics & Laboratory Medicine (ADLM) and director of Clinical Laboratories at the University of Minnesota Medical Center in Minneapolis
Association for Diagnostics & Laboratory Medicine
Dr. Anthony Killeen

“There are direct-to-consumer tests on the market that are not medical-grade laboratory tests and that may be performed in nonaccredited laboratories,” Dr. Killeen said. “We advise consumers to steer clear of such tests.” The ADLM also encourages consumers to “work with qualified healthcare providers when making decisions based off the results they receive from any direct-to-consumer tests” and recommends that DTC test companies “provide consumers with sufficient information and/or access to expert help to assist them in ordering tests and interpreting the results.”

Yet it’s unclear how much support, if any, consumers can receive in terms of understanding what their tests mean. Most of the companies in the 2023 study offered optional follow-up with a healthcare professional, but these professionals ranged from physicians to “health coaches,” and all the companies had disclaimers that “test results did not constitute medical advice.”

At Quest, the only company to respond to this news organization’s request for comment, consumer-initiated tests ordered online are first reviewed by a physician at PWNHealth, an independent, third-party physician network, to determine that it’s appropriate before the lab order is actually placed.

“Once results are available, individuals have the option to discuss their results with an independent physician at no extra cost,” Dr. Faix said. ANA or RA results outside the normal ranges may trigger a “call from a PWNHealth healthcare coordinator, who can help provide information, suggestions on next steps, and set up time for the individual to speak with an independent physician to discuss questions or concerns regarding the results,” he said.

“Our goal is not to replace the role of a healthcare provider,” Dr. Faix said. “We are providing an alternate way for people to engage with the healthcare system that offers convenience, gives people more control over their own healthcare journeys, and meets them where they are, supporting both consumers and their care teams.” The company has expanded its offerings from an initial 30 tests made available in 2018 to over 130 today, deciding which to offer “based on consumer research and expertise of clinical experts.” The company has also “seen steady interest in our two consumer rheumatology offerings,” Dr. Faix said.
 

The DTC Landscape in Rheumatology

Within rheumatology, among the most popular tests is for ANA, based on the experience of Alfred Kim, MD, PhD, associate professor of medicine at Washington University School of Medicine in St Louis, Missouri.

Dr. Alfred Kim, director of the Washington University Lupus Clinic
Dr. Kim
Dr. Alfred Kim

 

 

“For a lot of people, losing control over their health is maybe the most frightening experience they can have, so I think a lot of patients use this as a way to kind of have ownership over their health,” Dr. Kim said. “Let’s say they’ve been to four doctors. No one can explain what’s going on. They’re getting frustrated, and so they just turn to solutions where they feel like they have ownership over the situation.”

Though the market is undoubtedly growing, the growth appears uneven across geography and institution types. Kim has seen a “fair number of referrals,” with patients coming in with results from a DTC test. Michael Putman, MD, MSci, assistant professor of medicine at the Medical College of Wisconsin in Milwaukee, hasn’t seen it much. “I know that patients can get testing done themselves independently, but I don’t have people routinely coming in with tests they’ve ordered in advance of our appointment,” Dr. Putman said, but, like Dr. Kim, he recognizes why patients might seek them out.

Dr. Michael Putman, an assistant professor of medicine at the Medical College of Wisconsin in Milwaukee, Wisconsin
Dr. Putman
Dr. Michael Putman


“I’m a big fan of patient empowerment, and I do think that medicine serves a gatekeeper role that sometimes can be a little too far,” Dr. Putman said. “I think there is value to patients being able to get more information and try to understand what is happening in their bodies. I have a lot of compassion for someone who would try to find testing outside of the normal channels.”

Indeed, bringing these test results to a visit could be informative in some scenarios. A negative ANA test, for example, pretty much excludes lupus 100%, Dr. Kim said. But a positive ANA doesn’t tell him much, and if his clinical suspicion for a condition is high, he likely would order that test anyway, even if the patient came in with their own results. Dr. Putman also pointed out that the vast majority of tests used in rheumatology have a high rate of false positives.

“I think that will be the major area where this causes quite a lot of grief to patients and some frustration to some providers,” he said. A rheumatoid factor test like the one Ms. Welsh ordered, for example, might test positive in 10 out of 100 people randomly gathered in a room, but the majority of those individuals would not have RA, he said.

That test is another popular rheumatology one, according to Timothy Niewold, MD, vice chair for research in the Hospital for Special Surgery Department of Medicine in New York City. Among the possible reasons people might order these tests are the delay in diagnosis that can often occur with a lot of rheumatologic conditions and that “it can take a while to see a rheumatologist, depending on what part of the country you’re in and what the availability is,” he said. He’s not surprised to see tests for Sjögren disease among the offerings, for example, because it’s a condition that’s difficult to diagnose but reasonably common within autoimmune diseases.

Dr. Timothy Niewold, vice chair for research in the Hospital for Special Surgery Department of Medicine in New York City
Ron Hester Photography
Dr. Timothy Niewold

 

 

 

Risks vs Benefits

DTC testing is not an answer to the national shortage of rheumatologists, however, especially given the risks that Dr. Niewold, Dr. Putman, and Dr. Kim worry outweigh potential benefits. On the one hand, getting online test results may help expedite a referral to a specialist, Dr. Niewold said. But a long wait for that appointment could then easily become a bigger source of anxiety than comfort, Dr. Putman said.

“It’s a trade-off where you are accepting a lot more people getting false-positive diagnoses and spending months thinking they have some disease where they might not, in exchange for a couple people who would have had a delayed diagnosis,” Dr. Putman said. “There’s an enormous amount of existential suffering,” that’s familiar to rheumatologists because some patients may dread the diagnosis of a rheumatic disease the way they might fear a cancer diagnosis, especially if they have lost a family member to a condition that they suspect they share, he said. “To put yourself into an existential catastrophe — that’s not a small harm.”

Dr. Niewold agreed, pointing out that patients with a positive ANA test may “get unnecessarily worried and stay up all night reading about lupus, getting scared for weeks on end before seeing a specialist.” And there are financial harms as well for patients who may order the same test multiple times, or a whole slate of tests, that they don’t need for hundreds or thousands of dollars. There’s also the lost time and effort of researching a condition or even seeking out support groups that patients may pursue, Dr. Niewold said.

The likely biggest risk to individuals, however, is the potential for overdiagnosis or misdiagnosis.

“If someone comes in and they’ve read the textbook on lupus and they have a positive ANA, it’s really hard as a rheumatologist to walk that back,” Dr. Putman said. “The human mind is a powerful thing,” he added, and people who get a positive test will likely start to notice things like joint pain or a rash on their cheeks and begin attributing it to a diagnosis they risk convincing themselves they have. “When people come into your clinic not knowing what a disease would look like and they just tell you how they’re feeling, it’s a much cleaner and more honest way to approach diagnosis.”

Most patients likely don’t realize, for example, that none of the tests rheumatologists usually order are diagnostic in and of themselves, Dr. Niewold said. “They’re all kind of like stars in the constellation of a diagnosis,” he said. “They’re helpful, but none of them is sufficient by itself.”

Dr. Killeen agreed, noting that “consumers might not understand the nuances of these tests well enough to know whether it is appropriate to order them or how to interpret the results correctly.” Given the long-term implications of a diagnosis for a rheumatologic disease, “I would have concerns about consumers ordering and interpreting rheumatologic tests without working closely with their physicians,” Dr. Killeen said. “The main concern that lab experts have about direct-to-consumer tests is the potential for people to get misleading results and/or to misinterpret their results, which in turn could lead to people not getting the treatment they need or getting treatment when they don’t need any at all.”

It’s one thing for patients to come in asking for a particular treatment they may not need but which a doctor may be able to dissuade them from seeking. But Dr. Kim also pointed out the risk that patients may decide to treat themselves with therapies that haven’t undergone rigorous testing or haven’t been recommended by a physician.

“We tend to have people who come in with a pretty clear idea of what they want done, but the problem is, we don’t know if their reasoning is correct from a clinical perspective,” Dr. Kim said. Companies offer these tests with the belief that they’re “providing patients a choice, an option to take ownership,” he said, “but the potential harm can be realized very quickly because there are going to be people who are misdiagnosing themselves and, worse yet, may then pursue their own treatment plan that’s going in the opposite direction of where we think it needs to go.”

Or, on the flip side, if a patient erroneously believes they have the answer to what ails them, it may delay diagnosis of a more serious condition that’s rarer or harder to detect. Kim pointed to, for example, intravascular lymphoma, which is notoriously as difficult to identify as it is rare and aggressive. If a patient’s confirmation bias has led them to believe they have an autoimmune condition, they may not receive the more serious diagnosis until it’s advanced too far to treat.
 

 

 

Patient-Provider Relationship Friction

Another concern is how these tests may lead to confusion and frustration that can erode the patient-provider relationship, particularly because most patients don’t know how to interpret the results or understand the bigger context in which the results have to be interpreted. Many patients may think a test can come back with a binary answer, a positive or negative, and that means they do or don’t have a condition. That’s generally true for pregnancy tests, COVID tests, and sexually transmitted infection tests — the kinds of tests that have long been available to consumers and which have fairly straightforward answers.

But physicians know that’s not the case for many conditions, particularly those in rheumatology.

“In rheumatic diseases, because the tests have such marginal value in terms of diagnosis, almost always we develop a suspicion before we even think about ordering the tests, and then that dictates whether or not we cross that threshold,” Dr. Kim said. “A negative test doesn’t exclude the fact that you may have disease X, but a positive test also doesn’t mean you have disease X. All they provide is an idea of the risk.”

But some patients who come in with DTC test results have “already made the decision in their mind that they have a certain condition,” Dr. Kim said. “This is obviously dangerous because the majority of these patients do not have the condition they think they have, and it leaves a very uncomfortable feeling after the visit because they feel like they’ve been either betrayed by me or by the test, and they leave more confused.”

Patients may also come in with tests that a doctor isn’t familiar with or isn’t sure how to interpret on its own, at least for that particular patient.

“For ANA testing, we have a pretty good idea of its positive and negative predictive value because it’s ordered so much, but for many of these tests being offered, there are specific autoantibodies, and we tend to only get them in people where there’s a clinical suspicion,” Dr. Kim said. “Within that very specific context, we kind of understand what that value means, but if you give it to the general public, then those numbers aren’t as applicable and most likely overestimate the risk of disease.”

Even if providers consider the results of a DTC test in their differential, they may want to be sure it’s from a trustworthy source. “If a provider is uncertain about whether a direct-to-consumer testing company is reputable or about whether a direct-to-consumer test result is reliable, I would encourage them to consult with their laboratory medicine colleagues,” Dr. Killeen said.
 

Responding to Patients

Like any other patient coming to a clinical visit, the most common reason patients are likely ordering these tests is that they’re seeking answers. Kim doesn’t typically see patients doing their own monitoring for diagnosed conditions between visits — the expense would add up too quickly — or testing for genetic markers, which likely wouldn’t be very helpful either.

 

 

“Even though most of our diseases probably have a genetic underpinning, how much it contributes is always unclear,” Dr. Kim said. Even conditions with clear genetic variants, such as familial Mediterranean fever, spondyloarthritis, and Behçet disease, can only support a diagnosis, not diagnose it on its own, Dr. Killeen said. And these are not among the tests currently available on most DTC company sites.

While there are also tests that can offer information about genetic risks for certain medications, such as a thiopurine methyltransferase test to find out if a patient lacks the enzyme needed to break down the immunosuppressant drug azathioprine, Kim hasn’t seen patients seeking these out either.

“The more global and more compassionate way to think about this is that we have a lot of people who are struggling to understand what’s going on with their bodies, and most physicians really don’t know what the next steps are for these people,” Dr. Kim said. “They’re desperate, and their quality of life is so poor that they’re going to take extreme steps to try to manage their own frustration with this condition.”

That means clinicians’ most powerful tools when patients come in with DTC test results are their listening skills.

“Empathy is the most important thing, just being able to share the patient’s frustration to the point where they had to take matters into their own hands,” Dr. Kim said. “I think a lot of rheumatologists are actually pretty comfortable being in this position.”

Additionally, doctors should know that some patients may be engaging in attempts to self-diagnose, self-treat, or otherwise self-manage their symptoms or perceived condition. “They just need to be aware and try to make sure there’s no harm being done,” Dr. Kim said.

Ms. Welsh didn’t seek treatment or diagnosis on her own, but getting her test also did not give her the control she was seeking. “Looking back, it was kind of a waste of money, but it felt good in the moment,” Ms. Welsh said. “I was so upset, and I wanted that control, and in the end, it didn’t get me results any sooner, and it didn’t give me peace of mind.”

It was Ms. Welsh’s primary care doctor listening to her concerns, ordering the same test she had ordered with several others, and working with her to seek answers that reassured her that her provider cared about her well-being.

“A lot of what I do in my business is reassure people that you know what they have is treatable or not going to end their life as they know it,” Dr. Putman said. “And you certainly can’t reassure them if they’re not in your clinic yet.”

Dr. Putman has participated in clinical trials with AbbVie, consulting with Novartis and GSK, and clinical trials and consulting with Amgen and AstraZeneca. Dr. Niewold reported receiving research grants from EMD Serono and Zenas BioPharma and consulting for Thermo Fisher Scientific, Progentec Diagnostics, Roivant Sciences, AstraZeneca, S3 Connected Health, Flagship Pioneering, and Guidepoint. Dr. Kim reported sponsored research agreements with AstraZeneca, Bristol-Myers Squibb, Novartis, and CRISPR Therapeutics; royalties from Kypha; and consulting/speaking for Amgen, ANI Pharmaceuticals, Atara Biotherapeutics, Aurinia Pharmaceuticals, CARGO Therapeutics, Exagen Diagnostics, GSK, Hinge Bio, Kypha, Progentec Diagnostics, Synthekine, and UpToDate. Dr. Killeen had no relevant financial relationships to disclose.
 

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

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Air Travel Alters Insulin Pump Delivery on Takeoff, Landing

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Fri, 09/27/2024 - 13:37

Airplane travel consistently causes insulin pumps to over-deliver a little over half a unit on takeoff and under-deliver a bit less on landing, new research found.

This phenomenon is due to air bubble formation and reabsorption in the insulin caused by ambient pressure changes in the airplane’s cabin. It has nothing to do with the pump itself and happens with all insulin pumps, including those in hybrid closed-loop systems, Bruce King, MD, said at the European Association for the Study of Diabetes (EASD) 2024 Annual Meeting.

The extent to which this affects people with diabetes who use insulin pumps depends on their dose and insulin sensitivity among other factors, but all who fly should be aware of the possibility and take precautions, particularly with children, Dr. King, a pediatric endocrinologist at John Hunter Children’s Hospital, Newcastle, Australia, told this news organization.

“Basically, the pumps are very safe in flight, but they deliver a little bit of extra insulin when you go up and stop delivery when you come back down again. There are a couple of simple steps that people can take to make sure that they don’t have problems during the flight,” he said.

Specifically, he advised that for pumps with tubing, wearers can disconnect just prior to takeoff and reconnect when the plane reaches cruising altitude, about 20 minutes into the flight. The insulin will still come out, but it won’t be delivered to the person, Dr. King said.

On descent, they can disconnect after landing and prime the line to remove the insulin deficit.

With the Omnipod, which can’t be disconnected, the only solution is to eat a small snack on takeoff. And on landing, eat another small snack such as a banana, and give a bolus for it to overcome the blockage of insulin delivery.

In any case, Dr. King said, “One of the most important things is informing people with diabetes about this effect so they’re aware of it and can act appropriately when they fly.”

Asked to comment, Nicholas B. Argento, MD, a practicing endocrinologist in Columbia, Maryland, and author of the American Diabetes Association’s book, “Putting Your Patients on the Pump,” called the issue a “minor effect,” adding, “While I think it would be reasonable to make those changes ... it seems like a lot of effort for a difference of 0.6 units extra on ascent and 0.5 units less on descent.”

He noted there is a risk that the individual might forget to reattach the pump after 20 minutes, leading to hyperglycemia and even diabetic ketoacidosis. Instead, “one could put the pump on suspend for 1 hour on ascent. That would not stop the extra insulin but would net less insulin during that time period.”

And after descent, “you have to walk a lot in most cases, so I don’t think they need to take this into consideration. So many other factors change in air travel that I don’t think this is a significant enough effect to make the effort.”
 

A Known Phenomenon, the Manufacturers Are Aware

This phenomenon has been described previously, including by Dr. King in a 2011 Diabetes Care paper. The new research is among a series of experiments funded by the European Union Aviation Safety Agency in collaboration with the pump manufacturers Medtronic (MiniMed), Tandem (t:slim), and Insulet (Omnipod), primarily aimed at establishing safety parameters for airline pilots with insulin-treated diabetes.

Both the Omnipod DASH and Omnipod 5 User Guides include warnings about unintended insulin delivery during flight, and both advise users to check their blood glucose levels frequently while flying.

In a statement, Jordan Pinsker, MD, Chief Medical Officer at Tandem Diabetes Care, told this news organization, “While it has long been known that routine air travel pressure changes can cause minor fluctuations in insulin pump delivery, the impact of these variations have been found to be generally minor as it relates to glycemic control.”

Dr. Pinsker added that the Tandem Mobi user manual includes a warning related to significant pressure changes in specific air travel situations and offers guidance to disconnect. However, “the t:slim X2 pump’s microdelivery technology limits how much extra insulin can get delivered from air pressure changes due to a mechanism between the tubing and the contents of the bag inside the cartridge.”

Medtronic’s user guide says that the 780G system has not been tested at altitudes higher than 10,150 feet.
 

Hypobaric Chamber Used to Simulate Flight

The study was conducted in vitro, in a hypobaric chamber designed to mimic atmospheric changes during commercial flight. A total of 10 Medtronic MiniMed 780G, 10 Tandem t:slim X2, and six Insulet Omnipod DASH pumps were tested.

The hypobaric chamber was depressurized to 550 mm Hg over a 20-minute ascent, maintained at a 30-minute cruise, followed by a 20-minute descent to ground (750 mm Hg). During the simulated flights, insulin infusion was set at 0.6 units per hour, a rate typical for both adults and children, to allow accurate measurements with multiple flights.

Insulin delivery rates and bubble formation were recorded by attaching infusion sets to open-ended 100 µL capillary tubes against 1-mm grid paper.

Full cartridges — Medtronic: 3 mL, t:slim: 3 mL, and Omnipod: 2 mL — all over-delivered 0.60 units of insulin over a 20-minute ascent compared with delivery at ground level. And during descent, the cartridges under-delivered 0.51 units of insulin.
 

But if There’s Rapid Decompression…

In a separate protocol, insulin infusion sets without pumps were tested in a simulation of rapid decompression. Insulin delivery during both ascent and descent showed statistically significant differences compared with delivery at ground level (both P < .001). In this scenario, fluid delivery was equivalent to 5.6 units of excess insulin.

Dr. King pointed out that while these are rare events, about 40-50 occur annually. One was the widely publicized Alaska Airlines flight in January 2024 when the door fell off in midair.

Dr. Argento said, “The catastrophic decompression is of note, and I would want patients to be aware of this, but it is asking a lot for someone thinking they are going to die to remember to disconnect as it starts.”

The researchers are investigating this phenomenon further in people, including airline pilots.

Dr. King’s research group has been involved in research with Medtronic, Tandem, and Insulet. Dr. Argento has consulted or been on advisory boards for Eli Lilly Diabetes, Dexcom, Diabeloop, Convatec, and Senseonics and served on the speakers’ bureaus for Boehringer Ingelheim, Dexcom, Eli Lilly Diabetes, MannKind, Novo Nordisk, Xeris, and Zealand Pharma.
 

A version of this article appeared on Medscape.com.

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Airplane travel consistently causes insulin pumps to over-deliver a little over half a unit on takeoff and under-deliver a bit less on landing, new research found.

This phenomenon is due to air bubble formation and reabsorption in the insulin caused by ambient pressure changes in the airplane’s cabin. It has nothing to do with the pump itself and happens with all insulin pumps, including those in hybrid closed-loop systems, Bruce King, MD, said at the European Association for the Study of Diabetes (EASD) 2024 Annual Meeting.

The extent to which this affects people with diabetes who use insulin pumps depends on their dose and insulin sensitivity among other factors, but all who fly should be aware of the possibility and take precautions, particularly with children, Dr. King, a pediatric endocrinologist at John Hunter Children’s Hospital, Newcastle, Australia, told this news organization.

“Basically, the pumps are very safe in flight, but they deliver a little bit of extra insulin when you go up and stop delivery when you come back down again. There are a couple of simple steps that people can take to make sure that they don’t have problems during the flight,” he said.

Specifically, he advised that for pumps with tubing, wearers can disconnect just prior to takeoff and reconnect when the plane reaches cruising altitude, about 20 minutes into the flight. The insulin will still come out, but it won’t be delivered to the person, Dr. King said.

On descent, they can disconnect after landing and prime the line to remove the insulin deficit.

With the Omnipod, which can’t be disconnected, the only solution is to eat a small snack on takeoff. And on landing, eat another small snack such as a banana, and give a bolus for it to overcome the blockage of insulin delivery.

In any case, Dr. King said, “One of the most important things is informing people with diabetes about this effect so they’re aware of it and can act appropriately when they fly.”

Asked to comment, Nicholas B. Argento, MD, a practicing endocrinologist in Columbia, Maryland, and author of the American Diabetes Association’s book, “Putting Your Patients on the Pump,” called the issue a “minor effect,” adding, “While I think it would be reasonable to make those changes ... it seems like a lot of effort for a difference of 0.6 units extra on ascent and 0.5 units less on descent.”

He noted there is a risk that the individual might forget to reattach the pump after 20 minutes, leading to hyperglycemia and even diabetic ketoacidosis. Instead, “one could put the pump on suspend for 1 hour on ascent. That would not stop the extra insulin but would net less insulin during that time period.”

And after descent, “you have to walk a lot in most cases, so I don’t think they need to take this into consideration. So many other factors change in air travel that I don’t think this is a significant enough effect to make the effort.”
 

A Known Phenomenon, the Manufacturers Are Aware

This phenomenon has been described previously, including by Dr. King in a 2011 Diabetes Care paper. The new research is among a series of experiments funded by the European Union Aviation Safety Agency in collaboration with the pump manufacturers Medtronic (MiniMed), Tandem (t:slim), and Insulet (Omnipod), primarily aimed at establishing safety parameters for airline pilots with insulin-treated diabetes.

Both the Omnipod DASH and Omnipod 5 User Guides include warnings about unintended insulin delivery during flight, and both advise users to check their blood glucose levels frequently while flying.

In a statement, Jordan Pinsker, MD, Chief Medical Officer at Tandem Diabetes Care, told this news organization, “While it has long been known that routine air travel pressure changes can cause minor fluctuations in insulin pump delivery, the impact of these variations have been found to be generally minor as it relates to glycemic control.”

Dr. Pinsker added that the Tandem Mobi user manual includes a warning related to significant pressure changes in specific air travel situations and offers guidance to disconnect. However, “the t:slim X2 pump’s microdelivery technology limits how much extra insulin can get delivered from air pressure changes due to a mechanism between the tubing and the contents of the bag inside the cartridge.”

Medtronic’s user guide says that the 780G system has not been tested at altitudes higher than 10,150 feet.
 

Hypobaric Chamber Used to Simulate Flight

The study was conducted in vitro, in a hypobaric chamber designed to mimic atmospheric changes during commercial flight. A total of 10 Medtronic MiniMed 780G, 10 Tandem t:slim X2, and six Insulet Omnipod DASH pumps were tested.

The hypobaric chamber was depressurized to 550 mm Hg over a 20-minute ascent, maintained at a 30-minute cruise, followed by a 20-minute descent to ground (750 mm Hg). During the simulated flights, insulin infusion was set at 0.6 units per hour, a rate typical for both adults and children, to allow accurate measurements with multiple flights.

Insulin delivery rates and bubble formation were recorded by attaching infusion sets to open-ended 100 µL capillary tubes against 1-mm grid paper.

Full cartridges — Medtronic: 3 mL, t:slim: 3 mL, and Omnipod: 2 mL — all over-delivered 0.60 units of insulin over a 20-minute ascent compared with delivery at ground level. And during descent, the cartridges under-delivered 0.51 units of insulin.
 

But if There’s Rapid Decompression…

In a separate protocol, insulin infusion sets without pumps were tested in a simulation of rapid decompression. Insulin delivery during both ascent and descent showed statistically significant differences compared with delivery at ground level (both P < .001). In this scenario, fluid delivery was equivalent to 5.6 units of excess insulin.

Dr. King pointed out that while these are rare events, about 40-50 occur annually. One was the widely publicized Alaska Airlines flight in January 2024 when the door fell off in midair.

Dr. Argento said, “The catastrophic decompression is of note, and I would want patients to be aware of this, but it is asking a lot for someone thinking they are going to die to remember to disconnect as it starts.”

The researchers are investigating this phenomenon further in people, including airline pilots.

Dr. King’s research group has been involved in research with Medtronic, Tandem, and Insulet. Dr. Argento has consulted or been on advisory boards for Eli Lilly Diabetes, Dexcom, Diabeloop, Convatec, and Senseonics and served on the speakers’ bureaus for Boehringer Ingelheim, Dexcom, Eli Lilly Diabetes, MannKind, Novo Nordisk, Xeris, and Zealand Pharma.
 

A version of this article appeared on Medscape.com.

Airplane travel consistently causes insulin pumps to over-deliver a little over half a unit on takeoff and under-deliver a bit less on landing, new research found.

This phenomenon is due to air bubble formation and reabsorption in the insulin caused by ambient pressure changes in the airplane’s cabin. It has nothing to do with the pump itself and happens with all insulin pumps, including those in hybrid closed-loop systems, Bruce King, MD, said at the European Association for the Study of Diabetes (EASD) 2024 Annual Meeting.

The extent to which this affects people with diabetes who use insulin pumps depends on their dose and insulin sensitivity among other factors, but all who fly should be aware of the possibility and take precautions, particularly with children, Dr. King, a pediatric endocrinologist at John Hunter Children’s Hospital, Newcastle, Australia, told this news organization.

“Basically, the pumps are very safe in flight, but they deliver a little bit of extra insulin when you go up and stop delivery when you come back down again. There are a couple of simple steps that people can take to make sure that they don’t have problems during the flight,” he said.

Specifically, he advised that for pumps with tubing, wearers can disconnect just prior to takeoff and reconnect when the plane reaches cruising altitude, about 20 minutes into the flight. The insulin will still come out, but it won’t be delivered to the person, Dr. King said.

On descent, they can disconnect after landing and prime the line to remove the insulin deficit.

With the Omnipod, which can’t be disconnected, the only solution is to eat a small snack on takeoff. And on landing, eat another small snack such as a banana, and give a bolus for it to overcome the blockage of insulin delivery.

In any case, Dr. King said, “One of the most important things is informing people with diabetes about this effect so they’re aware of it and can act appropriately when they fly.”

Asked to comment, Nicholas B. Argento, MD, a practicing endocrinologist in Columbia, Maryland, and author of the American Diabetes Association’s book, “Putting Your Patients on the Pump,” called the issue a “minor effect,” adding, “While I think it would be reasonable to make those changes ... it seems like a lot of effort for a difference of 0.6 units extra on ascent and 0.5 units less on descent.”

He noted there is a risk that the individual might forget to reattach the pump after 20 minutes, leading to hyperglycemia and even diabetic ketoacidosis. Instead, “one could put the pump on suspend for 1 hour on ascent. That would not stop the extra insulin but would net less insulin during that time period.”

And after descent, “you have to walk a lot in most cases, so I don’t think they need to take this into consideration. So many other factors change in air travel that I don’t think this is a significant enough effect to make the effort.”
 

A Known Phenomenon, the Manufacturers Are Aware

This phenomenon has been described previously, including by Dr. King in a 2011 Diabetes Care paper. The new research is among a series of experiments funded by the European Union Aviation Safety Agency in collaboration with the pump manufacturers Medtronic (MiniMed), Tandem (t:slim), and Insulet (Omnipod), primarily aimed at establishing safety parameters for airline pilots with insulin-treated diabetes.

Both the Omnipod DASH and Omnipod 5 User Guides include warnings about unintended insulin delivery during flight, and both advise users to check their blood glucose levels frequently while flying.

In a statement, Jordan Pinsker, MD, Chief Medical Officer at Tandem Diabetes Care, told this news organization, “While it has long been known that routine air travel pressure changes can cause minor fluctuations in insulin pump delivery, the impact of these variations have been found to be generally minor as it relates to glycemic control.”

Dr. Pinsker added that the Tandem Mobi user manual includes a warning related to significant pressure changes in specific air travel situations and offers guidance to disconnect. However, “the t:slim X2 pump’s microdelivery technology limits how much extra insulin can get delivered from air pressure changes due to a mechanism between the tubing and the contents of the bag inside the cartridge.”

Medtronic’s user guide says that the 780G system has not been tested at altitudes higher than 10,150 feet.
 

Hypobaric Chamber Used to Simulate Flight

The study was conducted in vitro, in a hypobaric chamber designed to mimic atmospheric changes during commercial flight. A total of 10 Medtronic MiniMed 780G, 10 Tandem t:slim X2, and six Insulet Omnipod DASH pumps were tested.

The hypobaric chamber was depressurized to 550 mm Hg over a 20-minute ascent, maintained at a 30-minute cruise, followed by a 20-minute descent to ground (750 mm Hg). During the simulated flights, insulin infusion was set at 0.6 units per hour, a rate typical for both adults and children, to allow accurate measurements with multiple flights.

Insulin delivery rates and bubble formation were recorded by attaching infusion sets to open-ended 100 µL capillary tubes against 1-mm grid paper.

Full cartridges — Medtronic: 3 mL, t:slim: 3 mL, and Omnipod: 2 mL — all over-delivered 0.60 units of insulin over a 20-minute ascent compared with delivery at ground level. And during descent, the cartridges under-delivered 0.51 units of insulin.
 

But if There’s Rapid Decompression…

In a separate protocol, insulin infusion sets without pumps were tested in a simulation of rapid decompression. Insulin delivery during both ascent and descent showed statistically significant differences compared with delivery at ground level (both P < .001). In this scenario, fluid delivery was equivalent to 5.6 units of excess insulin.

Dr. King pointed out that while these are rare events, about 40-50 occur annually. One was the widely publicized Alaska Airlines flight in January 2024 when the door fell off in midair.

Dr. Argento said, “The catastrophic decompression is of note, and I would want patients to be aware of this, but it is asking a lot for someone thinking they are going to die to remember to disconnect as it starts.”

The researchers are investigating this phenomenon further in people, including airline pilots.

Dr. King’s research group has been involved in research with Medtronic, Tandem, and Insulet. Dr. Argento has consulted or been on advisory boards for Eli Lilly Diabetes, Dexcom, Diabeloop, Convatec, and Senseonics and served on the speakers’ bureaus for Boehringer Ingelheim, Dexcom, Eli Lilly Diabetes, MannKind, Novo Nordisk, Xeris, and Zealand Pharma.
 

A version of this article appeared on Medscape.com.

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Five Essential Nutrients for Patients on GLP-1s

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Fatigue, nausea, acid reflux, muscle loss, and the dreaded “Ozempic face” are side effects from using glucagon-like peptide 1 (GLP-1) receptor agonists (RAs) such as semaglutide or the dual glucose-dependent insulinotropic polypeptide (GIP)/GLP-1 RA tirzepatide to control blood sugar and promote weight loss. 

But what I’ve learned from working with hundreds of patients on these medications, and others, is that most (if not all) of these side effects can be minimized by ensuring proper nutrition. 

Setting patients up for success requires dietary education and counseling, along with regular monitoring to determine any nutritional deficiencies. Although adequate intake of all the macro and micronutrients is obviously important, there are five nutrients in particular that clinicians should emphasize with their patients on GLP-1 RAs or GIP/GLP-1 RSs.
 

Protein

My patients are probably sick of hearing me talk about protein, but without the constant reinforcement, many of them wouldn’t consume enough of this macronutrient to maintain their baseline lean body mass. The recommended dietary allowance (RDA) for protein (0.8 g/kg bodyweight) doesn’t cut it, especially for older, obese patients, who need closer to 1.0-1.2 g/kg bodyweight to maintain their muscle mass. For example, for a 250-lb patient, I would recommend 114-136 g protein per day. This is equivalent to roughly 15 oz of cooked animal protein. It’s important to note, though, that individuals with kidney disease must limit their protein intake to 0.6-0.8 g/kg bodyweight per day, to avoid overtaxing their kidneys. In this situation, the benefit of increased protein intake does not outweigh the risk of harming the kidneys.

It’s often challenging for patients with suppressed appetites to even think about eating a large hunk of meat or fish, let alone consume it. Plus, eating more than 3-4 oz of protein in one meal can make some patients extremely uncomfortable, owing to the medication’s effect on gastric emptying. This means that daily protein intake must be spread out over multiple mini-meals. 

For patients who need more than 100 g of protein per day, protein powders and premade protein shakes can provide 20-30 g protein to fill in the gaps. Although I always try to promote food first, protein supplements have been game changers for my patients, especially those who find solid food less appealing on the medication, or those who avoid animal protein. 

Clinicians should have their patients monitor changes in their lean body mass using a dual-energy x-ray absorptiometry scan or a bioelectrical impedance scale; this can be a helpful tool in assessing whether protein intake is sufficient. 
 

Fiber

Even my most knowledgeable and compliant patients will experience some constipation. Generally speaking, when you eat less, you will have fewer bowel movements. Combine that with delayed gastric emptying and reduced fiber intake, and you have a perfect storm. Many patients are simply not able to get in the recommended 25-35 g fiber per day through food, because fibrous foods are filling. If they are prioritizing the protein in their meal, they will not have enough room for all the vegetables on their plate. 

To ensure that patients are getting sufficient fiber, clinicians should push consumption of certain vegetables and fruits, such as carrots, broccoli, Brussels sprouts, raspberries, blackberries, and apples, as well as beans and legumes. (Salads are great, but greens like spinach are not as fibrous as one might think.) If the fruit and veggie intake isn’t up to par, a fiber supplement such as psyllium husk can provide an effective boost.
 

 

 

Vitamin B12

Use of these medications is associated with a reduction in vitamin B12 levels, in part because delayed gastric emptying may affect B12 absorption. Low dietary intake of B12 while on the medications can also be to blame, though. The best food sources are animal proteins, so if possible, patients should prioritize having fish, lean meat, eggs, and dairy daily. 

Vegetarians and vegans, who are at an increased risk for deficiency, can incorporate nutritional yeast, an excellent source of vitamin B12, into their daily routine. It is beneficial for patients to get blood work periodically to check on B12 status, because insufficient B12 can contribute to the fatigue patients experience while on the medication.
 

Calcium

Individuals should have calcium on their radar, because weight loss is associated with a decrease in bone mineral density. Adequate intake of the mineral is crucial for optimal bone health, particularly among postmenopausal women and those who are at risk of developing osteoporosis. The RDA for calcium is 1000-1200 mg/d, which an estimated 50% of obese individuals do not take in

Although dairy products are well-known for being rich in calcium, there are other great sources. Dark green leafy vegetables, such as cooked collard greens and spinach, provide nearly 300 mg per cup. Tofu and sardines are also calcium powerhouses. Despite the plethora of calcium-rich foods, however, some patients may need a calcium supplement.
 

Vitamin D

Vitamin D deficiency or insufficiency is common among individuals with obesity, so even before these patients start the medications, supplementation may be warranted. The vitamin’s role in promoting calcium absorption, as well as in bone remodeling, make adequate intake essential for patients experiencing significant weight loss.

Clinicians should emphasize regular consumption of fatty fish, such as salmon, as well as eggs, mushrooms, and vitamin D–fortified milks. But unfortunately, that’s where the list of vitamin D–rich foods ends, so taking a vitamin D supplement will be necessary for many patients.

Regularly monitoring patients on GLP-1 RAs through blood work to check vitamin levels and body composition analysis can be helpful in assessing nutritional status while losing weight. Clinicians can also encourage their patients to work with a registered dietitian who is familiar with these medications, so they can develop optimal eating habits throughout their health journey.

Ms. Hanks, a registered dietitian in New York City, has disclosed no relevant financial relationships.

A version of this article appeared on Medscape.com.

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Fatigue, nausea, acid reflux, muscle loss, and the dreaded “Ozempic face” are side effects from using glucagon-like peptide 1 (GLP-1) receptor agonists (RAs) such as semaglutide or the dual glucose-dependent insulinotropic polypeptide (GIP)/GLP-1 RA tirzepatide to control blood sugar and promote weight loss. 

But what I’ve learned from working with hundreds of patients on these medications, and others, is that most (if not all) of these side effects can be minimized by ensuring proper nutrition. 

Setting patients up for success requires dietary education and counseling, along with regular monitoring to determine any nutritional deficiencies. Although adequate intake of all the macro and micronutrients is obviously important, there are five nutrients in particular that clinicians should emphasize with their patients on GLP-1 RAs or GIP/GLP-1 RSs.
 

Protein

My patients are probably sick of hearing me talk about protein, but without the constant reinforcement, many of them wouldn’t consume enough of this macronutrient to maintain their baseline lean body mass. The recommended dietary allowance (RDA) for protein (0.8 g/kg bodyweight) doesn’t cut it, especially for older, obese patients, who need closer to 1.0-1.2 g/kg bodyweight to maintain their muscle mass. For example, for a 250-lb patient, I would recommend 114-136 g protein per day. This is equivalent to roughly 15 oz of cooked animal protein. It’s important to note, though, that individuals with kidney disease must limit their protein intake to 0.6-0.8 g/kg bodyweight per day, to avoid overtaxing their kidneys. In this situation, the benefit of increased protein intake does not outweigh the risk of harming the kidneys.

It’s often challenging for patients with suppressed appetites to even think about eating a large hunk of meat or fish, let alone consume it. Plus, eating more than 3-4 oz of protein in one meal can make some patients extremely uncomfortable, owing to the medication’s effect on gastric emptying. This means that daily protein intake must be spread out over multiple mini-meals. 

For patients who need more than 100 g of protein per day, protein powders and premade protein shakes can provide 20-30 g protein to fill in the gaps. Although I always try to promote food first, protein supplements have been game changers for my patients, especially those who find solid food less appealing on the medication, or those who avoid animal protein. 

Clinicians should have their patients monitor changes in their lean body mass using a dual-energy x-ray absorptiometry scan or a bioelectrical impedance scale; this can be a helpful tool in assessing whether protein intake is sufficient. 
 

Fiber

Even my most knowledgeable and compliant patients will experience some constipation. Generally speaking, when you eat less, you will have fewer bowel movements. Combine that with delayed gastric emptying and reduced fiber intake, and you have a perfect storm. Many patients are simply not able to get in the recommended 25-35 g fiber per day through food, because fibrous foods are filling. If they are prioritizing the protein in their meal, they will not have enough room for all the vegetables on their plate. 

To ensure that patients are getting sufficient fiber, clinicians should push consumption of certain vegetables and fruits, such as carrots, broccoli, Brussels sprouts, raspberries, blackberries, and apples, as well as beans and legumes. (Salads are great, but greens like spinach are not as fibrous as one might think.) If the fruit and veggie intake isn’t up to par, a fiber supplement such as psyllium husk can provide an effective boost.
 

 

 

Vitamin B12

Use of these medications is associated with a reduction in vitamin B12 levels, in part because delayed gastric emptying may affect B12 absorption. Low dietary intake of B12 while on the medications can also be to blame, though. The best food sources are animal proteins, so if possible, patients should prioritize having fish, lean meat, eggs, and dairy daily. 

Vegetarians and vegans, who are at an increased risk for deficiency, can incorporate nutritional yeast, an excellent source of vitamin B12, into their daily routine. It is beneficial for patients to get blood work periodically to check on B12 status, because insufficient B12 can contribute to the fatigue patients experience while on the medication.
 

Calcium

Individuals should have calcium on their radar, because weight loss is associated with a decrease in bone mineral density. Adequate intake of the mineral is crucial for optimal bone health, particularly among postmenopausal women and those who are at risk of developing osteoporosis. The RDA for calcium is 1000-1200 mg/d, which an estimated 50% of obese individuals do not take in

Although dairy products are well-known for being rich in calcium, there are other great sources. Dark green leafy vegetables, such as cooked collard greens and spinach, provide nearly 300 mg per cup. Tofu and sardines are also calcium powerhouses. Despite the plethora of calcium-rich foods, however, some patients may need a calcium supplement.
 

Vitamin D

Vitamin D deficiency or insufficiency is common among individuals with obesity, so even before these patients start the medications, supplementation may be warranted. The vitamin’s role in promoting calcium absorption, as well as in bone remodeling, make adequate intake essential for patients experiencing significant weight loss.

Clinicians should emphasize regular consumption of fatty fish, such as salmon, as well as eggs, mushrooms, and vitamin D–fortified milks. But unfortunately, that’s where the list of vitamin D–rich foods ends, so taking a vitamin D supplement will be necessary for many patients.

Regularly monitoring patients on GLP-1 RAs through blood work to check vitamin levels and body composition analysis can be helpful in assessing nutritional status while losing weight. Clinicians can also encourage their patients to work with a registered dietitian who is familiar with these medications, so they can develop optimal eating habits throughout their health journey.

Ms. Hanks, a registered dietitian in New York City, has disclosed no relevant financial relationships.

A version of this article appeared on Medscape.com.

Fatigue, nausea, acid reflux, muscle loss, and the dreaded “Ozempic face” are side effects from using glucagon-like peptide 1 (GLP-1) receptor agonists (RAs) such as semaglutide or the dual glucose-dependent insulinotropic polypeptide (GIP)/GLP-1 RA tirzepatide to control blood sugar and promote weight loss. 

But what I’ve learned from working with hundreds of patients on these medications, and others, is that most (if not all) of these side effects can be minimized by ensuring proper nutrition. 

Setting patients up for success requires dietary education and counseling, along with regular monitoring to determine any nutritional deficiencies. Although adequate intake of all the macro and micronutrients is obviously important, there are five nutrients in particular that clinicians should emphasize with their patients on GLP-1 RAs or GIP/GLP-1 RSs.
 

Protein

My patients are probably sick of hearing me talk about protein, but without the constant reinforcement, many of them wouldn’t consume enough of this macronutrient to maintain their baseline lean body mass. The recommended dietary allowance (RDA) for protein (0.8 g/kg bodyweight) doesn’t cut it, especially for older, obese patients, who need closer to 1.0-1.2 g/kg bodyweight to maintain their muscle mass. For example, for a 250-lb patient, I would recommend 114-136 g protein per day. This is equivalent to roughly 15 oz of cooked animal protein. It’s important to note, though, that individuals with kidney disease must limit their protein intake to 0.6-0.8 g/kg bodyweight per day, to avoid overtaxing their kidneys. In this situation, the benefit of increased protein intake does not outweigh the risk of harming the kidneys.

It’s often challenging for patients with suppressed appetites to even think about eating a large hunk of meat or fish, let alone consume it. Plus, eating more than 3-4 oz of protein in one meal can make some patients extremely uncomfortable, owing to the medication’s effect on gastric emptying. This means that daily protein intake must be spread out over multiple mini-meals. 

For patients who need more than 100 g of protein per day, protein powders and premade protein shakes can provide 20-30 g protein to fill in the gaps. Although I always try to promote food first, protein supplements have been game changers for my patients, especially those who find solid food less appealing on the medication, or those who avoid animal protein. 

Clinicians should have their patients monitor changes in their lean body mass using a dual-energy x-ray absorptiometry scan or a bioelectrical impedance scale; this can be a helpful tool in assessing whether protein intake is sufficient. 
 

Fiber

Even my most knowledgeable and compliant patients will experience some constipation. Generally speaking, when you eat less, you will have fewer bowel movements. Combine that with delayed gastric emptying and reduced fiber intake, and you have a perfect storm. Many patients are simply not able to get in the recommended 25-35 g fiber per day through food, because fibrous foods are filling. If they are prioritizing the protein in their meal, they will not have enough room for all the vegetables on their plate. 

To ensure that patients are getting sufficient fiber, clinicians should push consumption of certain vegetables and fruits, such as carrots, broccoli, Brussels sprouts, raspberries, blackberries, and apples, as well as beans and legumes. (Salads are great, but greens like spinach are not as fibrous as one might think.) If the fruit and veggie intake isn’t up to par, a fiber supplement such as psyllium husk can provide an effective boost.
 

 

 

Vitamin B12

Use of these medications is associated with a reduction in vitamin B12 levels, in part because delayed gastric emptying may affect B12 absorption. Low dietary intake of B12 while on the medications can also be to blame, though. The best food sources are animal proteins, so if possible, patients should prioritize having fish, lean meat, eggs, and dairy daily. 

Vegetarians and vegans, who are at an increased risk for deficiency, can incorporate nutritional yeast, an excellent source of vitamin B12, into their daily routine. It is beneficial for patients to get blood work periodically to check on B12 status, because insufficient B12 can contribute to the fatigue patients experience while on the medication.
 

Calcium

Individuals should have calcium on their radar, because weight loss is associated with a decrease in bone mineral density. Adequate intake of the mineral is crucial for optimal bone health, particularly among postmenopausal women and those who are at risk of developing osteoporosis. The RDA for calcium is 1000-1200 mg/d, which an estimated 50% of obese individuals do not take in

Although dairy products are well-known for being rich in calcium, there are other great sources. Dark green leafy vegetables, such as cooked collard greens and spinach, provide nearly 300 mg per cup. Tofu and sardines are also calcium powerhouses. Despite the plethora of calcium-rich foods, however, some patients may need a calcium supplement.
 

Vitamin D

Vitamin D deficiency or insufficiency is common among individuals with obesity, so even before these patients start the medications, supplementation may be warranted. The vitamin’s role in promoting calcium absorption, as well as in bone remodeling, make adequate intake essential for patients experiencing significant weight loss.

Clinicians should emphasize regular consumption of fatty fish, such as salmon, as well as eggs, mushrooms, and vitamin D–fortified milks. But unfortunately, that’s where the list of vitamin D–rich foods ends, so taking a vitamin D supplement will be necessary for many patients.

Regularly monitoring patients on GLP-1 RAs through blood work to check vitamin levels and body composition analysis can be helpful in assessing nutritional status while losing weight. Clinicians can also encourage their patients to work with a registered dietitian who is familiar with these medications, so they can develop optimal eating habits throughout their health journey.

Ms. Hanks, a registered dietitian in New York City, has disclosed no relevant financial relationships.

A version of this article appeared on Medscape.com.

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‘Shed the Lead’ and the Injuries. Should Cath Labs Go Lead-Free?

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Fri, 09/27/2024 - 12:24

“I’d probably be a quadriplegic,” Dean J. Kereiakes, MD, an interventional cardiologist, said when asked what would have happened if two top neurosurgeons at his hospital hadn’t rushed him to the operating room (OR) for a cervical decompression in February this year.

Dr. Kereiakes had orthopedic problems for years due to the heavy lead aprons he wore in the cath lab. He regularly dosed himself with steroids for disc pain so he could stand up straight and continue to do procedures. “Several times a year I’d go on a tapering dose of prednisone of about 10 days to 2 weeks, and this would take care of it.”

But then his luck ran out. “I’m told in retrospect that my gait — the way I walked — was different, and I was also having some myoclonic jerking in my legs when I was going to sleep. I thought it was peculiar, but I didn’t really tie it together that this was an upper tract injury response.”

At a restaurant with his wife, he found himself unable to sign the check. “I couldn’t write my name.” By the next morning, “I had a floppy right foot, and as I turned around to put my scrubs on, everything fell apart. My arms began to not function and my legs — I couldn’t walk.”

Admitted to The Christ Hospital Heart & Vascular Center in Cincinnati — the very hospital he works in — Dr. Kereiakes had CT and MRI scans and consulted with neurosurgeons he counts as friends. He was given extremely high doses of intravenous steroids. “But instead of getting better, the pain came back, and I started posturing — when you posture, it looks like a praying mantis, your arms are flexed up, your wrists are flexed, and your fingers are spasmed together.” His wife and the nurses couldn’t pull his fingers open, “so they rolled me back, and the posturing started to go away.”

This prompted the neurosurgeons to bring him to the OR “by 6 a.m., and they are ‘unzipping me in the back’ to basically get my spinal cord off my spine. I had cord compression at C2-3 and C 6-7.”

Postop, Dr. Kereiakes couldn’t move his right leg and couldn’t close any of his fingers. “You lose control of things like bladder and bowel function — you have a catheter in — and you say to yourself, ‘How am I going to live like this?.’ ”

The quick-thinking of his neurosurgeons prevented permanent paralysis, and after a long 6-month recovery, Dr. Kereiakes is back in the cath lab, performing procedures. But crucially, he will no longer have to wear a lead apron.
 

Ending Careers Early. A Catalyst for Change

Typically, interventional cardiologists, interventional radiologists, electrophysiologists, and others working in labs where they are exposed to ionizing radiation wear lead aprons and garments, such as thyroid collars, leaded caps, and glasses, to protect them during procedures.

Long-term occupational exposure to radiation is linked to cataractsbrain tumorscancers, including leukemia, multiple myelomas, lymphomas, and thyroid cancers; and left-sided breast cancers in women because the aprons don’t always cover the left side of the chest adequately.

Individual states set the standards in terms of the thickness of the lead required, varying from 0.25- to 0.5-mm–lead-equivalent aprons, which reduce exposure by 85%-95%. Radiation safety officers monitor the badges that staff wear to record their radiation exposure and will warn them when their levels are too high.

But — as Dr. Kereiakes freely admits — ambitious interventionalists don’t always take much notice. “They would come and say, ‘Hey your badge is really high,’ and so I would just put it in a drawer and carry on,” he said. “When you are younger, you feel immortal.”

James B. Hermiller Jr., MD, president of the Society for Cardiovascular Angiography & Interventions (SCAI), agrees: “The feeling is that, with lead, you are indestructible, and no one wants to show any weakness.”

Another occupational hazard related to those protective lead aprons was also being ignored, that of orthopedic injury. In surveys done by SCAI, around half of interventional cardiology respondents report cervical, lumbar, hip, knee, or ankle joint injuries.

While Dr. Kereiakes recognizes likely bias — with those afflicted more likely to complete these surveys — he believes that the problem is huge and “is ending careers early.”

“It’s interesting that radiation is at the forefront of protection and occupational safety, but you are much more likely to be taken out of work because of orthopedic injury,” explained Dr. Hermiller, director of Structural Heart Program at Ascension St. Vincent Heart Center in Indianapolis.

His own story “is not as compelling as Dean’s, but 17 years ago, I ruptured a disk in my lower spine and had emergent surgery and I now need a neck surgery.”

Dr. Kereiakes’ case was “a catalyst” for his hospital to investigate, and eventually commit to, the purchase of a new radiation protection system which allows the labs using radiation to effectively go “lead-free.”

Dr. Hermiller’s hospital, too, has purchased multiple radiation protection systems. “If you want to do this job for 30 years, you have to protect yourself early and at all times,” he said.

His focus as SCAI president is to help get these protection systems in place at more hospitals.

But significant challenges remain, not least the cost, which can be $150,000-$200,000 per lab. He estimates that fewer than 10% US hospitals with cath and other labs using radiation have installed such systems.

Most systems are not US Food and Drug Administration (FDA) approved because they are not attached to equipment in the cath lab, something that Nadia Sutton, MD, MPH, chair of the SCAI Women in Innovations committee, said many physicians are not aware of. “The companies [marketing the systems] are telling us that we can ‘shed our lead,’ ” she said. “It could be safe, but we are using the data provided by the companies.”
 

 

 

How Do the Lead-Free Systems Work?

Currently, there are three main radiation protection systems available. The Protego Radiation Protection System (Image Diagnostics), the EggNest Protect (Egg Medical), and the Rampart (Rampart ic).

According to Dr. Kereiakes, they differ somewhat in whether they allow immediate access to the patient or whether you can see and interact with them. He explained that in high-risk procedures, easy access is desirable. “If you get a perforation or tamponade and the patient suddenly goes ‘out,’ you need to be able to get to them quickly, and you can’t be spending a lot of time taking the shielding down.”

Dr. Kereiakes was recovering in the hospital when his colleagues plumped for the EggNest system. He thinks they chose it because it offers visibility and access to the patient and “takes 4-5 minutes, maximum, to set up.” So far, he agrees with the choice but wants to “give it a real, volume-driven try.”

If they are satisfied with the system, the hospital will order six more by the end of the year, he said. A significant financial undertaking, he acknowledged.

Dr. Hermiller cited data for the Rampart system showing a 95% reduction in radiation without any lead. For an average 1-GRAY radiation exposure case, “if you wear lead, you reach the maximum dose of radiation around 850 cases in a year. If you do it with one of these protection systems, in this case Rampart, you can do 14,500 cases in a year. Not that anyone would do that [many].”

The Protego system has very similar data, he noted. The systems protect the operator and whoever is scrubbing in at the table, so those on the other side of the protector still need to wear lead, Dr. Hermiller stressed.

Data for the EggNest Protect are available but are as yet unpublished.

Dr. Hermiller acknowledged that there is still a long way to go in getting hospitals to spend the money on these systems, but he thinks cath lab operators will drive the change.

“At our SCAI meeting this year, the biggest attendance was at a session about a lead-free cath lab environment.”
 

Regulation at the State Level

Despite the excitement among the profession, Dr. Sutton — director of Interventional Cardiology Research in the Division of Cardiovascular Medicine at Vanderbilt University Medical Center, Nashville, Tennessee — still has concerns about the lack of FDA regulation.

There is one newer system, called the Radiaction shield system, that attaches to the existing equipment so that is regulated by the FDA as a class II device, she noted. “But it is my understanding that the Protego, Rampart, and EggNest are Class I Exempt. That is the same category as Band-Aid.”

James Beabout, MBA, chief marketing officer, Egg Medical, confirmed that the EggNest “is classified as a Class I device which does not require FDA approval. That leaves regulation to each state regarding the requirements for protective aprons.” And Mark Hansen, vice president business development, of Image Diagnostics — the manufacturer of the Protego Radiation Protection System — confirmed that “the real governance is at the state level.”

The company petitions the state regulator for an exemption letter to the wearing of lead aprons. “In some cases, the state will come to the site directly and validate the systems integrity and to confirm their decision. Once the exemption is granted, the state sends a document, and it’s the responsibility of the sites’ Radiation Safety Officer (RSO) to change the labs safety process and rules,” Mr. Hansen explained.

“What really makes this work is a real-time dosimetry from Fluke Medical. Staff wear one to two badges that instantly detects exposure,” Mr. Hansen stressed.

Similarly, said Mr. Beabout, Egg Medical has data from over 1000 real-world cases collected using real-time dosimetry (RaySafe i3 system) which demonstrate that it is possible to get some people in the room out of protective aprons, where allowed. They recommend real-time dosimetry anytime people are removing their aprons, “since the patient BMI, x-ray system type/age, and complexity of the case all have a significant effect on the radiation dose in each case.” Their goal is for exposure to be zero or as close to zero as possible, “otherwise we recommend use of protective aprons. With the EggNest, operators can use much lighter aprons (0.125 mm sold by Burlington Medical) than what has traditionally been used, so that is also an option,” he said.

Dr. Hermiller said the SCAI plan is to produce several statements on going lead-free, with all other interested professional societies — such as those representing interventional radiologists and vascular surgeons, as well as all the major cardiology societies.

“We want to make an intellectual foundation for this,” Dr. Hermiller explained. Guidelines “are in the making,” he said, with the expectation that they will be ready by the end of this year or early next year.

SCAI will also work with the 50 US states to facilitate lead-free labs, “as each one has a different way to be approved to go without lead,” he noted.

“This is not going to go away, it’s going to build in force, through the societies,” said Dr. Kereiakes. “It’s a matter of workplace safety.” He doesn’t think that the federal Occupational Health and Safety Administration does much to protect doctors, nurses, and technicians in the cath and other labs.

Dr. Hermiller agreed: “I always say that if we were a GM car plant, they would shut us down.”

Dr. Hermiller also stressed the expense of having doctors and other staff off work with occupation-related injuries. He has already observed that “it’s much easier to recruit cath lab staff to a place where they don’t have to wear lead.”

He anticipates that the next generation of physicians “are going to demand places where they don’t have to wear lead.” He is also hopeful that it will result in more women choosing interventional cardiology: “Women are safe in the cath lab with current lead systems, but if we could move to this, there would be even more women participating.”
 

 

 

Pregnancy Safe in the Cath Lab

Dr. Sutton reiterated his point: “The number-one message that I want to get across is that it is considered safe for the unborn baby, being in the cath lab, under lead,” she said, noting that there are very good data that the amount of lead that is required by states results in negligible radiation exposure to the developing fetus.

She had her children before working in the cath lab, “but I’ve heard from other women: It’s heavy and its sweaty for prolonged periods of time, but it can be done and you can get through it,” she said. Although the promise of radiation protection systems “is exciting, we have to approach this with some level of caution or awareness,” she said. “Cardiologists come from a cardiology background. We are not radiologists who go through a radiology residency, like IRs do. They get a lot of training on radiation exposure and what it means,” Dr. Sutton stressed.

Dr. Kereiakes, for his part, remains enthusiastic. He returned to the cath lab in August, just 6 months after his brush with near quadriplegia. “This is what I’ve spent my life doing and I love doing it, and I’m not ready to quit.”

Dr. Hermiller, Dr. Kereiakes, and Dr. Sutton reported having no relevant financial conflicts of interest.
 

A version of this article appeared on Medscape.com.

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“I’d probably be a quadriplegic,” Dean J. Kereiakes, MD, an interventional cardiologist, said when asked what would have happened if two top neurosurgeons at his hospital hadn’t rushed him to the operating room (OR) for a cervical decompression in February this year.

Dr. Kereiakes had orthopedic problems for years due to the heavy lead aprons he wore in the cath lab. He regularly dosed himself with steroids for disc pain so he could stand up straight and continue to do procedures. “Several times a year I’d go on a tapering dose of prednisone of about 10 days to 2 weeks, and this would take care of it.”

But then his luck ran out. “I’m told in retrospect that my gait — the way I walked — was different, and I was also having some myoclonic jerking in my legs when I was going to sleep. I thought it was peculiar, but I didn’t really tie it together that this was an upper tract injury response.”

At a restaurant with his wife, he found himself unable to sign the check. “I couldn’t write my name.” By the next morning, “I had a floppy right foot, and as I turned around to put my scrubs on, everything fell apart. My arms began to not function and my legs — I couldn’t walk.”

Admitted to The Christ Hospital Heart & Vascular Center in Cincinnati — the very hospital he works in — Dr. Kereiakes had CT and MRI scans and consulted with neurosurgeons he counts as friends. He was given extremely high doses of intravenous steroids. “But instead of getting better, the pain came back, and I started posturing — when you posture, it looks like a praying mantis, your arms are flexed up, your wrists are flexed, and your fingers are spasmed together.” His wife and the nurses couldn’t pull his fingers open, “so they rolled me back, and the posturing started to go away.”

This prompted the neurosurgeons to bring him to the OR “by 6 a.m., and they are ‘unzipping me in the back’ to basically get my spinal cord off my spine. I had cord compression at C2-3 and C 6-7.”

Postop, Dr. Kereiakes couldn’t move his right leg and couldn’t close any of his fingers. “You lose control of things like bladder and bowel function — you have a catheter in — and you say to yourself, ‘How am I going to live like this?.’ ”

The quick-thinking of his neurosurgeons prevented permanent paralysis, and after a long 6-month recovery, Dr. Kereiakes is back in the cath lab, performing procedures. But crucially, he will no longer have to wear a lead apron.
 

Ending Careers Early. A Catalyst for Change

Typically, interventional cardiologists, interventional radiologists, electrophysiologists, and others working in labs where they are exposed to ionizing radiation wear lead aprons and garments, such as thyroid collars, leaded caps, and glasses, to protect them during procedures.

Long-term occupational exposure to radiation is linked to cataractsbrain tumorscancers, including leukemia, multiple myelomas, lymphomas, and thyroid cancers; and left-sided breast cancers in women because the aprons don’t always cover the left side of the chest adequately.

Individual states set the standards in terms of the thickness of the lead required, varying from 0.25- to 0.5-mm–lead-equivalent aprons, which reduce exposure by 85%-95%. Radiation safety officers monitor the badges that staff wear to record their radiation exposure and will warn them when their levels are too high.

But — as Dr. Kereiakes freely admits — ambitious interventionalists don’t always take much notice. “They would come and say, ‘Hey your badge is really high,’ and so I would just put it in a drawer and carry on,” he said. “When you are younger, you feel immortal.”

James B. Hermiller Jr., MD, president of the Society for Cardiovascular Angiography & Interventions (SCAI), agrees: “The feeling is that, with lead, you are indestructible, and no one wants to show any weakness.”

Another occupational hazard related to those protective lead aprons was also being ignored, that of orthopedic injury. In surveys done by SCAI, around half of interventional cardiology respondents report cervical, lumbar, hip, knee, or ankle joint injuries.

While Dr. Kereiakes recognizes likely bias — with those afflicted more likely to complete these surveys — he believes that the problem is huge and “is ending careers early.”

“It’s interesting that radiation is at the forefront of protection and occupational safety, but you are much more likely to be taken out of work because of orthopedic injury,” explained Dr. Hermiller, director of Structural Heart Program at Ascension St. Vincent Heart Center in Indianapolis.

His own story “is not as compelling as Dean’s, but 17 years ago, I ruptured a disk in my lower spine and had emergent surgery and I now need a neck surgery.”

Dr. Kereiakes’ case was “a catalyst” for his hospital to investigate, and eventually commit to, the purchase of a new radiation protection system which allows the labs using radiation to effectively go “lead-free.”

Dr. Hermiller’s hospital, too, has purchased multiple radiation protection systems. “If you want to do this job for 30 years, you have to protect yourself early and at all times,” he said.

His focus as SCAI president is to help get these protection systems in place at more hospitals.

But significant challenges remain, not least the cost, which can be $150,000-$200,000 per lab. He estimates that fewer than 10% US hospitals with cath and other labs using radiation have installed such systems.

Most systems are not US Food and Drug Administration (FDA) approved because they are not attached to equipment in the cath lab, something that Nadia Sutton, MD, MPH, chair of the SCAI Women in Innovations committee, said many physicians are not aware of. “The companies [marketing the systems] are telling us that we can ‘shed our lead,’ ” she said. “It could be safe, but we are using the data provided by the companies.”
 

 

 

How Do the Lead-Free Systems Work?

Currently, there are three main radiation protection systems available. The Protego Radiation Protection System (Image Diagnostics), the EggNest Protect (Egg Medical), and the Rampart (Rampart ic).

According to Dr. Kereiakes, they differ somewhat in whether they allow immediate access to the patient or whether you can see and interact with them. He explained that in high-risk procedures, easy access is desirable. “If you get a perforation or tamponade and the patient suddenly goes ‘out,’ you need to be able to get to them quickly, and you can’t be spending a lot of time taking the shielding down.”

Dr. Kereiakes was recovering in the hospital when his colleagues plumped for the EggNest system. He thinks they chose it because it offers visibility and access to the patient and “takes 4-5 minutes, maximum, to set up.” So far, he agrees with the choice but wants to “give it a real, volume-driven try.”

If they are satisfied with the system, the hospital will order six more by the end of the year, he said. A significant financial undertaking, he acknowledged.

Dr. Hermiller cited data for the Rampart system showing a 95% reduction in radiation without any lead. For an average 1-GRAY radiation exposure case, “if you wear lead, you reach the maximum dose of radiation around 850 cases in a year. If you do it with one of these protection systems, in this case Rampart, you can do 14,500 cases in a year. Not that anyone would do that [many].”

The Protego system has very similar data, he noted. The systems protect the operator and whoever is scrubbing in at the table, so those on the other side of the protector still need to wear lead, Dr. Hermiller stressed.

Data for the EggNest Protect are available but are as yet unpublished.

Dr. Hermiller acknowledged that there is still a long way to go in getting hospitals to spend the money on these systems, but he thinks cath lab operators will drive the change.

“At our SCAI meeting this year, the biggest attendance was at a session about a lead-free cath lab environment.”
 

Regulation at the State Level

Despite the excitement among the profession, Dr. Sutton — director of Interventional Cardiology Research in the Division of Cardiovascular Medicine at Vanderbilt University Medical Center, Nashville, Tennessee — still has concerns about the lack of FDA regulation.

There is one newer system, called the Radiaction shield system, that attaches to the existing equipment so that is regulated by the FDA as a class II device, she noted. “But it is my understanding that the Protego, Rampart, and EggNest are Class I Exempt. That is the same category as Band-Aid.”

James Beabout, MBA, chief marketing officer, Egg Medical, confirmed that the EggNest “is classified as a Class I device which does not require FDA approval. That leaves regulation to each state regarding the requirements for protective aprons.” And Mark Hansen, vice president business development, of Image Diagnostics — the manufacturer of the Protego Radiation Protection System — confirmed that “the real governance is at the state level.”

The company petitions the state regulator for an exemption letter to the wearing of lead aprons. “In some cases, the state will come to the site directly and validate the systems integrity and to confirm their decision. Once the exemption is granted, the state sends a document, and it’s the responsibility of the sites’ Radiation Safety Officer (RSO) to change the labs safety process and rules,” Mr. Hansen explained.

“What really makes this work is a real-time dosimetry from Fluke Medical. Staff wear one to two badges that instantly detects exposure,” Mr. Hansen stressed.

Similarly, said Mr. Beabout, Egg Medical has data from over 1000 real-world cases collected using real-time dosimetry (RaySafe i3 system) which demonstrate that it is possible to get some people in the room out of protective aprons, where allowed. They recommend real-time dosimetry anytime people are removing their aprons, “since the patient BMI, x-ray system type/age, and complexity of the case all have a significant effect on the radiation dose in each case.” Their goal is for exposure to be zero or as close to zero as possible, “otherwise we recommend use of protective aprons. With the EggNest, operators can use much lighter aprons (0.125 mm sold by Burlington Medical) than what has traditionally been used, so that is also an option,” he said.

Dr. Hermiller said the SCAI plan is to produce several statements on going lead-free, with all other interested professional societies — such as those representing interventional radiologists and vascular surgeons, as well as all the major cardiology societies.

“We want to make an intellectual foundation for this,” Dr. Hermiller explained. Guidelines “are in the making,” he said, with the expectation that they will be ready by the end of this year or early next year.

SCAI will also work with the 50 US states to facilitate lead-free labs, “as each one has a different way to be approved to go without lead,” he noted.

“This is not going to go away, it’s going to build in force, through the societies,” said Dr. Kereiakes. “It’s a matter of workplace safety.” He doesn’t think that the federal Occupational Health and Safety Administration does much to protect doctors, nurses, and technicians in the cath and other labs.

Dr. Hermiller agreed: “I always say that if we were a GM car plant, they would shut us down.”

Dr. Hermiller also stressed the expense of having doctors and other staff off work with occupation-related injuries. He has already observed that “it’s much easier to recruit cath lab staff to a place where they don’t have to wear lead.”

He anticipates that the next generation of physicians “are going to demand places where they don’t have to wear lead.” He is also hopeful that it will result in more women choosing interventional cardiology: “Women are safe in the cath lab with current lead systems, but if we could move to this, there would be even more women participating.”
 

 

 

Pregnancy Safe in the Cath Lab

Dr. Sutton reiterated his point: “The number-one message that I want to get across is that it is considered safe for the unborn baby, being in the cath lab, under lead,” she said, noting that there are very good data that the amount of lead that is required by states results in negligible radiation exposure to the developing fetus.

She had her children before working in the cath lab, “but I’ve heard from other women: It’s heavy and its sweaty for prolonged periods of time, but it can be done and you can get through it,” she said. Although the promise of radiation protection systems “is exciting, we have to approach this with some level of caution or awareness,” she said. “Cardiologists come from a cardiology background. We are not radiologists who go through a radiology residency, like IRs do. They get a lot of training on radiation exposure and what it means,” Dr. Sutton stressed.

Dr. Kereiakes, for his part, remains enthusiastic. He returned to the cath lab in August, just 6 months after his brush with near quadriplegia. “This is what I’ve spent my life doing and I love doing it, and I’m not ready to quit.”

Dr. Hermiller, Dr. Kereiakes, and Dr. Sutton reported having no relevant financial conflicts of interest.
 

A version of this article appeared on Medscape.com.

“I’d probably be a quadriplegic,” Dean J. Kereiakes, MD, an interventional cardiologist, said when asked what would have happened if two top neurosurgeons at his hospital hadn’t rushed him to the operating room (OR) for a cervical decompression in February this year.

Dr. Kereiakes had orthopedic problems for years due to the heavy lead aprons he wore in the cath lab. He regularly dosed himself with steroids for disc pain so he could stand up straight and continue to do procedures. “Several times a year I’d go on a tapering dose of prednisone of about 10 days to 2 weeks, and this would take care of it.”

But then his luck ran out. “I’m told in retrospect that my gait — the way I walked — was different, and I was also having some myoclonic jerking in my legs when I was going to sleep. I thought it was peculiar, but I didn’t really tie it together that this was an upper tract injury response.”

At a restaurant with his wife, he found himself unable to sign the check. “I couldn’t write my name.” By the next morning, “I had a floppy right foot, and as I turned around to put my scrubs on, everything fell apart. My arms began to not function and my legs — I couldn’t walk.”

Admitted to The Christ Hospital Heart & Vascular Center in Cincinnati — the very hospital he works in — Dr. Kereiakes had CT and MRI scans and consulted with neurosurgeons he counts as friends. He was given extremely high doses of intravenous steroids. “But instead of getting better, the pain came back, and I started posturing — when you posture, it looks like a praying mantis, your arms are flexed up, your wrists are flexed, and your fingers are spasmed together.” His wife and the nurses couldn’t pull his fingers open, “so they rolled me back, and the posturing started to go away.”

This prompted the neurosurgeons to bring him to the OR “by 6 a.m., and they are ‘unzipping me in the back’ to basically get my spinal cord off my spine. I had cord compression at C2-3 and C 6-7.”

Postop, Dr. Kereiakes couldn’t move his right leg and couldn’t close any of his fingers. “You lose control of things like bladder and bowel function — you have a catheter in — and you say to yourself, ‘How am I going to live like this?.’ ”

The quick-thinking of his neurosurgeons prevented permanent paralysis, and after a long 6-month recovery, Dr. Kereiakes is back in the cath lab, performing procedures. But crucially, he will no longer have to wear a lead apron.
 

Ending Careers Early. A Catalyst for Change

Typically, interventional cardiologists, interventional radiologists, electrophysiologists, and others working in labs where they are exposed to ionizing radiation wear lead aprons and garments, such as thyroid collars, leaded caps, and glasses, to protect them during procedures.

Long-term occupational exposure to radiation is linked to cataractsbrain tumorscancers, including leukemia, multiple myelomas, lymphomas, and thyroid cancers; and left-sided breast cancers in women because the aprons don’t always cover the left side of the chest adequately.

Individual states set the standards in terms of the thickness of the lead required, varying from 0.25- to 0.5-mm–lead-equivalent aprons, which reduce exposure by 85%-95%. Radiation safety officers monitor the badges that staff wear to record their radiation exposure and will warn them when their levels are too high.

But — as Dr. Kereiakes freely admits — ambitious interventionalists don’t always take much notice. “They would come and say, ‘Hey your badge is really high,’ and so I would just put it in a drawer and carry on,” he said. “When you are younger, you feel immortal.”

James B. Hermiller Jr., MD, president of the Society for Cardiovascular Angiography & Interventions (SCAI), agrees: “The feeling is that, with lead, you are indestructible, and no one wants to show any weakness.”

Another occupational hazard related to those protective lead aprons was also being ignored, that of orthopedic injury. In surveys done by SCAI, around half of interventional cardiology respondents report cervical, lumbar, hip, knee, or ankle joint injuries.

While Dr. Kereiakes recognizes likely bias — with those afflicted more likely to complete these surveys — he believes that the problem is huge and “is ending careers early.”

“It’s interesting that radiation is at the forefront of protection and occupational safety, but you are much more likely to be taken out of work because of orthopedic injury,” explained Dr. Hermiller, director of Structural Heart Program at Ascension St. Vincent Heart Center in Indianapolis.

His own story “is not as compelling as Dean’s, but 17 years ago, I ruptured a disk in my lower spine and had emergent surgery and I now need a neck surgery.”

Dr. Kereiakes’ case was “a catalyst” for his hospital to investigate, and eventually commit to, the purchase of a new radiation protection system which allows the labs using radiation to effectively go “lead-free.”

Dr. Hermiller’s hospital, too, has purchased multiple radiation protection systems. “If you want to do this job for 30 years, you have to protect yourself early and at all times,” he said.

His focus as SCAI president is to help get these protection systems in place at more hospitals.

But significant challenges remain, not least the cost, which can be $150,000-$200,000 per lab. He estimates that fewer than 10% US hospitals with cath and other labs using radiation have installed such systems.

Most systems are not US Food and Drug Administration (FDA) approved because they are not attached to equipment in the cath lab, something that Nadia Sutton, MD, MPH, chair of the SCAI Women in Innovations committee, said many physicians are not aware of. “The companies [marketing the systems] are telling us that we can ‘shed our lead,’ ” she said. “It could be safe, but we are using the data provided by the companies.”
 

 

 

How Do the Lead-Free Systems Work?

Currently, there are three main radiation protection systems available. The Protego Radiation Protection System (Image Diagnostics), the EggNest Protect (Egg Medical), and the Rampart (Rampart ic).

According to Dr. Kereiakes, they differ somewhat in whether they allow immediate access to the patient or whether you can see and interact with them. He explained that in high-risk procedures, easy access is desirable. “If you get a perforation or tamponade and the patient suddenly goes ‘out,’ you need to be able to get to them quickly, and you can’t be spending a lot of time taking the shielding down.”

Dr. Kereiakes was recovering in the hospital when his colleagues plumped for the EggNest system. He thinks they chose it because it offers visibility and access to the patient and “takes 4-5 minutes, maximum, to set up.” So far, he agrees with the choice but wants to “give it a real, volume-driven try.”

If they are satisfied with the system, the hospital will order six more by the end of the year, he said. A significant financial undertaking, he acknowledged.

Dr. Hermiller cited data for the Rampart system showing a 95% reduction in radiation without any lead. For an average 1-GRAY radiation exposure case, “if you wear lead, you reach the maximum dose of radiation around 850 cases in a year. If you do it with one of these protection systems, in this case Rampart, you can do 14,500 cases in a year. Not that anyone would do that [many].”

The Protego system has very similar data, he noted. The systems protect the operator and whoever is scrubbing in at the table, so those on the other side of the protector still need to wear lead, Dr. Hermiller stressed.

Data for the EggNest Protect are available but are as yet unpublished.

Dr. Hermiller acknowledged that there is still a long way to go in getting hospitals to spend the money on these systems, but he thinks cath lab operators will drive the change.

“At our SCAI meeting this year, the biggest attendance was at a session about a lead-free cath lab environment.”
 

Regulation at the State Level

Despite the excitement among the profession, Dr. Sutton — director of Interventional Cardiology Research in the Division of Cardiovascular Medicine at Vanderbilt University Medical Center, Nashville, Tennessee — still has concerns about the lack of FDA regulation.

There is one newer system, called the Radiaction shield system, that attaches to the existing equipment so that is regulated by the FDA as a class II device, she noted. “But it is my understanding that the Protego, Rampart, and EggNest are Class I Exempt. That is the same category as Band-Aid.”

James Beabout, MBA, chief marketing officer, Egg Medical, confirmed that the EggNest “is classified as a Class I device which does not require FDA approval. That leaves regulation to each state regarding the requirements for protective aprons.” And Mark Hansen, vice president business development, of Image Diagnostics — the manufacturer of the Protego Radiation Protection System — confirmed that “the real governance is at the state level.”

The company petitions the state regulator for an exemption letter to the wearing of lead aprons. “In some cases, the state will come to the site directly and validate the systems integrity and to confirm their decision. Once the exemption is granted, the state sends a document, and it’s the responsibility of the sites’ Radiation Safety Officer (RSO) to change the labs safety process and rules,” Mr. Hansen explained.

“What really makes this work is a real-time dosimetry from Fluke Medical. Staff wear one to two badges that instantly detects exposure,” Mr. Hansen stressed.

Similarly, said Mr. Beabout, Egg Medical has data from over 1000 real-world cases collected using real-time dosimetry (RaySafe i3 system) which demonstrate that it is possible to get some people in the room out of protective aprons, where allowed. They recommend real-time dosimetry anytime people are removing their aprons, “since the patient BMI, x-ray system type/age, and complexity of the case all have a significant effect on the radiation dose in each case.” Their goal is for exposure to be zero or as close to zero as possible, “otherwise we recommend use of protective aprons. With the EggNest, operators can use much lighter aprons (0.125 mm sold by Burlington Medical) than what has traditionally been used, so that is also an option,” he said.

Dr. Hermiller said the SCAI plan is to produce several statements on going lead-free, with all other interested professional societies — such as those representing interventional radiologists and vascular surgeons, as well as all the major cardiology societies.

“We want to make an intellectual foundation for this,” Dr. Hermiller explained. Guidelines “are in the making,” he said, with the expectation that they will be ready by the end of this year or early next year.

SCAI will also work with the 50 US states to facilitate lead-free labs, “as each one has a different way to be approved to go without lead,” he noted.

“This is not going to go away, it’s going to build in force, through the societies,” said Dr. Kereiakes. “It’s a matter of workplace safety.” He doesn’t think that the federal Occupational Health and Safety Administration does much to protect doctors, nurses, and technicians in the cath and other labs.

Dr. Hermiller agreed: “I always say that if we were a GM car plant, they would shut us down.”

Dr. Hermiller also stressed the expense of having doctors and other staff off work with occupation-related injuries. He has already observed that “it’s much easier to recruit cath lab staff to a place where they don’t have to wear lead.”

He anticipates that the next generation of physicians “are going to demand places where they don’t have to wear lead.” He is also hopeful that it will result in more women choosing interventional cardiology: “Women are safe in the cath lab with current lead systems, but if we could move to this, there would be even more women participating.”
 

 

 

Pregnancy Safe in the Cath Lab

Dr. Sutton reiterated his point: “The number-one message that I want to get across is that it is considered safe for the unborn baby, being in the cath lab, under lead,” she said, noting that there are very good data that the amount of lead that is required by states results in negligible radiation exposure to the developing fetus.

She had her children before working in the cath lab, “but I’ve heard from other women: It’s heavy and its sweaty for prolonged periods of time, but it can be done and you can get through it,” she said. Although the promise of radiation protection systems “is exciting, we have to approach this with some level of caution or awareness,” she said. “Cardiologists come from a cardiology background. We are not radiologists who go through a radiology residency, like IRs do. They get a lot of training on radiation exposure and what it means,” Dr. Sutton stressed.

Dr. Kereiakes, for his part, remains enthusiastic. He returned to the cath lab in August, just 6 months after his brush with near quadriplegia. “This is what I’ve spent my life doing and I love doing it, and I’m not ready to quit.”

Dr. Hermiller, Dr. Kereiakes, and Dr. Sutton reported having no relevant financial conflicts of interest.
 

A version of this article appeared on Medscape.com.

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