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News and Views that Matter to Rheumatologists
gambling
compulsive behaviors
ammunition
assault rifle
black jack
Boko Haram
bondage
child abuse
cocaine
Daech
drug paraphernalia
explosion
gun
human trafficking
ISIL
ISIS
Islamic caliphate
Islamic state
mixed martial arts
MMA
molestation
national rifle association
NRA
nsfw
pedophile
pedophilia
poker
porn
pornography
psychedelic drug
recreational drug
sex slave rings
slot machine
terrorism
terrorist
Texas hold 'em
UFC
substance abuse
abuseed
abuseer
abusees
abuseing
abusely
abuses
aeolus
aeolused
aeoluser
aeoluses
aeolusing
aeolusly
aeoluss
ahole
aholeed
aholeer
aholees
aholeing
aholely
aholes
alcohol
alcoholed
alcoholer
alcoholes
alcoholing
alcoholly
alcohols
allman
allmaned
allmaner
allmanes
allmaning
allmanly
allmans
alted
altes
alting
altly
alts
analed
analer
anales
analing
anally
analprobe
analprobeed
analprobeer
analprobees
analprobeing
analprobely
analprobes
anals
anilingus
anilingused
anilinguser
anilinguses
anilingusing
anilingusly
anilinguss
anus
anused
anuser
anuses
anusing
anusly
anuss
areola
areolaed
areolaer
areolaes
areolaing
areolaly
areolas
areole
areoleed
areoleer
areolees
areoleing
areolely
areoles
arian
arianed
arianer
arianes
arianing
arianly
arians
aryan
aryaned
aryaner
aryanes
aryaning
aryanly
aryans
asiaed
asiaer
asiaes
asiaing
asialy
asias
ass
ass hole
ass lick
ass licked
ass licker
ass lickes
ass licking
ass lickly
ass licks
assbang
assbanged
assbangeded
assbangeder
assbangedes
assbangeding
assbangedly
assbangeds
assbanger
assbanges
assbanging
assbangly
assbangs
assbangsed
assbangser
assbangses
assbangsing
assbangsly
assbangss
assed
asser
asses
assesed
asseser
asseses
assesing
assesly
assess
assfuck
assfucked
assfucker
assfuckered
assfuckerer
assfuckeres
assfuckering
assfuckerly
assfuckers
assfuckes
assfucking
assfuckly
assfucks
asshat
asshated
asshater
asshates
asshating
asshatly
asshats
assholeed
assholeer
assholees
assholeing
assholely
assholes
assholesed
assholeser
assholeses
assholesing
assholesly
assholess
assing
assly
assmaster
assmastered
assmasterer
assmasteres
assmastering
assmasterly
assmasters
assmunch
assmunched
assmuncher
assmunches
assmunching
assmunchly
assmunchs
asss
asswipe
asswipeed
asswipeer
asswipees
asswipeing
asswipely
asswipes
asswipesed
asswipeser
asswipeses
asswipesing
asswipesly
asswipess
azz
azzed
azzer
azzes
azzing
azzly
azzs
babeed
babeer
babees
babeing
babely
babes
babesed
babeser
babeses
babesing
babesly
babess
ballsac
ballsaced
ballsacer
ballsaces
ballsacing
ballsack
ballsacked
ballsacker
ballsackes
ballsacking
ballsackly
ballsacks
ballsacly
ballsacs
ballsed
ballser
ballses
ballsing
ballsly
ballss
barf
barfed
barfer
barfes
barfing
barfly
barfs
bastard
bastarded
bastarder
bastardes
bastarding
bastardly
bastards
bastardsed
bastardser
bastardses
bastardsing
bastardsly
bastardss
bawdy
bawdyed
bawdyer
bawdyes
bawdying
bawdyly
bawdys
beaner
beanered
beanerer
beaneres
beanering
beanerly
beaners
beardedclam
beardedclamed
beardedclamer
beardedclames
beardedclaming
beardedclamly
beardedclams
beastiality
beastialityed
beastialityer
beastialityes
beastialitying
beastialityly
beastialitys
beatch
beatched
beatcher
beatches
beatching
beatchly
beatchs
beater
beatered
beaterer
beateres
beatering
beaterly
beaters
beered
beerer
beeres
beering
beerly
beeyotch
beeyotched
beeyotcher
beeyotches
beeyotching
beeyotchly
beeyotchs
beotch
beotched
beotcher
beotches
beotching
beotchly
beotchs
biatch
biatched
biatcher
biatches
biatching
biatchly
biatchs
big tits
big titsed
big titser
big titses
big titsing
big titsly
big titss
bigtits
bigtitsed
bigtitser
bigtitses
bigtitsing
bigtitsly
bigtitss
bimbo
bimboed
bimboer
bimboes
bimboing
bimboly
bimbos
bisexualed
bisexualer
bisexuales
bisexualing
bisexually
bisexuals
bitch
bitched
bitcheded
bitcheder
bitchedes
bitcheding
bitchedly
bitcheds
bitcher
bitches
bitchesed
bitcheser
bitcheses
bitchesing
bitchesly
bitchess
bitching
bitchly
bitchs
bitchy
bitchyed
bitchyer
bitchyes
bitchying
bitchyly
bitchys
bleached
bleacher
bleaches
bleaching
bleachly
bleachs
blow job
blow jobed
blow jober
blow jobes
blow jobing
blow jobly
blow jobs
blowed
blower
blowes
blowing
blowjob
blowjobed
blowjober
blowjobes
blowjobing
blowjobly
blowjobs
blowjobsed
blowjobser
blowjobses
blowjobsing
blowjobsly
blowjobss
blowly
blows
boink
boinked
boinker
boinkes
boinking
boinkly
boinks
bollock
bollocked
bollocker
bollockes
bollocking
bollockly
bollocks
bollocksed
bollockser
bollockses
bollocksing
bollocksly
bollockss
bollok
bolloked
bolloker
bollokes
bolloking
bollokly
bolloks
boner
bonered
bonerer
boneres
bonering
bonerly
boners
bonersed
bonerser
bonerses
bonersing
bonersly
bonerss
bong
bonged
bonger
bonges
bonging
bongly
bongs
boob
boobed
boober
boobes
boobies
boobiesed
boobieser
boobieses
boobiesing
boobiesly
boobiess
boobing
boobly
boobs
boobsed
boobser
boobses
boobsing
boobsly
boobss
booby
boobyed
boobyer
boobyes
boobying
boobyly
boobys
booger
boogered
boogerer
boogeres
boogering
boogerly
boogers
bookie
bookieed
bookieer
bookiees
bookieing
bookiely
bookies
bootee
booteeed
booteeer
booteees
booteeing
booteely
bootees
bootie
bootieed
bootieer
bootiees
bootieing
bootiely
booties
booty
bootyed
bootyer
bootyes
bootying
bootyly
bootys
boozeed
boozeer
boozees
boozeing
boozely
boozer
boozered
boozerer
boozeres
boozering
boozerly
boozers
boozes
boozy
boozyed
boozyer
boozyes
boozying
boozyly
boozys
bosomed
bosomer
bosomes
bosoming
bosomly
bosoms
bosomy
bosomyed
bosomyer
bosomyes
bosomying
bosomyly
bosomys
bugger
buggered
buggerer
buggeres
buggering
buggerly
buggers
bukkake
bukkakeed
bukkakeer
bukkakees
bukkakeing
bukkakely
bukkakes
bull shit
bull shited
bull shiter
bull shites
bull shiting
bull shitly
bull shits
bullshit
bullshited
bullshiter
bullshites
bullshiting
bullshitly
bullshits
bullshitsed
bullshitser
bullshitses
bullshitsing
bullshitsly
bullshitss
bullshitted
bullshitteded
bullshitteder
bullshittedes
bullshitteding
bullshittedly
bullshitteds
bullturds
bullturdsed
bullturdser
bullturdses
bullturdsing
bullturdsly
bullturdss
bung
bunged
bunger
bunges
bunging
bungly
bungs
busty
bustyed
bustyer
bustyes
bustying
bustyly
bustys
butt
butt fuck
butt fucked
butt fucker
butt fuckes
butt fucking
butt fuckly
butt fucks
butted
buttes
buttfuck
buttfucked
buttfucker
buttfuckered
buttfuckerer
buttfuckeres
buttfuckering
buttfuckerly
buttfuckers
buttfuckes
buttfucking
buttfuckly
buttfucks
butting
buttly
buttplug
buttpluged
buttpluger
buttpluges
buttpluging
buttplugly
buttplugs
butts
caca
cacaed
cacaer
cacaes
cacaing
cacaly
cacas
cahone
cahoneed
cahoneer
cahonees
cahoneing
cahonely
cahones
cameltoe
cameltoeed
cameltoeer
cameltoees
cameltoeing
cameltoely
cameltoes
carpetmuncher
carpetmunchered
carpetmuncherer
carpetmuncheres
carpetmunchering
carpetmuncherly
carpetmunchers
cawk
cawked
cawker
cawkes
cawking
cawkly
cawks
chinc
chinced
chincer
chinces
chincing
chincly
chincs
chincsed
chincser
chincses
chincsing
chincsly
chincss
chink
chinked
chinker
chinkes
chinking
chinkly
chinks
chode
chodeed
chodeer
chodees
chodeing
chodely
chodes
chodesed
chodeser
chodeses
chodesing
chodesly
chodess
clit
clited
cliter
clites
cliting
clitly
clitoris
clitorised
clitoriser
clitorises
clitorising
clitorisly
clitoriss
clitorus
clitorused
clitoruser
clitoruses
clitorusing
clitorusly
clitoruss
clits
clitsed
clitser
clitses
clitsing
clitsly
clitss
clitty
clittyed
clittyer
clittyes
clittying
clittyly
clittys
cocain
cocaine
cocained
cocaineed
cocaineer
cocainees
cocaineing
cocainely
cocainer
cocaines
cocaining
cocainly
cocains
cock
cock sucker
cock suckered
cock suckerer
cock suckeres
cock suckering
cock suckerly
cock suckers
cockblock
cockblocked
cockblocker
cockblockes
cockblocking
cockblockly
cockblocks
cocked
cocker
cockes
cockholster
cockholstered
cockholsterer
cockholsteres
cockholstering
cockholsterly
cockholsters
cocking
cockknocker
cockknockered
cockknockerer
cockknockeres
cockknockering
cockknockerly
cockknockers
cockly
cocks
cocksed
cockser
cockses
cocksing
cocksly
cocksmoker
cocksmokered
cocksmokerer
cocksmokeres
cocksmokering
cocksmokerly
cocksmokers
cockss
cocksucker
cocksuckered
cocksuckerer
cocksuckeres
cocksuckering
cocksuckerly
cocksuckers
coital
coitaled
coitaler
coitales
coitaling
coitally
coitals
commie
commieed
commieer
commiees
commieing
commiely
commies
condomed
condomer
condomes
condoming
condomly
condoms
coon
cooned
cooner
coones
cooning
coonly
coons
coonsed
coonser
coonses
coonsing
coonsly
coonss
corksucker
corksuckered
corksuckerer
corksuckeres
corksuckering
corksuckerly
corksuckers
cracked
crackwhore
crackwhoreed
crackwhoreer
crackwhorees
crackwhoreing
crackwhorely
crackwhores
crap
craped
craper
crapes
craping
craply
crappy
crappyed
crappyer
crappyes
crappying
crappyly
crappys
cum
cumed
cumer
cumes
cuming
cumly
cummin
cummined
cumminer
cummines
cumming
cumminged
cumminger
cumminges
cumminging
cummingly
cummings
cummining
cumminly
cummins
cums
cumshot
cumshoted
cumshoter
cumshotes
cumshoting
cumshotly
cumshots
cumshotsed
cumshotser
cumshotses
cumshotsing
cumshotsly
cumshotss
cumslut
cumsluted
cumsluter
cumslutes
cumsluting
cumslutly
cumsluts
cumstain
cumstained
cumstainer
cumstaines
cumstaining
cumstainly
cumstains
cunilingus
cunilingused
cunilinguser
cunilinguses
cunilingusing
cunilingusly
cunilinguss
cunnilingus
cunnilingused
cunnilinguser
cunnilinguses
cunnilingusing
cunnilingusly
cunnilinguss
cunny
cunnyed
cunnyer
cunnyes
cunnying
cunnyly
cunnys
cunt
cunted
cunter
cuntes
cuntface
cuntfaceed
cuntfaceer
cuntfacees
cuntfaceing
cuntfacely
cuntfaces
cunthunter
cunthuntered
cunthunterer
cunthunteres
cunthuntering
cunthunterly
cunthunters
cunting
cuntlick
cuntlicked
cuntlicker
cuntlickered
cuntlickerer
cuntlickeres
cuntlickering
cuntlickerly
cuntlickers
cuntlickes
cuntlicking
cuntlickly
cuntlicks
cuntly
cunts
cuntsed
cuntser
cuntses
cuntsing
cuntsly
cuntss
dago
dagoed
dagoer
dagoes
dagoing
dagoly
dagos
dagosed
dagoser
dagoses
dagosing
dagosly
dagoss
dammit
dammited
dammiter
dammites
dammiting
dammitly
dammits
damn
damned
damneded
damneder
damnedes
damneding
damnedly
damneds
damner
damnes
damning
damnit
damnited
damniter
damnites
damniting
damnitly
damnits
damnly
damns
dick
dickbag
dickbaged
dickbager
dickbages
dickbaging
dickbagly
dickbags
dickdipper
dickdippered
dickdipperer
dickdipperes
dickdippering
dickdipperly
dickdippers
dicked
dicker
dickes
dickface
dickfaceed
dickfaceer
dickfacees
dickfaceing
dickfacely
dickfaces
dickflipper
dickflippered
dickflipperer
dickflipperes
dickflippering
dickflipperly
dickflippers
dickhead
dickheaded
dickheader
dickheades
dickheading
dickheadly
dickheads
dickheadsed
dickheadser
dickheadses
dickheadsing
dickheadsly
dickheadss
dicking
dickish
dickished
dickisher
dickishes
dickishing
dickishly
dickishs
dickly
dickripper
dickrippered
dickripperer
dickripperes
dickrippering
dickripperly
dickrippers
dicks
dicksipper
dicksippered
dicksipperer
dicksipperes
dicksippering
dicksipperly
dicksippers
dickweed
dickweeded
dickweeder
dickweedes
dickweeding
dickweedly
dickweeds
dickwhipper
dickwhippered
dickwhipperer
dickwhipperes
dickwhippering
dickwhipperly
dickwhippers
dickzipper
dickzippered
dickzipperer
dickzipperes
dickzippering
dickzipperly
dickzippers
diddle
diddleed
diddleer
diddlees
diddleing
diddlely
diddles
dike
dikeed
dikeer
dikees
dikeing
dikely
dikes
dildo
dildoed
dildoer
dildoes
dildoing
dildoly
dildos
dildosed
dildoser
dildoses
dildosing
dildosly
dildoss
diligaf
diligafed
diligafer
diligafes
diligafing
diligafly
diligafs
dillweed
dillweeded
dillweeder
dillweedes
dillweeding
dillweedly
dillweeds
dimwit
dimwited
dimwiter
dimwites
dimwiting
dimwitly
dimwits
dingle
dingleed
dingleer
dinglees
dingleing
dinglely
dingles
dipship
dipshiped
dipshiper
dipshipes
dipshiping
dipshiply
dipships
dizzyed
dizzyer
dizzyes
dizzying
dizzyly
dizzys
doggiestyleed
doggiestyleer
doggiestylees
doggiestyleing
doggiestylely
doggiestyles
doggystyleed
doggystyleer
doggystylees
doggystyleing
doggystylely
doggystyles
dong
donged
donger
donges
donging
dongly
dongs
doofus
doofused
doofuser
doofuses
doofusing
doofusly
doofuss
doosh
dooshed
doosher
dooshes
dooshing
dooshly
dooshs
dopeyed
dopeyer
dopeyes
dopeying
dopeyly
dopeys
douchebag
douchebaged
douchebager
douchebages
douchebaging
douchebagly
douchebags
douchebagsed
douchebagser
douchebagses
douchebagsing
douchebagsly
douchebagss
doucheed
doucheer
douchees
doucheing
douchely
douches
douchey
doucheyed
doucheyer
doucheyes
doucheying
doucheyly
doucheys
drunk
drunked
drunker
drunkes
drunking
drunkly
drunks
dumass
dumassed
dumasser
dumasses
dumassing
dumassly
dumasss
dumbass
dumbassed
dumbasser
dumbasses
dumbassesed
dumbasseser
dumbasseses
dumbassesing
dumbassesly
dumbassess
dumbassing
dumbassly
dumbasss
dummy
dummyed
dummyer
dummyes
dummying
dummyly
dummys
dyke
dykeed
dykeer
dykees
dykeing
dykely
dykes
dykesed
dykeser
dykeses
dykesing
dykesly
dykess
erotic
eroticed
eroticer
erotices
eroticing
eroticly
erotics
extacy
extacyed
extacyer
extacyes
extacying
extacyly
extacys
extasy
extasyed
extasyer
extasyes
extasying
extasyly
extasys
fack
facked
facker
fackes
facking
fackly
facks
fag
faged
fager
fages
fagg
fagged
faggeded
faggeder
faggedes
faggeding
faggedly
faggeds
fagger
fagges
fagging
faggit
faggited
faggiter
faggites
faggiting
faggitly
faggits
faggly
faggot
faggoted
faggoter
faggotes
faggoting
faggotly
faggots
faggs
faging
fagly
fagot
fagoted
fagoter
fagotes
fagoting
fagotly
fagots
fags
fagsed
fagser
fagses
fagsing
fagsly
fagss
faig
faiged
faiger
faiges
faiging
faigly
faigs
faigt
faigted
faigter
faigtes
faigting
faigtly
faigts
fannybandit
fannybandited
fannybanditer
fannybandites
fannybanditing
fannybanditly
fannybandits
farted
farter
fartes
farting
fartknocker
fartknockered
fartknockerer
fartknockeres
fartknockering
fartknockerly
fartknockers
fartly
farts
felch
felched
felcher
felchered
felcherer
felcheres
felchering
felcherly
felchers
felches
felching
felchinged
felchinger
felchinges
felchinging
felchingly
felchings
felchly
felchs
fellate
fellateed
fellateer
fellatees
fellateing
fellately
fellates
fellatio
fellatioed
fellatioer
fellatioes
fellatioing
fellatioly
fellatios
feltch
feltched
feltcher
feltchered
feltcherer
feltcheres
feltchering
feltcherly
feltchers
feltches
feltching
feltchly
feltchs
feom
feomed
feomer
feomes
feoming
feomly
feoms
fisted
fisteded
fisteder
fistedes
fisteding
fistedly
fisteds
fisting
fistinged
fistinger
fistinges
fistinging
fistingly
fistings
fisty
fistyed
fistyer
fistyes
fistying
fistyly
fistys
floozy
floozyed
floozyer
floozyes
floozying
floozyly
floozys
foad
foaded
foader
foades
foading
foadly
foads
fondleed
fondleer
fondlees
fondleing
fondlely
fondles
foobar
foobared
foobarer
foobares
foobaring
foobarly
foobars
freex
freexed
freexer
freexes
freexing
freexly
freexs
frigg
frigga
friggaed
friggaer
friggaes
friggaing
friggaly
friggas
frigged
frigger
frigges
frigging
friggly
friggs
fubar
fubared
fubarer
fubares
fubaring
fubarly
fubars
fuck
fuckass
fuckassed
fuckasser
fuckasses
fuckassing
fuckassly
fuckasss
fucked
fuckeded
fuckeder
fuckedes
fuckeding
fuckedly
fuckeds
fucker
fuckered
fuckerer
fuckeres
fuckering
fuckerly
fuckers
fuckes
fuckface
fuckfaceed
fuckfaceer
fuckfacees
fuckfaceing
fuckfacely
fuckfaces
fuckin
fuckined
fuckiner
fuckines
fucking
fuckinged
fuckinger
fuckinges
fuckinging
fuckingly
fuckings
fuckining
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The leading independent newspaper covering rheumatology news and commentary.
Time to Lung Disease in Patients With Dermatomyositis Subtype Estimated
TOPLINE:
The time interval between onset of interstitial lung disease (ILD) and diagnosis of anti–melanoma differentiation-associated gene 5 (MDA5) antibody-positive dermatomyositis (DM) “has not been well described,” the authors say.
METHODOLOGY:
- , with the former having a particularly high mortality rate.
- In this retrospective cohort study using electronic medical records, researchers evaluated 774 patients with DM between 2008 and 2023 to learn more about the time interval between ILD and the time of an MDA5 antibody-positive DM diagnosis, which has not been well described.
- The primary outcome was ILD diagnosis and time in days between documented ILD and MDA5 antibody-positive DM diagnoses.
TAKEAWAY:
- Overall, 14 patients with DM (1.8%) were diagnosed with MDA5 antibody-positive DM in dermatology, rheumatology, or pulmonology departments (nine women and five men; age, 24-77 years; 79% were White and 7% were Black).
- ILD was diagnosed in 9 of the 14 patients (64%); 6 of the 14 (43%) met the criteria for RPILD. Two cases were diagnosed concurrently and two prior to MDA5 antibody-positive DM diagnosis.
- The median time between ILD and MDA5 antibody-positive DM diagnoses was 163 days.
- Gottron papules/sign and midfacial erythema were the most common dermatologic findings, and no association was seen between cutaneous signs and type of ILD.
IN PRACTICE:
“Establishing an accurate timeline between MDA5 antibody-positive DM and ILD can promote urgency among dermatologists to evaluate extracutaneous manifestations in their management of patients with DM for more accurate risk stratification and appropriate treatment,” the authors wrote.
SOURCE:
This study, led by Rachel R. Lin, from the University of Miami, Miami, Florida, was published online as a research letter in JAMA Dermatology.
LIMITATIONS:
Study limitations were the study’s retrospective design and small sample size.
DISCLOSURES:
No information on study funding was provided. One author reported personal fees from argenX outside this submitted work. Other authors did not disclose any competing interests.
A version of this article appeared on Medscape.com.
TOPLINE:
The time interval between onset of interstitial lung disease (ILD) and diagnosis of anti–melanoma differentiation-associated gene 5 (MDA5) antibody-positive dermatomyositis (DM) “has not been well described,” the authors say.
METHODOLOGY:
- , with the former having a particularly high mortality rate.
- In this retrospective cohort study using electronic medical records, researchers evaluated 774 patients with DM between 2008 and 2023 to learn more about the time interval between ILD and the time of an MDA5 antibody-positive DM diagnosis, which has not been well described.
- The primary outcome was ILD diagnosis and time in days between documented ILD and MDA5 antibody-positive DM diagnoses.
TAKEAWAY:
- Overall, 14 patients with DM (1.8%) were diagnosed with MDA5 antibody-positive DM in dermatology, rheumatology, or pulmonology departments (nine women and five men; age, 24-77 years; 79% were White and 7% were Black).
- ILD was diagnosed in 9 of the 14 patients (64%); 6 of the 14 (43%) met the criteria for RPILD. Two cases were diagnosed concurrently and two prior to MDA5 antibody-positive DM diagnosis.
- The median time between ILD and MDA5 antibody-positive DM diagnoses was 163 days.
- Gottron papules/sign and midfacial erythema were the most common dermatologic findings, and no association was seen between cutaneous signs and type of ILD.
IN PRACTICE:
“Establishing an accurate timeline between MDA5 antibody-positive DM and ILD can promote urgency among dermatologists to evaluate extracutaneous manifestations in their management of patients with DM for more accurate risk stratification and appropriate treatment,” the authors wrote.
SOURCE:
This study, led by Rachel R. Lin, from the University of Miami, Miami, Florida, was published online as a research letter in JAMA Dermatology.
LIMITATIONS:
Study limitations were the study’s retrospective design and small sample size.
DISCLOSURES:
No information on study funding was provided. One author reported personal fees from argenX outside this submitted work. Other authors did not disclose any competing interests.
A version of this article appeared on Medscape.com.
TOPLINE:
The time interval between onset of interstitial lung disease (ILD) and diagnosis of anti–melanoma differentiation-associated gene 5 (MDA5) antibody-positive dermatomyositis (DM) “has not been well described,” the authors say.
METHODOLOGY:
- , with the former having a particularly high mortality rate.
- In this retrospective cohort study using electronic medical records, researchers evaluated 774 patients with DM between 2008 and 2023 to learn more about the time interval between ILD and the time of an MDA5 antibody-positive DM diagnosis, which has not been well described.
- The primary outcome was ILD diagnosis and time in days between documented ILD and MDA5 antibody-positive DM diagnoses.
TAKEAWAY:
- Overall, 14 patients with DM (1.8%) were diagnosed with MDA5 antibody-positive DM in dermatology, rheumatology, or pulmonology departments (nine women and five men; age, 24-77 years; 79% were White and 7% were Black).
- ILD was diagnosed in 9 of the 14 patients (64%); 6 of the 14 (43%) met the criteria for RPILD. Two cases were diagnosed concurrently and two prior to MDA5 antibody-positive DM diagnosis.
- The median time between ILD and MDA5 antibody-positive DM diagnoses was 163 days.
- Gottron papules/sign and midfacial erythema were the most common dermatologic findings, and no association was seen between cutaneous signs and type of ILD.
IN PRACTICE:
“Establishing an accurate timeline between MDA5 antibody-positive DM and ILD can promote urgency among dermatologists to evaluate extracutaneous manifestations in their management of patients with DM for more accurate risk stratification and appropriate treatment,” the authors wrote.
SOURCE:
This study, led by Rachel R. Lin, from the University of Miami, Miami, Florida, was published online as a research letter in JAMA Dermatology.
LIMITATIONS:
Study limitations were the study’s retrospective design and small sample size.
DISCLOSURES:
No information on study funding was provided. One author reported personal fees from argenX outside this submitted work. Other authors did not disclose any competing interests.
A version of this article appeared on Medscape.com.
Combined Pediatric Derm-Rheum Clinics Supported by Survey Respondents
TOPLINE:
.
METHODOLOGY:
- Combined pediatric dermatology-rheumatology clinics can improve patient outcomes and experiences, particularly for pediatric autoimmune conditions presenting with both cutaneous and systemic manifestations.
- The researchers surveyed 208 pediatric dermatologists working in combined pediatric dermatology-rheumatology clinics.
- A total of 13 member responses were recorded from three countries: 10 from the United States, two from Mexico, and one from Canada.
TAKEAWAY:
- Perceived benefits of combined clinics were improved patient care through coordinated treatment decisions and timely communication between providers.
- Patient satisfaction was favorable, and patients and families endorsed the combined clinic approach.
- Barriers to clinic establishment included differences in the pace between dermatology and rheumatology clinic flow, the need to generate more relative value units, resistance from colleagues, and limited time.
- Areas that needed improvement included more time for patient visits, dedicated research assistants, new patient referrals, additional patient rooms, resources for research, and patient care infrastructure.
IN PRACTICE:
The insights from this survey “will hopefully inspire further development of these combined clinics,” the authors wrote.
SOURCE:
The investigation, led by Olga S. Cherepakhin, BS, University of Washington, Seattle, Washington, was published in Pediatric Dermatology.
LIMITATIONS:
Limitations included the subjective nature, lack of some information, selection bias, and small number of respondents, and the survey reflected the perspective of the pediatric dermatologists only.
DISCLOSURES:
The study was supported by the National Center for Advancing Translational Sciences of the National Institutes of Health. One author reported full-time employment at Janssen R&D, and the other authors had no disclosures.
A version of this article appeared on Medscape.com.
TOPLINE:
.
METHODOLOGY:
- Combined pediatric dermatology-rheumatology clinics can improve patient outcomes and experiences, particularly for pediatric autoimmune conditions presenting with both cutaneous and systemic manifestations.
- The researchers surveyed 208 pediatric dermatologists working in combined pediatric dermatology-rheumatology clinics.
- A total of 13 member responses were recorded from three countries: 10 from the United States, two from Mexico, and one from Canada.
TAKEAWAY:
- Perceived benefits of combined clinics were improved patient care through coordinated treatment decisions and timely communication between providers.
- Patient satisfaction was favorable, and patients and families endorsed the combined clinic approach.
- Barriers to clinic establishment included differences in the pace between dermatology and rheumatology clinic flow, the need to generate more relative value units, resistance from colleagues, and limited time.
- Areas that needed improvement included more time for patient visits, dedicated research assistants, new patient referrals, additional patient rooms, resources for research, and patient care infrastructure.
IN PRACTICE:
The insights from this survey “will hopefully inspire further development of these combined clinics,” the authors wrote.
SOURCE:
The investigation, led by Olga S. Cherepakhin, BS, University of Washington, Seattle, Washington, was published in Pediatric Dermatology.
LIMITATIONS:
Limitations included the subjective nature, lack of some information, selection bias, and small number of respondents, and the survey reflected the perspective of the pediatric dermatologists only.
DISCLOSURES:
The study was supported by the National Center for Advancing Translational Sciences of the National Institutes of Health. One author reported full-time employment at Janssen R&D, and the other authors had no disclosures.
A version of this article appeared on Medscape.com.
TOPLINE:
.
METHODOLOGY:
- Combined pediatric dermatology-rheumatology clinics can improve patient outcomes and experiences, particularly for pediatric autoimmune conditions presenting with both cutaneous and systemic manifestations.
- The researchers surveyed 208 pediatric dermatologists working in combined pediatric dermatology-rheumatology clinics.
- A total of 13 member responses were recorded from three countries: 10 from the United States, two from Mexico, and one from Canada.
TAKEAWAY:
- Perceived benefits of combined clinics were improved patient care through coordinated treatment decisions and timely communication between providers.
- Patient satisfaction was favorable, and patients and families endorsed the combined clinic approach.
- Barriers to clinic establishment included differences in the pace between dermatology and rheumatology clinic flow, the need to generate more relative value units, resistance from colleagues, and limited time.
- Areas that needed improvement included more time for patient visits, dedicated research assistants, new patient referrals, additional patient rooms, resources for research, and patient care infrastructure.
IN PRACTICE:
The insights from this survey “will hopefully inspire further development of these combined clinics,” the authors wrote.
SOURCE:
The investigation, led by Olga S. Cherepakhin, BS, University of Washington, Seattle, Washington, was published in Pediatric Dermatology.
LIMITATIONS:
Limitations included the subjective nature, lack of some information, selection bias, and small number of respondents, and the survey reflected the perspective of the pediatric dermatologists only.
DISCLOSURES:
The study was supported by the National Center for Advancing Translational Sciences of the National Institutes of Health. One author reported full-time employment at Janssen R&D, and the other authors had no disclosures.
A version of this article appeared on Medscape.com.
Burnout
In last month’s column, I discussed employees who are “clock watchers” and how to address this issue in your practice if it exists. Here’s another scenario you may encounter from the Office Politics Forum at the recent American Academy of Dermatology annual meeting:
A 40-year-old dermatologist has practiced in the same office since residency and is loved by patients and staff. He remained with the practice through its takeover by a local hospital three years previously. Recently, over a 3-month period, everyone in the office notices a change in this dermatologist’s behavior. He no longer appears happy, is argumentative with staff and patients alike, often dismisses patients’ concerns, and calls in sick during the practice’s busiest days.
. According to the American Medical Association’s National Burnout Benchmarking report, over 50% of physicians report some characteristics of burnout, which include emotional exhaustion, depersonalization, and a feeling of decreased personal achievement.
The causes of physician burnout are multifactorial and vary in importance, depending on the individual and on which authorities you consult. Here are some of the most prevalent, based on my experience and research:
Bureaucratic and Administrative Tasks: The burden of paperwork and other administrative responsibilities has increased, consuming time that could be spent on patient care or personal well-being.
Electronic Health Record (EHR) Stress: As I (and many others) have predicted for decades, the demands of EHR documentation and the associated clerical tasks have become a major source of what is now called “technostress,” detracting from the efficiency and effectiveness of healthcare delivery.
Insurance and Regulatory Demands: Navigating insurance appeals and prior authorizations, meeting regulatory requirements, and dealing with the complexities of healthcare reimbursement systems add to the stress and frustration experienced by physicians.
Lack of Autonomy and Control: As small practices consolidate, physicians often face constraints on their professional autonomy, with limited control over their work environment, schedules, and clinical decision-making, leading to feelings of helplessness and dissatisfaction.
Emotional Exhaustion from Patient Care: The emotional toll of caring for patients, especially in high-stakes or emotionally charged specialties, can lead to compassion fatigue and burnout. This may account for the results of a 2023 Medscape report in which physicians reporting the most burnout worked in emergency medicine, internal medicine, pediatrics, obstetrics/gynecology, and infectious diseases.
Work-Life Imbalance: The demanding nature of the profession often leads to difficulties in balancing professional responsibilities with personal life, contributing to burnout.
Inadequate Support and Recognition: A lack of support from healthcare institutions and insufficient recognition of the challenges faced by physicians can exacerbate feelings of isolation and undervaluation.
Addressing physician burnout requires a systems-based approach that targets these root causes at all levels, from individual coping strategies to organizational and systemic changes in the healthcare industry. Here are some strategies that have worked for me and others:
Optimize Practice Efficiency: This is the consistent theme of this column over several decades: Streamline office processes to enhance the quality of care while reducing unnecessary workload. This can involve adopting efficient patient scheduling systems, improving clinic flow, and utilizing technology like patient portals judiciously to avoid increasing the task load without compensation.
Promote Work-Life Balance: Encourage a culture that values work-life balance. This can include flexible scheduling, respecting off-duty hours by limiting non-emergency work communications, and using your vacation time. Remember Eastern’s First Law: Your last words will NOT be, “I wish I had spent more time in the office.”
Implement Medical Scribes: I’ve written frequently about this, including a recent column on the new artificial intelligence (AI) scribes, such as DeepCura, DeepScribe, Nuance, Suki, Augmedix, Tali AI, Iodine Software, ScribeLink, and Amazon Web Services’ new HealthScribe product. Utilizing medical scribes to handle documentation can significantly reduce the administrative burden, allowing physicians to focus more on patient care rather than paperwork, potentially improving both physician and patient satisfaction. (As always, I have no financial interest in any product or service mentioned in this column.)
Provide Professional Development Opportunities: Offer opportunities for professional growth and development. This can include attending conferences, participating in research, or providing time and resources for continuing education. Such opportunities can reinvigorate a physician’s passion for medicine and improve job satisfaction.
Foster a Supportive Work Environment: Create a supportive work culture where staff and physicians feel comfortable discussing challenges and seeking support. Regular meetings or check-ins can help identify early signs of burnout and address them proactively.
Evaluate and Adjust Workloads: Regularly assess physician workloads to ensure they are manageable. Adjusting patient loads, redistributing tasks among team members, or hiring additional staff can help prevent burnout.
Leadership Training and Support: Provide training for leaders within the practice on recognizing signs of burnout and effective management strategies. Supportive leadership is crucial in creating an environment where physicians feel valued and heard.
Peer Support and Mentorship Programs: Establish peer support or mentorship programs where physicians can share experiences, offer advice, and provide emotional support to each other.
Feedback and Continuous Improvement: Managers should regularly solicit feedback from physicians regarding their workload, job satisfaction, and suggestions for improvements. Actively work on implementing feasible changes to address concerns.
Dr. Eastern practices dermatology and dermatologic surgery in Belleville, N.J. He is the author of numerous articles and textbook chapters, and is a longtime monthly columnist for Dermatology News. Write to him at [email protected].
In last month’s column, I discussed employees who are “clock watchers” and how to address this issue in your practice if it exists. Here’s another scenario you may encounter from the Office Politics Forum at the recent American Academy of Dermatology annual meeting:
A 40-year-old dermatologist has practiced in the same office since residency and is loved by patients and staff. He remained with the practice through its takeover by a local hospital three years previously. Recently, over a 3-month period, everyone in the office notices a change in this dermatologist’s behavior. He no longer appears happy, is argumentative with staff and patients alike, often dismisses patients’ concerns, and calls in sick during the practice’s busiest days.
. According to the American Medical Association’s National Burnout Benchmarking report, over 50% of physicians report some characteristics of burnout, which include emotional exhaustion, depersonalization, and a feeling of decreased personal achievement.
The causes of physician burnout are multifactorial and vary in importance, depending on the individual and on which authorities you consult. Here are some of the most prevalent, based on my experience and research:
Bureaucratic and Administrative Tasks: The burden of paperwork and other administrative responsibilities has increased, consuming time that could be spent on patient care or personal well-being.
Electronic Health Record (EHR) Stress: As I (and many others) have predicted for decades, the demands of EHR documentation and the associated clerical tasks have become a major source of what is now called “technostress,” detracting from the efficiency and effectiveness of healthcare delivery.
Insurance and Regulatory Demands: Navigating insurance appeals and prior authorizations, meeting regulatory requirements, and dealing with the complexities of healthcare reimbursement systems add to the stress and frustration experienced by physicians.
Lack of Autonomy and Control: As small practices consolidate, physicians often face constraints on their professional autonomy, with limited control over their work environment, schedules, and clinical decision-making, leading to feelings of helplessness and dissatisfaction.
Emotional Exhaustion from Patient Care: The emotional toll of caring for patients, especially in high-stakes or emotionally charged specialties, can lead to compassion fatigue and burnout. This may account for the results of a 2023 Medscape report in which physicians reporting the most burnout worked in emergency medicine, internal medicine, pediatrics, obstetrics/gynecology, and infectious diseases.
Work-Life Imbalance: The demanding nature of the profession often leads to difficulties in balancing professional responsibilities with personal life, contributing to burnout.
Inadequate Support and Recognition: A lack of support from healthcare institutions and insufficient recognition of the challenges faced by physicians can exacerbate feelings of isolation and undervaluation.
Addressing physician burnout requires a systems-based approach that targets these root causes at all levels, from individual coping strategies to organizational and systemic changes in the healthcare industry. Here are some strategies that have worked for me and others:
Optimize Practice Efficiency: This is the consistent theme of this column over several decades: Streamline office processes to enhance the quality of care while reducing unnecessary workload. This can involve adopting efficient patient scheduling systems, improving clinic flow, and utilizing technology like patient portals judiciously to avoid increasing the task load without compensation.
Promote Work-Life Balance: Encourage a culture that values work-life balance. This can include flexible scheduling, respecting off-duty hours by limiting non-emergency work communications, and using your vacation time. Remember Eastern’s First Law: Your last words will NOT be, “I wish I had spent more time in the office.”
Implement Medical Scribes: I’ve written frequently about this, including a recent column on the new artificial intelligence (AI) scribes, such as DeepCura, DeepScribe, Nuance, Suki, Augmedix, Tali AI, Iodine Software, ScribeLink, and Amazon Web Services’ new HealthScribe product. Utilizing medical scribes to handle documentation can significantly reduce the administrative burden, allowing physicians to focus more on patient care rather than paperwork, potentially improving both physician and patient satisfaction. (As always, I have no financial interest in any product or service mentioned in this column.)
Provide Professional Development Opportunities: Offer opportunities for professional growth and development. This can include attending conferences, participating in research, or providing time and resources for continuing education. Such opportunities can reinvigorate a physician’s passion for medicine and improve job satisfaction.
Foster a Supportive Work Environment: Create a supportive work culture where staff and physicians feel comfortable discussing challenges and seeking support. Regular meetings or check-ins can help identify early signs of burnout and address them proactively.
Evaluate and Adjust Workloads: Regularly assess physician workloads to ensure they are manageable. Adjusting patient loads, redistributing tasks among team members, or hiring additional staff can help prevent burnout.
Leadership Training and Support: Provide training for leaders within the practice on recognizing signs of burnout and effective management strategies. Supportive leadership is crucial in creating an environment where physicians feel valued and heard.
Peer Support and Mentorship Programs: Establish peer support or mentorship programs where physicians can share experiences, offer advice, and provide emotional support to each other.
Feedback and Continuous Improvement: Managers should regularly solicit feedback from physicians regarding their workload, job satisfaction, and suggestions for improvements. Actively work on implementing feasible changes to address concerns.
Dr. Eastern practices dermatology and dermatologic surgery in Belleville, N.J. He is the author of numerous articles and textbook chapters, and is a longtime monthly columnist for Dermatology News. Write to him at [email protected].
In last month’s column, I discussed employees who are “clock watchers” and how to address this issue in your practice if it exists. Here’s another scenario you may encounter from the Office Politics Forum at the recent American Academy of Dermatology annual meeting:
A 40-year-old dermatologist has practiced in the same office since residency and is loved by patients and staff. He remained with the practice through its takeover by a local hospital three years previously. Recently, over a 3-month period, everyone in the office notices a change in this dermatologist’s behavior. He no longer appears happy, is argumentative with staff and patients alike, often dismisses patients’ concerns, and calls in sick during the practice’s busiest days.
. According to the American Medical Association’s National Burnout Benchmarking report, over 50% of physicians report some characteristics of burnout, which include emotional exhaustion, depersonalization, and a feeling of decreased personal achievement.
The causes of physician burnout are multifactorial and vary in importance, depending on the individual and on which authorities you consult. Here are some of the most prevalent, based on my experience and research:
Bureaucratic and Administrative Tasks: The burden of paperwork and other administrative responsibilities has increased, consuming time that could be spent on patient care or personal well-being.
Electronic Health Record (EHR) Stress: As I (and many others) have predicted for decades, the demands of EHR documentation and the associated clerical tasks have become a major source of what is now called “technostress,” detracting from the efficiency and effectiveness of healthcare delivery.
Insurance and Regulatory Demands: Navigating insurance appeals and prior authorizations, meeting regulatory requirements, and dealing with the complexities of healthcare reimbursement systems add to the stress and frustration experienced by physicians.
Lack of Autonomy and Control: As small practices consolidate, physicians often face constraints on their professional autonomy, with limited control over their work environment, schedules, and clinical decision-making, leading to feelings of helplessness and dissatisfaction.
Emotional Exhaustion from Patient Care: The emotional toll of caring for patients, especially in high-stakes or emotionally charged specialties, can lead to compassion fatigue and burnout. This may account for the results of a 2023 Medscape report in which physicians reporting the most burnout worked in emergency medicine, internal medicine, pediatrics, obstetrics/gynecology, and infectious diseases.
Work-Life Imbalance: The demanding nature of the profession often leads to difficulties in balancing professional responsibilities with personal life, contributing to burnout.
Inadequate Support and Recognition: A lack of support from healthcare institutions and insufficient recognition of the challenges faced by physicians can exacerbate feelings of isolation and undervaluation.
Addressing physician burnout requires a systems-based approach that targets these root causes at all levels, from individual coping strategies to organizational and systemic changes in the healthcare industry. Here are some strategies that have worked for me and others:
Optimize Practice Efficiency: This is the consistent theme of this column over several decades: Streamline office processes to enhance the quality of care while reducing unnecessary workload. This can involve adopting efficient patient scheduling systems, improving clinic flow, and utilizing technology like patient portals judiciously to avoid increasing the task load without compensation.
Promote Work-Life Balance: Encourage a culture that values work-life balance. This can include flexible scheduling, respecting off-duty hours by limiting non-emergency work communications, and using your vacation time. Remember Eastern’s First Law: Your last words will NOT be, “I wish I had spent more time in the office.”
Implement Medical Scribes: I’ve written frequently about this, including a recent column on the new artificial intelligence (AI) scribes, such as DeepCura, DeepScribe, Nuance, Suki, Augmedix, Tali AI, Iodine Software, ScribeLink, and Amazon Web Services’ new HealthScribe product. Utilizing medical scribes to handle documentation can significantly reduce the administrative burden, allowing physicians to focus more on patient care rather than paperwork, potentially improving both physician and patient satisfaction. (As always, I have no financial interest in any product or service mentioned in this column.)
Provide Professional Development Opportunities: Offer opportunities for professional growth and development. This can include attending conferences, participating in research, or providing time and resources for continuing education. Such opportunities can reinvigorate a physician’s passion for medicine and improve job satisfaction.
Foster a Supportive Work Environment: Create a supportive work culture where staff and physicians feel comfortable discussing challenges and seeking support. Regular meetings or check-ins can help identify early signs of burnout and address them proactively.
Evaluate and Adjust Workloads: Regularly assess physician workloads to ensure they are manageable. Adjusting patient loads, redistributing tasks among team members, or hiring additional staff can help prevent burnout.
Leadership Training and Support: Provide training for leaders within the practice on recognizing signs of burnout and effective management strategies. Supportive leadership is crucial in creating an environment where physicians feel valued and heard.
Peer Support and Mentorship Programs: Establish peer support or mentorship programs where physicians can share experiences, offer advice, and provide emotional support to each other.
Feedback and Continuous Improvement: Managers should regularly solicit feedback from physicians regarding their workload, job satisfaction, and suggestions for improvements. Actively work on implementing feasible changes to address concerns.
Dr. Eastern practices dermatology and dermatologic surgery in Belleville, N.J. He is the author of numerous articles and textbook chapters, and is a longtime monthly columnist for Dermatology News. Write to him at [email protected].
Mining EHRs with AI to Predict RA Outcomes: Coming to You Soon?
Rheumatologists and their staff have been dutifully recording disease activity and patient-reported outcomes for decades, and now, all that drudgery is beginning to pay off with the introduction of artificial intelligence (AI) and natural language processing systems that can mine electronic health records (EHRs) for nuggets of research gold and accurately predict short-term rheumatoid arthritis (RA) outcomes.
“I think we have learned from our very early experiments that longitudinal deep learning models can forecast rheumatoid arthritis [RA] outcomes with actually surprising efficiency, with fewer patients than we assumed would be needed,” said Jinoos Yazdany, MD, MPH, chief of rheumatology at Zuckerberg San Francisco General Hospital and Trauma Center, and codirector of the University of California San Francisco (UCSF) Quality and Informatics Lab.
At the 2024 Rheumatoid Arthritis Research Summit (RA Summit 2024), presented by the Arthritis Foundation and the Hospital for Special Surgery in New York City, Dr. Yazdany discussed why rheumatologists are well positioned to take advantage of predictive analytics and how natural language processing systems can be used to extract previously hard-to-find data from EHRs, which can then be applied to RA prognostics and research.
Data Galore
EHR data can be particularly useful for RA research because of the large volume of information, clinical data such as notes and imaging, less selection bias compared with other data sources such as cohorts or randomized controlled trials, real-time access, and the fact that many records contain longitudinal data (follow-ups, etc.).
However, EHR data may have gaps or inaccurate coding, and data such as text and images may require significant data processing and scrubbing before it can be used to advance research. In addition, EHR data are subject to patient privacy and security concerns, can be plagued by incompatibility across different systems, and may not represent patients who have less access to care, Dr. Yazdany said.
She noted that most rheumatologists record some measure of RA disease activity and patient physical function, and that patient-reported outcomes have been routinely incorporated into clinical records, especially since the 1980 introduction of the Health Assessment Questionnaire.
“In rheumatology, by achieving consensus and building a national quality measurement program, we have a cohesive national RA outcome measure selection strategy. RA outcomes are available for a majority of patients seen by rheumatologists, and that’s a critical strength of EHR data,” she said.
Spinning Text Into Analytics
The challenge for investigators who want to use this treasure trove of RA data is that more than 80% of the data are in the form of text, which raises questions about how to best extract outcomes data and drug dosing information from the written record.
As described in an article published online in Arthritis Care & Research February 14, 2023, Dr. Yazdany and colleagues at UCSF and Stanford University developed a natural language processing “pipeline” designed to extract RA outcomes from clinical notes on all patients included in the American College of Rheumatology’s Rheumatology Informatics System for Effectiveness (RISE) registry.
The model used expert-curated terms and a text processing tool to identify patterns and numerical scores linked to outcome measures in the records.
“This was an enormously difficult and ambitious project because we had many, many sites, the data was very messy, we had very complicated [independent review board] procedures, and we actually had to go through de-identification procedures because we were using this data for research, so we learned a lot,” Dr. Yazdany said.
The model processed 34 million notes on 854,628 patients across 158 practices and 24 different EHR systems.
In internal validation studies, the models had 95% sensitivity, 87% positive predictive value (PPV), and an F1 score (a measure of predictive performance) of 91%. Applying the model to an EHR from a large, non-RISE health system for external validation, the natural language processing pipeline had a 92% sensitivity, 69% PPV, and an F1 score of 79%.
The investigators also looked at the use of OpenAI large language models, including GPT 3.5 and 4 to interpret complex prescription orders and found that after training with 100 examples, GPT 4 was able to correctly interpret 95.6% of orders. But this experiment came at a high computational and financial cost, with one experiment running north of $3000, Dr. Yazdany cautioned.
Predicting Outcomes
Experiments to see whether an AI system can forecast RA disease activity at the next clinic visit are in their early stages.
Dr. Yazdany and colleagues used EHR data from UCSF and Zuckerberg San Francisco General Hospital on patients with two RA diagnostic codes at 30 days apart, who had at least one disease-modifying antirheumatic drug prescription and two Clinical Disease Activity Index (CDAI) scores 30 days apart.
One model, designed to predict CDAI at the next visit by “playing the odds” based on clinical experience, showed that about 60% of patients at UCSF achieved treat-to-target goals, while the remaining 40% did not.
This model performed barely better than pure chance, with an area under the receiver operating characteristic curve (AUC) of 0.54.
A second model that included the patient’s last CDAI score also fared little better than a roll of the dice, with an AUC of 0.55.
However, a neural network or “deep learning” model designed to process data akin to the way that the human brain works performed much better at predicting outcomes at the second visit, with an AUC of 0.91.
Applying the UCSF-trained neural network model to the Zuckerberg San Francisco General Hospital population, with different patient characteristics from those of UCSF, the AUC was 0.74. Although this result was not as good as that seen when applied to UCSF patients, it demonstrated that the model retains some predictive capability across different hospital systems, Dr. Yazdany said.
The next steps, she said, are to build more robust models based on vast and varied patient data pools that will allow the predictive models to be generalized across various healthcare settings.
The Here and Now
In the Q & A following the presentation, an audience member said that the study was “very cool stuff.”
“Is there a way to sort of get ahead and think of the technology that we’re starting to pilot? Hospitals are already using AI scribes, for example, to collect the data that is going to make it much easier to feed it to the predictive analytics that we’re going to use,” she said.
Dr. Yazdany replied that “over the last couple of years, one of the projects that we’ve worked on is to interview rheumatologists who are participating in the RISE registry about the ways that they are collecting [patient-reported outcomes], and it has been fascinating: A vast majority of people are still using paper forms.”
“The challenge is that our patient populations are very diverse. Technology, and especially filling out forms via online platforms, doesn’t work for everybody, and in some ways, filling out the paper forms when you go to the doctor’s office is a great equalizer. So, I think that we have some real challenges, and the solutions have to be embedded in the real world,” she added.
Dr. Yazdany’s research was supported by grants from the Agency for Healthcare Research & Quality and the National Institutes of Health. She disclosed consulting fees and/or research support from AstraZeneca, Aurinia, Bristol Myers Squibb, Gilead, and Pfizer.
A version of this article appeared on Medscape.com.
Rheumatologists and their staff have been dutifully recording disease activity and patient-reported outcomes for decades, and now, all that drudgery is beginning to pay off with the introduction of artificial intelligence (AI) and natural language processing systems that can mine electronic health records (EHRs) for nuggets of research gold and accurately predict short-term rheumatoid arthritis (RA) outcomes.
“I think we have learned from our very early experiments that longitudinal deep learning models can forecast rheumatoid arthritis [RA] outcomes with actually surprising efficiency, with fewer patients than we assumed would be needed,” said Jinoos Yazdany, MD, MPH, chief of rheumatology at Zuckerberg San Francisco General Hospital and Trauma Center, and codirector of the University of California San Francisco (UCSF) Quality and Informatics Lab.
At the 2024 Rheumatoid Arthritis Research Summit (RA Summit 2024), presented by the Arthritis Foundation and the Hospital for Special Surgery in New York City, Dr. Yazdany discussed why rheumatologists are well positioned to take advantage of predictive analytics and how natural language processing systems can be used to extract previously hard-to-find data from EHRs, which can then be applied to RA prognostics and research.
Data Galore
EHR data can be particularly useful for RA research because of the large volume of information, clinical data such as notes and imaging, less selection bias compared with other data sources such as cohorts or randomized controlled trials, real-time access, and the fact that many records contain longitudinal data (follow-ups, etc.).
However, EHR data may have gaps or inaccurate coding, and data such as text and images may require significant data processing and scrubbing before it can be used to advance research. In addition, EHR data are subject to patient privacy and security concerns, can be plagued by incompatibility across different systems, and may not represent patients who have less access to care, Dr. Yazdany said.
She noted that most rheumatologists record some measure of RA disease activity and patient physical function, and that patient-reported outcomes have been routinely incorporated into clinical records, especially since the 1980 introduction of the Health Assessment Questionnaire.
“In rheumatology, by achieving consensus and building a national quality measurement program, we have a cohesive national RA outcome measure selection strategy. RA outcomes are available for a majority of patients seen by rheumatologists, and that’s a critical strength of EHR data,” she said.
Spinning Text Into Analytics
The challenge for investigators who want to use this treasure trove of RA data is that more than 80% of the data are in the form of text, which raises questions about how to best extract outcomes data and drug dosing information from the written record.
As described in an article published online in Arthritis Care & Research February 14, 2023, Dr. Yazdany and colleagues at UCSF and Stanford University developed a natural language processing “pipeline” designed to extract RA outcomes from clinical notes on all patients included in the American College of Rheumatology’s Rheumatology Informatics System for Effectiveness (RISE) registry.
The model used expert-curated terms and a text processing tool to identify patterns and numerical scores linked to outcome measures in the records.
“This was an enormously difficult and ambitious project because we had many, many sites, the data was very messy, we had very complicated [independent review board] procedures, and we actually had to go through de-identification procedures because we were using this data for research, so we learned a lot,” Dr. Yazdany said.
The model processed 34 million notes on 854,628 patients across 158 practices and 24 different EHR systems.
In internal validation studies, the models had 95% sensitivity, 87% positive predictive value (PPV), and an F1 score (a measure of predictive performance) of 91%. Applying the model to an EHR from a large, non-RISE health system for external validation, the natural language processing pipeline had a 92% sensitivity, 69% PPV, and an F1 score of 79%.
The investigators also looked at the use of OpenAI large language models, including GPT 3.5 and 4 to interpret complex prescription orders and found that after training with 100 examples, GPT 4 was able to correctly interpret 95.6% of orders. But this experiment came at a high computational and financial cost, with one experiment running north of $3000, Dr. Yazdany cautioned.
Predicting Outcomes
Experiments to see whether an AI system can forecast RA disease activity at the next clinic visit are in their early stages.
Dr. Yazdany and colleagues used EHR data from UCSF and Zuckerberg San Francisco General Hospital on patients with two RA diagnostic codes at 30 days apart, who had at least one disease-modifying antirheumatic drug prescription and two Clinical Disease Activity Index (CDAI) scores 30 days apart.
One model, designed to predict CDAI at the next visit by “playing the odds” based on clinical experience, showed that about 60% of patients at UCSF achieved treat-to-target goals, while the remaining 40% did not.
This model performed barely better than pure chance, with an area under the receiver operating characteristic curve (AUC) of 0.54.
A second model that included the patient’s last CDAI score also fared little better than a roll of the dice, with an AUC of 0.55.
However, a neural network or “deep learning” model designed to process data akin to the way that the human brain works performed much better at predicting outcomes at the second visit, with an AUC of 0.91.
Applying the UCSF-trained neural network model to the Zuckerberg San Francisco General Hospital population, with different patient characteristics from those of UCSF, the AUC was 0.74. Although this result was not as good as that seen when applied to UCSF patients, it demonstrated that the model retains some predictive capability across different hospital systems, Dr. Yazdany said.
The next steps, she said, are to build more robust models based on vast and varied patient data pools that will allow the predictive models to be generalized across various healthcare settings.
The Here and Now
In the Q & A following the presentation, an audience member said that the study was “very cool stuff.”
“Is there a way to sort of get ahead and think of the technology that we’re starting to pilot? Hospitals are already using AI scribes, for example, to collect the data that is going to make it much easier to feed it to the predictive analytics that we’re going to use,” she said.
Dr. Yazdany replied that “over the last couple of years, one of the projects that we’ve worked on is to interview rheumatologists who are participating in the RISE registry about the ways that they are collecting [patient-reported outcomes], and it has been fascinating: A vast majority of people are still using paper forms.”
“The challenge is that our patient populations are very diverse. Technology, and especially filling out forms via online platforms, doesn’t work for everybody, and in some ways, filling out the paper forms when you go to the doctor’s office is a great equalizer. So, I think that we have some real challenges, and the solutions have to be embedded in the real world,” she added.
Dr. Yazdany’s research was supported by grants from the Agency for Healthcare Research & Quality and the National Institutes of Health. She disclosed consulting fees and/or research support from AstraZeneca, Aurinia, Bristol Myers Squibb, Gilead, and Pfizer.
A version of this article appeared on Medscape.com.
Rheumatologists and their staff have been dutifully recording disease activity and patient-reported outcomes for decades, and now, all that drudgery is beginning to pay off with the introduction of artificial intelligence (AI) and natural language processing systems that can mine electronic health records (EHRs) for nuggets of research gold and accurately predict short-term rheumatoid arthritis (RA) outcomes.
“I think we have learned from our very early experiments that longitudinal deep learning models can forecast rheumatoid arthritis [RA] outcomes with actually surprising efficiency, with fewer patients than we assumed would be needed,” said Jinoos Yazdany, MD, MPH, chief of rheumatology at Zuckerberg San Francisco General Hospital and Trauma Center, and codirector of the University of California San Francisco (UCSF) Quality and Informatics Lab.
At the 2024 Rheumatoid Arthritis Research Summit (RA Summit 2024), presented by the Arthritis Foundation and the Hospital for Special Surgery in New York City, Dr. Yazdany discussed why rheumatologists are well positioned to take advantage of predictive analytics and how natural language processing systems can be used to extract previously hard-to-find data from EHRs, which can then be applied to RA prognostics and research.
Data Galore
EHR data can be particularly useful for RA research because of the large volume of information, clinical data such as notes and imaging, less selection bias compared with other data sources such as cohorts or randomized controlled trials, real-time access, and the fact that many records contain longitudinal data (follow-ups, etc.).
However, EHR data may have gaps or inaccurate coding, and data such as text and images may require significant data processing and scrubbing before it can be used to advance research. In addition, EHR data are subject to patient privacy and security concerns, can be plagued by incompatibility across different systems, and may not represent patients who have less access to care, Dr. Yazdany said.
She noted that most rheumatologists record some measure of RA disease activity and patient physical function, and that patient-reported outcomes have been routinely incorporated into clinical records, especially since the 1980 introduction of the Health Assessment Questionnaire.
“In rheumatology, by achieving consensus and building a national quality measurement program, we have a cohesive national RA outcome measure selection strategy. RA outcomes are available for a majority of patients seen by rheumatologists, and that’s a critical strength of EHR data,” she said.
Spinning Text Into Analytics
The challenge for investigators who want to use this treasure trove of RA data is that more than 80% of the data are in the form of text, which raises questions about how to best extract outcomes data and drug dosing information from the written record.
As described in an article published online in Arthritis Care & Research February 14, 2023, Dr. Yazdany and colleagues at UCSF and Stanford University developed a natural language processing “pipeline” designed to extract RA outcomes from clinical notes on all patients included in the American College of Rheumatology’s Rheumatology Informatics System for Effectiveness (RISE) registry.
The model used expert-curated terms and a text processing tool to identify patterns and numerical scores linked to outcome measures in the records.
“This was an enormously difficult and ambitious project because we had many, many sites, the data was very messy, we had very complicated [independent review board] procedures, and we actually had to go through de-identification procedures because we were using this data for research, so we learned a lot,” Dr. Yazdany said.
The model processed 34 million notes on 854,628 patients across 158 practices and 24 different EHR systems.
In internal validation studies, the models had 95% sensitivity, 87% positive predictive value (PPV), and an F1 score (a measure of predictive performance) of 91%. Applying the model to an EHR from a large, non-RISE health system for external validation, the natural language processing pipeline had a 92% sensitivity, 69% PPV, and an F1 score of 79%.
The investigators also looked at the use of OpenAI large language models, including GPT 3.5 and 4 to interpret complex prescription orders and found that after training with 100 examples, GPT 4 was able to correctly interpret 95.6% of orders. But this experiment came at a high computational and financial cost, with one experiment running north of $3000, Dr. Yazdany cautioned.
Predicting Outcomes
Experiments to see whether an AI system can forecast RA disease activity at the next clinic visit are in their early stages.
Dr. Yazdany and colleagues used EHR data from UCSF and Zuckerberg San Francisco General Hospital on patients with two RA diagnostic codes at 30 days apart, who had at least one disease-modifying antirheumatic drug prescription and two Clinical Disease Activity Index (CDAI) scores 30 days apart.
One model, designed to predict CDAI at the next visit by “playing the odds” based on clinical experience, showed that about 60% of patients at UCSF achieved treat-to-target goals, while the remaining 40% did not.
This model performed barely better than pure chance, with an area under the receiver operating characteristic curve (AUC) of 0.54.
A second model that included the patient’s last CDAI score also fared little better than a roll of the dice, with an AUC of 0.55.
However, a neural network or “deep learning” model designed to process data akin to the way that the human brain works performed much better at predicting outcomes at the second visit, with an AUC of 0.91.
Applying the UCSF-trained neural network model to the Zuckerberg San Francisco General Hospital population, with different patient characteristics from those of UCSF, the AUC was 0.74. Although this result was not as good as that seen when applied to UCSF patients, it demonstrated that the model retains some predictive capability across different hospital systems, Dr. Yazdany said.
The next steps, she said, are to build more robust models based on vast and varied patient data pools that will allow the predictive models to be generalized across various healthcare settings.
The Here and Now
In the Q & A following the presentation, an audience member said that the study was “very cool stuff.”
“Is there a way to sort of get ahead and think of the technology that we’re starting to pilot? Hospitals are already using AI scribes, for example, to collect the data that is going to make it much easier to feed it to the predictive analytics that we’re going to use,” she said.
Dr. Yazdany replied that “over the last couple of years, one of the projects that we’ve worked on is to interview rheumatologists who are participating in the RISE registry about the ways that they are collecting [patient-reported outcomes], and it has been fascinating: A vast majority of people are still using paper forms.”
“The challenge is that our patient populations are very diverse. Technology, and especially filling out forms via online platforms, doesn’t work for everybody, and in some ways, filling out the paper forms when you go to the doctor’s office is a great equalizer. So, I think that we have some real challenges, and the solutions have to be embedded in the real world,” she added.
Dr. Yazdany’s research was supported by grants from the Agency for Healthcare Research & Quality and the National Institutes of Health. She disclosed consulting fees and/or research support from AstraZeneca, Aurinia, Bristol Myers Squibb, Gilead, and Pfizer.
A version of this article appeared on Medscape.com.
FROM RA SUMMIT 2024
Shared Rheumatology-Primary Care Telehealth Model Brings Services to Rural Areas
Even in large urban areas there aren’t enough rheumatologists to go around, and as a 2015 American College of Rheumatology workforce study projected, the number of rheumatology providers is expected to drop by 25% by the year 2030, while the demand for patient care in rheumatology is expected to increase by more than 100%.
The shortage of rheumatology care is even more acute in rural areas, but as a pilot project supported by the Arthritis Foundation shows, linking rheumatologists to health centers in remote and underserved locations via telehealth can help community providers improve care for patients with rheumatic diseases.
The novel collaborative model was described by Alfredo Rivadeneira, MD, professor of medicine in the division of rheumatology, allergy, and immunology at the University of North Carolina (UNC) School of Medicine in Chapel Hill, North Carolina.
“We found that this pilot, a unique partnership in North Carolina, improves access to rheumatology care to a rural population with high satisfaction scores. It underlines the importance of seeking collaboration with community providers when implementing these programs. It also allows timely specialty care and alleviates the barriers relating to transportation, insurance coverage, and telecommunication challenges,” he said at the 2024 Rheumatoid Arthritis Research Summit presented by the Arthritis Foundation and the Hospital for Special Surgery in New York City.
Too Many Patients, Too Few Rheumatologists
Access to health is challenging for people from traditionally underserved racial and ethnic backgrounds, especially in states such as North Carolina, where 40% of the population lives in rural counties, which have higher age-adjusted mortality than more densely populated areas of the state, Dr. Rivadeneira said.
In addition, 42% of the North Carolina residents seen at the state’s 42 Federally Qualified Health Centers (FQHCs) don’t have health insurance, which is higher than the average of 23% uninsured seen at FQHCs in other states.
There are currently approximately 250 rheumatology providers in North Carolina, the majority of whom work in the states’ three academic medical centers. Currently, North Carolina has an estimated population of 10 million people, which is projected to increase to 11.7 million by 2030. And by 2030, 20% of North Carolinians will be aged ≥ 65 years, Dr. Rivadeneira said, highlighting the need for expanded rheumatology care.
Although telehealth services could be an option for expanding services to underserved communities, only 14 of the 42 FQHCs in the state use telehealth and only on a limited basis because it is not sufficiently reimbursed.
Rivadeneira pointed to a 2022 study that showed how patients with rheumatic and musculoskeletal disease patients in North Carolina were less likely to use online patient portals if they lived in rural areas; came from racial or ethnic minority backgrounds; were older, men, had lower economic status (Medicaid enrollment or uninsured); or spoke a language other than English as their primary tongue.
Pilot Project
To help smooth out some of the above-mentioned disparities, Dr. Rivadeneira and colleagues, in collaboration with the Arthritis Foundation, started a pilot project in 2022 designed to enhance access to rheumatology specialty care for rural residents through a shared telehealth model between the UNC rheumatology clinic and two separate Piedmont Health Services clinics in rural areas.
The project includes tailored educational sessions designed to empower Piedmont Health Services providers for evaluating and managing patients with rheumatic diseases.
Patients with prior diagnoses of rheumatologic diseases who were lost to rheumatology specialty care follow-up and those with new rheumatic symptoms who had transportation and/or financial barriers to receiving specialty care are triaged to the shared telemedicine visits.
Providers conduct monthly clinic sessions via shared visits between the on-site Piedmont Health Services provider and patients, with off-site UNC rheumatology fellows and attending physicians connected virtually.
The educational component of the project includes monthly didactic sessions offered to all Piedmont Health Services providers across 12 locations.
The topics that were chosen cover the most common rheumatologic conditions seen by community providers, including evaluating pain from a rheumatology perspective; using antinuclear antibodies and other serologies; evaluating and managing rheumatoid arthritis, lupus, gout, giant cell arteritis, polymyalgia rheumatica, and osteoarthritis; and methotrexate management and complications.
“One of the aspects of this pilot that I want to emphasize is the importance of having the generalists with the patient, relaying the objective data, especially the physical exam, and that’s one of the great features of this model. It also provides a stable platform for telehealth to the individual patients, as many of these patients don’t have access to health technology,” Dr. Rivadeneira said.
Thumbs Up
Both patients and general practitioners in the Piedmont Health system expressed high degrees of satisfaction with the shared telehealth program. Patients especially liked the time they saved not having to travel to see a specialist, and a large majority agreed that the visits were “as good as” in-person visits, felt that their concerns were addressed appropriately during the virtual visit, expressed overall satisfaction, and said they would like to continue virtual visits.
Physicians expressed a high degree of satisfaction with the rheumatology didactic sessions and said that the sessions enhanced their knowledge of evaluating and managing or co-managing rheumatologic diseases, as well as helping them to feel comfortable about applying this knowledge to patient care.
Dr. Rivadeneira noted that the pilot study was limited by low levels of Piedmont Health Services physician participation (two out of 45 total participated in shared visits), and only three or four providers typically took part in each didactic session.
How to Improve?
In a follow-up study, the investigators asked Piedmont Health Services providers about barriers to rheumatology care, the most common and challenging diseases they encountered, how to improve the didactic components, and their perspectives on the pilot and how it may have affected referral patterns to rheumatology care.
The providers identified the cost of diagnostic evaluations and medications, transportation, long wait times, and language as the main barriers to patient access of rheumatology care.
“Additionally, over a third of them encountered patients on a weekly basis that were overdue for a visit with a rheumatologist,” Dr. Rivadeneira said.
“Direct participation in the physical exam by the primary care provider enhances greatly, in my opinion, these telehealth visits. Focused didactic sessions, electronic handouts and/or quick access guides could empower more rural community providers to manage rheumatic diseases,” he concluded.
In the Q&A following the presentation, Laura Cappelli, MD, MHS, MS, associate professor of medicine in the division of rheumatology at Johns Hopkins School of Medicine in Baltimore, asked Dr. Rivadeneira how rheumatologists involved felt about the program and whether his team did any surveying or qualitative work with them.
“Just so you know, the rheumatologist was me,” he replied.
“I’m very picky about telemedicine,” he continued. “I don’t like it, I prefer, as most of us do, to have the patient there. But having the provider there, doing the exam, and you guiding them — I can ask, ‘Did you check their joints? Did you check their strength?’ — makes a huge difference and makes me feel comfortable with the sessions.”
Dr. Rivadeneira added that if a particular case was too complex or too vague to adequately assess via telehealth, he would arrange to see the patient in person.
The project was supported by the Arthritis Foundation. Dr. Rivadeneira and Dr. Cappelli reported no conflicts of interest.
A version of this article appeared on Medscape.com.
Even in large urban areas there aren’t enough rheumatologists to go around, and as a 2015 American College of Rheumatology workforce study projected, the number of rheumatology providers is expected to drop by 25% by the year 2030, while the demand for patient care in rheumatology is expected to increase by more than 100%.
The shortage of rheumatology care is even more acute in rural areas, but as a pilot project supported by the Arthritis Foundation shows, linking rheumatologists to health centers in remote and underserved locations via telehealth can help community providers improve care for patients with rheumatic diseases.
The novel collaborative model was described by Alfredo Rivadeneira, MD, professor of medicine in the division of rheumatology, allergy, and immunology at the University of North Carolina (UNC) School of Medicine in Chapel Hill, North Carolina.
“We found that this pilot, a unique partnership in North Carolina, improves access to rheumatology care to a rural population with high satisfaction scores. It underlines the importance of seeking collaboration with community providers when implementing these programs. It also allows timely specialty care and alleviates the barriers relating to transportation, insurance coverage, and telecommunication challenges,” he said at the 2024 Rheumatoid Arthritis Research Summit presented by the Arthritis Foundation and the Hospital for Special Surgery in New York City.
Too Many Patients, Too Few Rheumatologists
Access to health is challenging for people from traditionally underserved racial and ethnic backgrounds, especially in states such as North Carolina, where 40% of the population lives in rural counties, which have higher age-adjusted mortality than more densely populated areas of the state, Dr. Rivadeneira said.
In addition, 42% of the North Carolina residents seen at the state’s 42 Federally Qualified Health Centers (FQHCs) don’t have health insurance, which is higher than the average of 23% uninsured seen at FQHCs in other states.
There are currently approximately 250 rheumatology providers in North Carolina, the majority of whom work in the states’ three academic medical centers. Currently, North Carolina has an estimated population of 10 million people, which is projected to increase to 11.7 million by 2030. And by 2030, 20% of North Carolinians will be aged ≥ 65 years, Dr. Rivadeneira said, highlighting the need for expanded rheumatology care.
Although telehealth services could be an option for expanding services to underserved communities, only 14 of the 42 FQHCs in the state use telehealth and only on a limited basis because it is not sufficiently reimbursed.
Rivadeneira pointed to a 2022 study that showed how patients with rheumatic and musculoskeletal disease patients in North Carolina were less likely to use online patient portals if they lived in rural areas; came from racial or ethnic minority backgrounds; were older, men, had lower economic status (Medicaid enrollment or uninsured); or spoke a language other than English as their primary tongue.
Pilot Project
To help smooth out some of the above-mentioned disparities, Dr. Rivadeneira and colleagues, in collaboration with the Arthritis Foundation, started a pilot project in 2022 designed to enhance access to rheumatology specialty care for rural residents through a shared telehealth model between the UNC rheumatology clinic and two separate Piedmont Health Services clinics in rural areas.
The project includes tailored educational sessions designed to empower Piedmont Health Services providers for evaluating and managing patients with rheumatic diseases.
Patients with prior diagnoses of rheumatologic diseases who were lost to rheumatology specialty care follow-up and those with new rheumatic symptoms who had transportation and/or financial barriers to receiving specialty care are triaged to the shared telemedicine visits.
Providers conduct monthly clinic sessions via shared visits between the on-site Piedmont Health Services provider and patients, with off-site UNC rheumatology fellows and attending physicians connected virtually.
The educational component of the project includes monthly didactic sessions offered to all Piedmont Health Services providers across 12 locations.
The topics that were chosen cover the most common rheumatologic conditions seen by community providers, including evaluating pain from a rheumatology perspective; using antinuclear antibodies and other serologies; evaluating and managing rheumatoid arthritis, lupus, gout, giant cell arteritis, polymyalgia rheumatica, and osteoarthritis; and methotrexate management and complications.
“One of the aspects of this pilot that I want to emphasize is the importance of having the generalists with the patient, relaying the objective data, especially the physical exam, and that’s one of the great features of this model. It also provides a stable platform for telehealth to the individual patients, as many of these patients don’t have access to health technology,” Dr. Rivadeneira said.
Thumbs Up
Both patients and general practitioners in the Piedmont Health system expressed high degrees of satisfaction with the shared telehealth program. Patients especially liked the time they saved not having to travel to see a specialist, and a large majority agreed that the visits were “as good as” in-person visits, felt that their concerns were addressed appropriately during the virtual visit, expressed overall satisfaction, and said they would like to continue virtual visits.
Physicians expressed a high degree of satisfaction with the rheumatology didactic sessions and said that the sessions enhanced their knowledge of evaluating and managing or co-managing rheumatologic diseases, as well as helping them to feel comfortable about applying this knowledge to patient care.
Dr. Rivadeneira noted that the pilot study was limited by low levels of Piedmont Health Services physician participation (two out of 45 total participated in shared visits), and only three or four providers typically took part in each didactic session.
How to Improve?
In a follow-up study, the investigators asked Piedmont Health Services providers about barriers to rheumatology care, the most common and challenging diseases they encountered, how to improve the didactic components, and their perspectives on the pilot and how it may have affected referral patterns to rheumatology care.
The providers identified the cost of diagnostic evaluations and medications, transportation, long wait times, and language as the main barriers to patient access of rheumatology care.
“Additionally, over a third of them encountered patients on a weekly basis that were overdue for a visit with a rheumatologist,” Dr. Rivadeneira said.
“Direct participation in the physical exam by the primary care provider enhances greatly, in my opinion, these telehealth visits. Focused didactic sessions, electronic handouts and/or quick access guides could empower more rural community providers to manage rheumatic diseases,” he concluded.
In the Q&A following the presentation, Laura Cappelli, MD, MHS, MS, associate professor of medicine in the division of rheumatology at Johns Hopkins School of Medicine in Baltimore, asked Dr. Rivadeneira how rheumatologists involved felt about the program and whether his team did any surveying or qualitative work with them.
“Just so you know, the rheumatologist was me,” he replied.
“I’m very picky about telemedicine,” he continued. “I don’t like it, I prefer, as most of us do, to have the patient there. But having the provider there, doing the exam, and you guiding them — I can ask, ‘Did you check their joints? Did you check their strength?’ — makes a huge difference and makes me feel comfortable with the sessions.”
Dr. Rivadeneira added that if a particular case was too complex or too vague to adequately assess via telehealth, he would arrange to see the patient in person.
The project was supported by the Arthritis Foundation. Dr. Rivadeneira and Dr. Cappelli reported no conflicts of interest.
A version of this article appeared on Medscape.com.
Even in large urban areas there aren’t enough rheumatologists to go around, and as a 2015 American College of Rheumatology workforce study projected, the number of rheumatology providers is expected to drop by 25% by the year 2030, while the demand for patient care in rheumatology is expected to increase by more than 100%.
The shortage of rheumatology care is even more acute in rural areas, but as a pilot project supported by the Arthritis Foundation shows, linking rheumatologists to health centers in remote and underserved locations via telehealth can help community providers improve care for patients with rheumatic diseases.
The novel collaborative model was described by Alfredo Rivadeneira, MD, professor of medicine in the division of rheumatology, allergy, and immunology at the University of North Carolina (UNC) School of Medicine in Chapel Hill, North Carolina.
“We found that this pilot, a unique partnership in North Carolina, improves access to rheumatology care to a rural population with high satisfaction scores. It underlines the importance of seeking collaboration with community providers when implementing these programs. It also allows timely specialty care and alleviates the barriers relating to transportation, insurance coverage, and telecommunication challenges,” he said at the 2024 Rheumatoid Arthritis Research Summit presented by the Arthritis Foundation and the Hospital for Special Surgery in New York City.
Too Many Patients, Too Few Rheumatologists
Access to health is challenging for people from traditionally underserved racial and ethnic backgrounds, especially in states such as North Carolina, where 40% of the population lives in rural counties, which have higher age-adjusted mortality than more densely populated areas of the state, Dr. Rivadeneira said.
In addition, 42% of the North Carolina residents seen at the state’s 42 Federally Qualified Health Centers (FQHCs) don’t have health insurance, which is higher than the average of 23% uninsured seen at FQHCs in other states.
There are currently approximately 250 rheumatology providers in North Carolina, the majority of whom work in the states’ three academic medical centers. Currently, North Carolina has an estimated population of 10 million people, which is projected to increase to 11.7 million by 2030. And by 2030, 20% of North Carolinians will be aged ≥ 65 years, Dr. Rivadeneira said, highlighting the need for expanded rheumatology care.
Although telehealth services could be an option for expanding services to underserved communities, only 14 of the 42 FQHCs in the state use telehealth and only on a limited basis because it is not sufficiently reimbursed.
Rivadeneira pointed to a 2022 study that showed how patients with rheumatic and musculoskeletal disease patients in North Carolina were less likely to use online patient portals if they lived in rural areas; came from racial or ethnic minority backgrounds; were older, men, had lower economic status (Medicaid enrollment or uninsured); or spoke a language other than English as their primary tongue.
Pilot Project
To help smooth out some of the above-mentioned disparities, Dr. Rivadeneira and colleagues, in collaboration with the Arthritis Foundation, started a pilot project in 2022 designed to enhance access to rheumatology specialty care for rural residents through a shared telehealth model between the UNC rheumatology clinic and two separate Piedmont Health Services clinics in rural areas.
The project includes tailored educational sessions designed to empower Piedmont Health Services providers for evaluating and managing patients with rheumatic diseases.
Patients with prior diagnoses of rheumatologic diseases who were lost to rheumatology specialty care follow-up and those with new rheumatic symptoms who had transportation and/or financial barriers to receiving specialty care are triaged to the shared telemedicine visits.
Providers conduct monthly clinic sessions via shared visits between the on-site Piedmont Health Services provider and patients, with off-site UNC rheumatology fellows and attending physicians connected virtually.
The educational component of the project includes monthly didactic sessions offered to all Piedmont Health Services providers across 12 locations.
The topics that were chosen cover the most common rheumatologic conditions seen by community providers, including evaluating pain from a rheumatology perspective; using antinuclear antibodies and other serologies; evaluating and managing rheumatoid arthritis, lupus, gout, giant cell arteritis, polymyalgia rheumatica, and osteoarthritis; and methotrexate management and complications.
“One of the aspects of this pilot that I want to emphasize is the importance of having the generalists with the patient, relaying the objective data, especially the physical exam, and that’s one of the great features of this model. It also provides a stable platform for telehealth to the individual patients, as many of these patients don’t have access to health technology,” Dr. Rivadeneira said.
Thumbs Up
Both patients and general practitioners in the Piedmont Health system expressed high degrees of satisfaction with the shared telehealth program. Patients especially liked the time they saved not having to travel to see a specialist, and a large majority agreed that the visits were “as good as” in-person visits, felt that their concerns were addressed appropriately during the virtual visit, expressed overall satisfaction, and said they would like to continue virtual visits.
Physicians expressed a high degree of satisfaction with the rheumatology didactic sessions and said that the sessions enhanced their knowledge of evaluating and managing or co-managing rheumatologic diseases, as well as helping them to feel comfortable about applying this knowledge to patient care.
Dr. Rivadeneira noted that the pilot study was limited by low levels of Piedmont Health Services physician participation (two out of 45 total participated in shared visits), and only three or four providers typically took part in each didactic session.
How to Improve?
In a follow-up study, the investigators asked Piedmont Health Services providers about barriers to rheumatology care, the most common and challenging diseases they encountered, how to improve the didactic components, and their perspectives on the pilot and how it may have affected referral patterns to rheumatology care.
The providers identified the cost of diagnostic evaluations and medications, transportation, long wait times, and language as the main barriers to patient access of rheumatology care.
“Additionally, over a third of them encountered patients on a weekly basis that were overdue for a visit with a rheumatologist,” Dr. Rivadeneira said.
“Direct participation in the physical exam by the primary care provider enhances greatly, in my opinion, these telehealth visits. Focused didactic sessions, electronic handouts and/or quick access guides could empower more rural community providers to manage rheumatic diseases,” he concluded.
In the Q&A following the presentation, Laura Cappelli, MD, MHS, MS, associate professor of medicine in the division of rheumatology at Johns Hopkins School of Medicine in Baltimore, asked Dr. Rivadeneira how rheumatologists involved felt about the program and whether his team did any surveying or qualitative work with them.
“Just so you know, the rheumatologist was me,” he replied.
“I’m very picky about telemedicine,” he continued. “I don’t like it, I prefer, as most of us do, to have the patient there. But having the provider there, doing the exam, and you guiding them — I can ask, ‘Did you check their joints? Did you check their strength?’ — makes a huge difference and makes me feel comfortable with the sessions.”
Dr. Rivadeneira added that if a particular case was too complex or too vague to adequately assess via telehealth, he would arrange to see the patient in person.
The project was supported by the Arthritis Foundation. Dr. Rivadeneira and Dr. Cappelli reported no conflicts of interest.
A version of this article appeared on Medscape.com.
FROM RA SUMMIT 2024
Second Ustekinumab Biosimilar Gets FDA Approval
The US Food and Drug Administration (FDA) has approved the biosimilar ustekinumab-aekn (Selarsdi) for the treatment of moderate to severe plaque psoriasis and psoriatic arthritis in adults and pediatric patients aged 6 years or older.
This is the second ustekinumab biosimilar approved by the regulatory agency and is the second biosimilar approval in the United States for the Icelandic pharmaceutical company Alvotech in partnership with Teva Pharmaceuticals.
Ustekinumab (Stelara) is a human monoclonal antibody targeting interleukin (IL)–12 and IL-23. The drug, manufactured by Johnson & Johnson, totaled nearly $7 billion in sales in 2023 alone, according a press release.
“Bringing Selarsdi to market in the US early next year presents a significant opportunity to improve patient access to a vital biologic in inflammatory disease and contribute to the reduction of inflationary pressure in healthcare costs,” the chairman and CEO of Alvotech said in the release.
The first ustekinumab biosimilar, ustekinumab-auub (Wezlana), was approved by the FDA in on October 31, 2023 and is interchangeable with the reference product. This allows pharmacists to substitute the biosimilar for the reference product without involving the prescribing clinician (according to state law). Besides psoriasis and psoriatic arthritis, ustekinumab-auub was also approved for treating moderate to severely active Crohn’s disease and ulcerative colitis. Ustekinumab-aekn does not have an interchangeability designation and was not approved for Crohn’s disease or ulcerative colitis.
The approval of ustekinumab-aekn was based on two clinical studies. A randomized, double blind, multicenter, 52-week study of 581 patients with moderate to severe plaque psoriasis demonstrated that the biosimilar was as effective as the reference product, with equivalent safety and immunogenicity profiles. A phase 1, randomized, double-blind, single-dose, parallel-group, three-arm study also compared the pharmacokinetic profile of the biosimilar to ustekinumab in 294 healthy adults.
Ustekinumab-aekn is expected to be marketed in the United States on or after February 21, 2025 per a settlement and license agreement with Johnson & Johnson.
A version of this article appeared on Medscape.com.
The US Food and Drug Administration (FDA) has approved the biosimilar ustekinumab-aekn (Selarsdi) for the treatment of moderate to severe plaque psoriasis and psoriatic arthritis in adults and pediatric patients aged 6 years or older.
This is the second ustekinumab biosimilar approved by the regulatory agency and is the second biosimilar approval in the United States for the Icelandic pharmaceutical company Alvotech in partnership with Teva Pharmaceuticals.
Ustekinumab (Stelara) is a human monoclonal antibody targeting interleukin (IL)–12 and IL-23. The drug, manufactured by Johnson & Johnson, totaled nearly $7 billion in sales in 2023 alone, according a press release.
“Bringing Selarsdi to market in the US early next year presents a significant opportunity to improve patient access to a vital biologic in inflammatory disease and contribute to the reduction of inflationary pressure in healthcare costs,” the chairman and CEO of Alvotech said in the release.
The first ustekinumab biosimilar, ustekinumab-auub (Wezlana), was approved by the FDA in on October 31, 2023 and is interchangeable with the reference product. This allows pharmacists to substitute the biosimilar for the reference product without involving the prescribing clinician (according to state law). Besides psoriasis and psoriatic arthritis, ustekinumab-auub was also approved for treating moderate to severely active Crohn’s disease and ulcerative colitis. Ustekinumab-aekn does not have an interchangeability designation and was not approved for Crohn’s disease or ulcerative colitis.
The approval of ustekinumab-aekn was based on two clinical studies. A randomized, double blind, multicenter, 52-week study of 581 patients with moderate to severe plaque psoriasis demonstrated that the biosimilar was as effective as the reference product, with equivalent safety and immunogenicity profiles. A phase 1, randomized, double-blind, single-dose, parallel-group, three-arm study also compared the pharmacokinetic profile of the biosimilar to ustekinumab in 294 healthy adults.
Ustekinumab-aekn is expected to be marketed in the United States on or after February 21, 2025 per a settlement and license agreement with Johnson & Johnson.
A version of this article appeared on Medscape.com.
The US Food and Drug Administration (FDA) has approved the biosimilar ustekinumab-aekn (Selarsdi) for the treatment of moderate to severe plaque psoriasis and psoriatic arthritis in adults and pediatric patients aged 6 years or older.
This is the second ustekinumab biosimilar approved by the regulatory agency and is the second biosimilar approval in the United States for the Icelandic pharmaceutical company Alvotech in partnership with Teva Pharmaceuticals.
Ustekinumab (Stelara) is a human monoclonal antibody targeting interleukin (IL)–12 and IL-23. The drug, manufactured by Johnson & Johnson, totaled nearly $7 billion in sales in 2023 alone, according a press release.
“Bringing Selarsdi to market in the US early next year presents a significant opportunity to improve patient access to a vital biologic in inflammatory disease and contribute to the reduction of inflationary pressure in healthcare costs,” the chairman and CEO of Alvotech said in the release.
The first ustekinumab biosimilar, ustekinumab-auub (Wezlana), was approved by the FDA in on October 31, 2023 and is interchangeable with the reference product. This allows pharmacists to substitute the biosimilar for the reference product without involving the prescribing clinician (according to state law). Besides psoriasis and psoriatic arthritis, ustekinumab-auub was also approved for treating moderate to severely active Crohn’s disease and ulcerative colitis. Ustekinumab-aekn does not have an interchangeability designation and was not approved for Crohn’s disease or ulcerative colitis.
The approval of ustekinumab-aekn was based on two clinical studies. A randomized, double blind, multicenter, 52-week study of 581 patients with moderate to severe plaque psoriasis demonstrated that the biosimilar was as effective as the reference product, with equivalent safety and immunogenicity profiles. A phase 1, randomized, double-blind, single-dose, parallel-group, three-arm study also compared the pharmacokinetic profile of the biosimilar to ustekinumab in 294 healthy adults.
Ustekinumab-aekn is expected to be marketed in the United States on or after February 21, 2025 per a settlement and license agreement with Johnson & Johnson.
A version of this article appeared on Medscape.com.
Physicians Own Less Than Half of US Practices; Federal Agencies Want Outside Input
Physician practice ownership by corporations, including health insurers, private equity firms, and large pharmacy chains, reached 30.1% as of January for the first time surpassing ownership by hospitals and health systems (28.4%), according to a new report.
As a result, about three in five physician practices are now owned by nonphysicians.
In early 2020, corporations owned just about 17% of US medical practices, while hospitals and health systems owned about 25%, according to the report released Thursday by nonprofit Physician Advocacy Institute (PAI). But corporate ownership of medical groups surged during the pandemic.
These trends raise questions about how best to protect patients and physicians in a changing employment landscape, said Kelly Kenney, PAI’s chief executive officer, in a statement.
“Corporate entities are assuming control of physician practices and changing the face of medicine in the United States with little to no scrutiny from regulators,” Ms. Kenney said.
The research, conducted by consulting group Avalere for PAI, used the IQVIA OneKey database that contains physician and practice location information on hospital and health system ownership.
By 2022-2023, there was a 7.3% increase in the percentage of practices owned by hospitals and 5.9% increase in the percentage of physicians employed by these organizations, PAI said. In the same time frame, there was an 11% increase in the percentage of practices owned by corporations and a 3.0% increase in the percentage of physicians employed by these entities.
“Physicians have an ethical responsibility to their patients’ health,” Ms. Kenney said. “Corporate entities have a fiduciary responsibility to their shareholders and are motivated to put profits first…these interests can conflict with providing the best medical care to patients.”
Federal Scrutiny Increases
However, both federal and state regulators are paying more attention to what happens to patients and physicians when corporations acquire practices.
“Given recent trends, we are concerned that some transactions may generate profits for those firms at the expense of patients’ health, workers’ safety, quality of care, and affordable healthcare for patients and taxpayers,” said the Federal Trade Commission (FTC) and the Justice (DOJ) and Health and Human Services (HHS) departments.
This statement appears in those agencies’ joint request for information (RFI) announced in March. An RFI is a tool that federal agencies can use to gauge the level of both support and opposition they would face if they were to try to change policies. Public comments are due May 6.
Corporations and advocacy groups often submit detailed comments outlining reasons why the federal government should or should not act on an issue. But individuals also can make their case in this forum.
The FTC, DOJ, and HHS are looking broadly at consolidation in healthcare, but they also spell out potential concerns related to acquisition of physician practices.
For example, they asked clinicians and support staff to provide feedback about whether acquisitions lead to changes in:
- Take-home pay
- Staffing levels
- Workplace safety
- Compensation model (eg, from fixed salary to volume based)
- Policies regarding patient referrals
- Mix of patients
- The volume of patients
- The way providers practice medicine (eg, incentives, prescribing decisions, forced protocols, restrictions on time spent with patients, or mandatory coding practices)
- Administrative or managerial organization (eg, transition to a management services organization).
A version of this article appeared on Medscape.com.
Physician practice ownership by corporations, including health insurers, private equity firms, and large pharmacy chains, reached 30.1% as of January for the first time surpassing ownership by hospitals and health systems (28.4%), according to a new report.
As a result, about three in five physician practices are now owned by nonphysicians.
In early 2020, corporations owned just about 17% of US medical practices, while hospitals and health systems owned about 25%, according to the report released Thursday by nonprofit Physician Advocacy Institute (PAI). But corporate ownership of medical groups surged during the pandemic.
These trends raise questions about how best to protect patients and physicians in a changing employment landscape, said Kelly Kenney, PAI’s chief executive officer, in a statement.
“Corporate entities are assuming control of physician practices and changing the face of medicine in the United States with little to no scrutiny from regulators,” Ms. Kenney said.
The research, conducted by consulting group Avalere for PAI, used the IQVIA OneKey database that contains physician and practice location information on hospital and health system ownership.
By 2022-2023, there was a 7.3% increase in the percentage of practices owned by hospitals and 5.9% increase in the percentage of physicians employed by these organizations, PAI said. In the same time frame, there was an 11% increase in the percentage of practices owned by corporations and a 3.0% increase in the percentage of physicians employed by these entities.
“Physicians have an ethical responsibility to their patients’ health,” Ms. Kenney said. “Corporate entities have a fiduciary responsibility to their shareholders and are motivated to put profits first…these interests can conflict with providing the best medical care to patients.”
Federal Scrutiny Increases
However, both federal and state regulators are paying more attention to what happens to patients and physicians when corporations acquire practices.
“Given recent trends, we are concerned that some transactions may generate profits for those firms at the expense of patients’ health, workers’ safety, quality of care, and affordable healthcare for patients and taxpayers,” said the Federal Trade Commission (FTC) and the Justice (DOJ) and Health and Human Services (HHS) departments.
This statement appears in those agencies’ joint request for information (RFI) announced in March. An RFI is a tool that federal agencies can use to gauge the level of both support and opposition they would face if they were to try to change policies. Public comments are due May 6.
Corporations and advocacy groups often submit detailed comments outlining reasons why the federal government should or should not act on an issue. But individuals also can make their case in this forum.
The FTC, DOJ, and HHS are looking broadly at consolidation in healthcare, but they also spell out potential concerns related to acquisition of physician practices.
For example, they asked clinicians and support staff to provide feedback about whether acquisitions lead to changes in:
- Take-home pay
- Staffing levels
- Workplace safety
- Compensation model (eg, from fixed salary to volume based)
- Policies regarding patient referrals
- Mix of patients
- The volume of patients
- The way providers practice medicine (eg, incentives, prescribing decisions, forced protocols, restrictions on time spent with patients, or mandatory coding practices)
- Administrative or managerial organization (eg, transition to a management services organization).
A version of this article appeared on Medscape.com.
Physician practice ownership by corporations, including health insurers, private equity firms, and large pharmacy chains, reached 30.1% as of January for the first time surpassing ownership by hospitals and health systems (28.4%), according to a new report.
As a result, about three in five physician practices are now owned by nonphysicians.
In early 2020, corporations owned just about 17% of US medical practices, while hospitals and health systems owned about 25%, according to the report released Thursday by nonprofit Physician Advocacy Institute (PAI). But corporate ownership of medical groups surged during the pandemic.
These trends raise questions about how best to protect patients and physicians in a changing employment landscape, said Kelly Kenney, PAI’s chief executive officer, in a statement.
“Corporate entities are assuming control of physician practices and changing the face of medicine in the United States with little to no scrutiny from regulators,” Ms. Kenney said.
The research, conducted by consulting group Avalere for PAI, used the IQVIA OneKey database that contains physician and practice location information on hospital and health system ownership.
By 2022-2023, there was a 7.3% increase in the percentage of practices owned by hospitals and 5.9% increase in the percentage of physicians employed by these organizations, PAI said. In the same time frame, there was an 11% increase in the percentage of practices owned by corporations and a 3.0% increase in the percentage of physicians employed by these entities.
“Physicians have an ethical responsibility to their patients’ health,” Ms. Kenney said. “Corporate entities have a fiduciary responsibility to their shareholders and are motivated to put profits first…these interests can conflict with providing the best medical care to patients.”
Federal Scrutiny Increases
However, both federal and state regulators are paying more attention to what happens to patients and physicians when corporations acquire practices.
“Given recent trends, we are concerned that some transactions may generate profits for those firms at the expense of patients’ health, workers’ safety, quality of care, and affordable healthcare for patients and taxpayers,” said the Federal Trade Commission (FTC) and the Justice (DOJ) and Health and Human Services (HHS) departments.
This statement appears in those agencies’ joint request for information (RFI) announced in March. An RFI is a tool that federal agencies can use to gauge the level of both support and opposition they would face if they were to try to change policies. Public comments are due May 6.
Corporations and advocacy groups often submit detailed comments outlining reasons why the federal government should or should not act on an issue. But individuals also can make their case in this forum.
The FTC, DOJ, and HHS are looking broadly at consolidation in healthcare, but they also spell out potential concerns related to acquisition of physician practices.
For example, they asked clinicians and support staff to provide feedback about whether acquisitions lead to changes in:
- Take-home pay
- Staffing levels
- Workplace safety
- Compensation model (eg, from fixed salary to volume based)
- Policies regarding patient referrals
- Mix of patients
- The volume of patients
- The way providers practice medicine (eg, incentives, prescribing decisions, forced protocols, restrictions on time spent with patients, or mandatory coding practices)
- Administrative or managerial organization (eg, transition to a management services organization).
A version of this article appeared on Medscape.com.
Could Modifying Gut Microbiota Enhance Response to Methotrexate in RA?
If your gut is telling you that your disease-modifying antirheumatic drugs (DMARDs) aren’t working as well as they should, listen to it.
That’s the advice of Rebecca B. Blank, MD, PhD, a rheumatologist at NYU Langone Health in New York City, who studies methods for modulating the gut microbiome to enhance DMARD efficacy for patients with rheumatoid arthritis (RA).
“The baseline gut microbiome can predict patient responsiveness to methotrexate,” said Dr. Blank at the 2024 Rheumatoid Arthritis Research Summit, presented by the Arthritis Foundation and the Hospital for Special Surgery in New York City.
Dr. Blank and colleagues are investigating how the intestinal microbiome may influence drug metabolism and the therapeutic potential of short-chain fatty acids for improving the efficacy of methotrexate in patients with RA.
Mucosal Barrier Disruption
There are myriad factors contributing to the development and progression of RA, including dysbiosis, or disruption, of the mucosal barrier, Dr. Blank explained.
“Dysbiosis can be detected in at-risk individuals before clinical signs of rheumatoid arthritis even occur,” she said.
Dr. Blank cited a 2021 study of the gut-joint axis in RA,which indicated that subclinical inflammation in the oral, gut, and/or lung mucosa may lead to inflammatory arthritis.
“When there’s a break in the mucosal barrier, either bacteria or their bacterial products can translocate into the lamina propria and then lead to an inflammatory T-cell response, and in addition, bacteria or their products can induce auto-antibody formation, which can then lead to joint inflammation,” she said.
Dr. Blank and colleagues, as well as other research groups, showed that gut bacterial colonization by Prevotella copri can induce an inflammatory response in gut lamina propria, and that people with RA have increased abundance of P copri relative to people without RA.
DMARD Resistance
To see whether microbial dysbiosis might play a role in DMARD-resistant RA, Dr. Blank and her team looked at patients with new-onset RA who were scheduled for treatment with methotrexate as their first-line medication. They classified responders as those patients with a change in Disease Activity Score in 28 joints (DAS28) of at least 1.8 points.
They then conducted 16S rRNA sequencing and shotgun sequencing on patient fecal samples taken at baseline to determine whether baseline microbiome differences might contribute to responses to methotrexate.
“And so indeed, we were able to find a human gut microbial signature that predicted methotrexate responsiveness in these baseline microbiome samples,” Dr. Blank said.
They identified 462 differences in gene orthologs (ie, genes preserved during evolution and speciation) that differed between responders and nonresponders, narrowed the list down to the top 38, and then developed a predictive model for response to methotrexate with an area under the receiver operating characteristic curve of 0.84.
The investigators then cultured fecal baseline samples with methotrexate to see how levels of the drug would be affected over time and found that samples from nonresponders metabolized methotrexate at a faster rate than samples from patients who had clinical responses to the drug.
Their work was further supported by colleagues at the University of California San Francisco, who found evidence in mouse models to suggest that microbial metabolism plays a role in methotrexate levels in plasma.
Modulating the Gut
“Our next question was: Can we modulate the gut microbiome to improve methotrexate efficacy?” Dr. Blank said.
They considered probiotics and prebiotics as possible means for modulating gut microbiota, but evidence of efficacy for these agents has been decidedly mixed, she noted.
Instead, the investigators focused on short-chain fatty acids, gut microbial fermentation byproducts of indigestible carbohydrates, which have been demonstrated to help improve gut mucosal barrier integrity and promote a more tolerant immune response.
One such short-chain fatty acid, butyrate, is produced through microbial fermentation of dietary fiber in the colon; it is available in various foods and in supplement form.
Butyrate has been shown to ameliorate inflammatory arthritis in a collagen-induced arthritis model, and in this model, methotrexate efficacy was increased with the addition of butyrate or butyrate-producing bacterial species.
Dr. Blank and colleagues compared patients with new-onset RA treated with methotrexate alone or methotrexate plus butyrate for 4 months and looked at up to 2 months of methotrexate plus butyrate treatment in patients who had suboptimal response to methotrexate alone.
In preliminary analyses, they found that at baseline, fecal butyrate was significantly elevated in methotrexate responders compared with in nonresponders. In addition, in the new-onset RA cohort, they saw that the 4-month responsiveness rate was 52.6% for those treated with methotrexate compared with 64.7% for those treated with methotrexate plus butyrate.
“Although this difference was not statistically significant, it’s exciting to think we may have an impact. What’s more, we were really excited to find that oral butyrate can lead to increased microbial diversity,” she said.
What Are You Measuring?
In the Q & A following the presentation, Clifton O. Bingham III, MD, director of the Johns Hopkins Arthritis Center in Baltimore, Maryland, commented that “the definitions of response and nonresponse are quite variable, depending on the studies that you use, and I think this is potentially a real problem for this entire line of investigation.”
He noted that the DAS28, as used by Dr. Blank and colleagues, was developed in 1993, and that American College of Rheumatology response criteria, employed by other investigators who also presented during the session, were developed in 1990.
“It was a very different world when those criteria and those response indices were developed for patients with a very different disease from what we know as RA today,” he said.
He added that “I see a tremendous need for the rheumatology community to reevaluate what we define as responders and nonresponders, so that in all of these studies that are being done around the world, there is one definition that we understand [for] someone who is doing better, responding, or not responding.”
Dr. Blank’s work is supported by NYU, the Arthritis Foundation, and the National Institute of Arthritis and Musculoskeletal and Skin Diseases. She reported having no conflicts of interest to disclose. Dr. Bingham had no relevant conflicts of interest to disclose.
A version of this article appeared on Medscape.com.
If your gut is telling you that your disease-modifying antirheumatic drugs (DMARDs) aren’t working as well as they should, listen to it.
That’s the advice of Rebecca B. Blank, MD, PhD, a rheumatologist at NYU Langone Health in New York City, who studies methods for modulating the gut microbiome to enhance DMARD efficacy for patients with rheumatoid arthritis (RA).
“The baseline gut microbiome can predict patient responsiveness to methotrexate,” said Dr. Blank at the 2024 Rheumatoid Arthritis Research Summit, presented by the Arthritis Foundation and the Hospital for Special Surgery in New York City.
Dr. Blank and colleagues are investigating how the intestinal microbiome may influence drug metabolism and the therapeutic potential of short-chain fatty acids for improving the efficacy of methotrexate in patients with RA.
Mucosal Barrier Disruption
There are myriad factors contributing to the development and progression of RA, including dysbiosis, or disruption, of the mucosal barrier, Dr. Blank explained.
“Dysbiosis can be detected in at-risk individuals before clinical signs of rheumatoid arthritis even occur,” she said.
Dr. Blank cited a 2021 study of the gut-joint axis in RA,which indicated that subclinical inflammation in the oral, gut, and/or lung mucosa may lead to inflammatory arthritis.
“When there’s a break in the mucosal barrier, either bacteria or their bacterial products can translocate into the lamina propria and then lead to an inflammatory T-cell response, and in addition, bacteria or their products can induce auto-antibody formation, which can then lead to joint inflammation,” she said.
Dr. Blank and colleagues, as well as other research groups, showed that gut bacterial colonization by Prevotella copri can induce an inflammatory response in gut lamina propria, and that people with RA have increased abundance of P copri relative to people without RA.
DMARD Resistance
To see whether microbial dysbiosis might play a role in DMARD-resistant RA, Dr. Blank and her team looked at patients with new-onset RA who were scheduled for treatment with methotrexate as their first-line medication. They classified responders as those patients with a change in Disease Activity Score in 28 joints (DAS28) of at least 1.8 points.
They then conducted 16S rRNA sequencing and shotgun sequencing on patient fecal samples taken at baseline to determine whether baseline microbiome differences might contribute to responses to methotrexate.
“And so indeed, we were able to find a human gut microbial signature that predicted methotrexate responsiveness in these baseline microbiome samples,” Dr. Blank said.
They identified 462 differences in gene orthologs (ie, genes preserved during evolution and speciation) that differed between responders and nonresponders, narrowed the list down to the top 38, and then developed a predictive model for response to methotrexate with an area under the receiver operating characteristic curve of 0.84.
The investigators then cultured fecal baseline samples with methotrexate to see how levels of the drug would be affected over time and found that samples from nonresponders metabolized methotrexate at a faster rate than samples from patients who had clinical responses to the drug.
Their work was further supported by colleagues at the University of California San Francisco, who found evidence in mouse models to suggest that microbial metabolism plays a role in methotrexate levels in plasma.
Modulating the Gut
“Our next question was: Can we modulate the gut microbiome to improve methotrexate efficacy?” Dr. Blank said.
They considered probiotics and prebiotics as possible means for modulating gut microbiota, but evidence of efficacy for these agents has been decidedly mixed, she noted.
Instead, the investigators focused on short-chain fatty acids, gut microbial fermentation byproducts of indigestible carbohydrates, which have been demonstrated to help improve gut mucosal barrier integrity and promote a more tolerant immune response.
One such short-chain fatty acid, butyrate, is produced through microbial fermentation of dietary fiber in the colon; it is available in various foods and in supplement form.
Butyrate has been shown to ameliorate inflammatory arthritis in a collagen-induced arthritis model, and in this model, methotrexate efficacy was increased with the addition of butyrate or butyrate-producing bacterial species.
Dr. Blank and colleagues compared patients with new-onset RA treated with methotrexate alone or methotrexate plus butyrate for 4 months and looked at up to 2 months of methotrexate plus butyrate treatment in patients who had suboptimal response to methotrexate alone.
In preliminary analyses, they found that at baseline, fecal butyrate was significantly elevated in methotrexate responders compared with in nonresponders. In addition, in the new-onset RA cohort, they saw that the 4-month responsiveness rate was 52.6% for those treated with methotrexate compared with 64.7% for those treated with methotrexate plus butyrate.
“Although this difference was not statistically significant, it’s exciting to think we may have an impact. What’s more, we were really excited to find that oral butyrate can lead to increased microbial diversity,” she said.
What Are You Measuring?
In the Q & A following the presentation, Clifton O. Bingham III, MD, director of the Johns Hopkins Arthritis Center in Baltimore, Maryland, commented that “the definitions of response and nonresponse are quite variable, depending on the studies that you use, and I think this is potentially a real problem for this entire line of investigation.”
He noted that the DAS28, as used by Dr. Blank and colleagues, was developed in 1993, and that American College of Rheumatology response criteria, employed by other investigators who also presented during the session, were developed in 1990.
“It was a very different world when those criteria and those response indices were developed for patients with a very different disease from what we know as RA today,” he said.
He added that “I see a tremendous need for the rheumatology community to reevaluate what we define as responders and nonresponders, so that in all of these studies that are being done around the world, there is one definition that we understand [for] someone who is doing better, responding, or not responding.”
Dr. Blank’s work is supported by NYU, the Arthritis Foundation, and the National Institute of Arthritis and Musculoskeletal and Skin Diseases. She reported having no conflicts of interest to disclose. Dr. Bingham had no relevant conflicts of interest to disclose.
A version of this article appeared on Medscape.com.
If your gut is telling you that your disease-modifying antirheumatic drugs (DMARDs) aren’t working as well as they should, listen to it.
That’s the advice of Rebecca B. Blank, MD, PhD, a rheumatologist at NYU Langone Health in New York City, who studies methods for modulating the gut microbiome to enhance DMARD efficacy for patients with rheumatoid arthritis (RA).
“The baseline gut microbiome can predict patient responsiveness to methotrexate,” said Dr. Blank at the 2024 Rheumatoid Arthritis Research Summit, presented by the Arthritis Foundation and the Hospital for Special Surgery in New York City.
Dr. Blank and colleagues are investigating how the intestinal microbiome may influence drug metabolism and the therapeutic potential of short-chain fatty acids for improving the efficacy of methotrexate in patients with RA.
Mucosal Barrier Disruption
There are myriad factors contributing to the development and progression of RA, including dysbiosis, or disruption, of the mucosal barrier, Dr. Blank explained.
“Dysbiosis can be detected in at-risk individuals before clinical signs of rheumatoid arthritis even occur,” she said.
Dr. Blank cited a 2021 study of the gut-joint axis in RA,which indicated that subclinical inflammation in the oral, gut, and/or lung mucosa may lead to inflammatory arthritis.
“When there’s a break in the mucosal barrier, either bacteria or their bacterial products can translocate into the lamina propria and then lead to an inflammatory T-cell response, and in addition, bacteria or their products can induce auto-antibody formation, which can then lead to joint inflammation,” she said.
Dr. Blank and colleagues, as well as other research groups, showed that gut bacterial colonization by Prevotella copri can induce an inflammatory response in gut lamina propria, and that people with RA have increased abundance of P copri relative to people without RA.
DMARD Resistance
To see whether microbial dysbiosis might play a role in DMARD-resistant RA, Dr. Blank and her team looked at patients with new-onset RA who were scheduled for treatment with methotrexate as their first-line medication. They classified responders as those patients with a change in Disease Activity Score in 28 joints (DAS28) of at least 1.8 points.
They then conducted 16S rRNA sequencing and shotgun sequencing on patient fecal samples taken at baseline to determine whether baseline microbiome differences might contribute to responses to methotrexate.
“And so indeed, we were able to find a human gut microbial signature that predicted methotrexate responsiveness in these baseline microbiome samples,” Dr. Blank said.
They identified 462 differences in gene orthologs (ie, genes preserved during evolution and speciation) that differed between responders and nonresponders, narrowed the list down to the top 38, and then developed a predictive model for response to methotrexate with an area under the receiver operating characteristic curve of 0.84.
The investigators then cultured fecal baseline samples with methotrexate to see how levels of the drug would be affected over time and found that samples from nonresponders metabolized methotrexate at a faster rate than samples from patients who had clinical responses to the drug.
Their work was further supported by colleagues at the University of California San Francisco, who found evidence in mouse models to suggest that microbial metabolism plays a role in methotrexate levels in plasma.
Modulating the Gut
“Our next question was: Can we modulate the gut microbiome to improve methotrexate efficacy?” Dr. Blank said.
They considered probiotics and prebiotics as possible means for modulating gut microbiota, but evidence of efficacy for these agents has been decidedly mixed, she noted.
Instead, the investigators focused on short-chain fatty acids, gut microbial fermentation byproducts of indigestible carbohydrates, which have been demonstrated to help improve gut mucosal barrier integrity and promote a more tolerant immune response.
One such short-chain fatty acid, butyrate, is produced through microbial fermentation of dietary fiber in the colon; it is available in various foods and in supplement form.
Butyrate has been shown to ameliorate inflammatory arthritis in a collagen-induced arthritis model, and in this model, methotrexate efficacy was increased with the addition of butyrate or butyrate-producing bacterial species.
Dr. Blank and colleagues compared patients with new-onset RA treated with methotrexate alone or methotrexate plus butyrate for 4 months and looked at up to 2 months of methotrexate plus butyrate treatment in patients who had suboptimal response to methotrexate alone.
In preliminary analyses, they found that at baseline, fecal butyrate was significantly elevated in methotrexate responders compared with in nonresponders. In addition, in the new-onset RA cohort, they saw that the 4-month responsiveness rate was 52.6% for those treated with methotrexate compared with 64.7% for those treated with methotrexate plus butyrate.
“Although this difference was not statistically significant, it’s exciting to think we may have an impact. What’s more, we were really excited to find that oral butyrate can lead to increased microbial diversity,” she said.
What Are You Measuring?
In the Q & A following the presentation, Clifton O. Bingham III, MD, director of the Johns Hopkins Arthritis Center in Baltimore, Maryland, commented that “the definitions of response and nonresponse are quite variable, depending on the studies that you use, and I think this is potentially a real problem for this entire line of investigation.”
He noted that the DAS28, as used by Dr. Blank and colleagues, was developed in 1993, and that American College of Rheumatology response criteria, employed by other investigators who also presented during the session, were developed in 1990.
“It was a very different world when those criteria and those response indices were developed for patients with a very different disease from what we know as RA today,” he said.
He added that “I see a tremendous need for the rheumatology community to reevaluate what we define as responders and nonresponders, so that in all of these studies that are being done around the world, there is one definition that we understand [for] someone who is doing better, responding, or not responding.”
Dr. Blank’s work is supported by NYU, the Arthritis Foundation, and the National Institute of Arthritis and Musculoskeletal and Skin Diseases. She reported having no conflicts of interest to disclose. Dr. Bingham had no relevant conflicts of interest to disclose.
A version of this article appeared on Medscape.com.
FROM RA SUMMIT 2024
Cannabis Constituent May Be Key to Easing THC-Induced Anxiety
, new data from a small study suggested.
Participants who inhaled vaporized D-limonene and THC reported significantly greater decreases in anxiogenic effects than did people who received either component alone or a placebo. Reductions were greater as the dose of the D-limonene was increased.
Investigators noted that the findings could have implications for the use of medicinal or recreational cannabis, which has increased in recent years due to state legalization efforts.
“People use cannabis to help reduce anxiety, depression, and posttraumatic stress disorder, but since THC levels vary widely, if a person overshoots their tolerance of THC, cannabis can induce anxiety rather than relieve it,” senior investigator Ryan Vandrey, PhD, professor of psychiatry and behavioral sciences, Johns Hopkins School of Medicine, Baltimore, said in a news release.
“Our study demonstrates that D-limonene can modulate the effects of THC in a meaningful way and make THC more tolerable to people using it for both therapeutic and non-therapeutic purposes,” he added.
The study was published online in Drug and Alcohol Dependence.
Entourage Theory
Cannabis legalization has opened the door to an increased range of medicinal and nonmedicinal uses, but its benefits can be limited by the anxiety and panic some people experience with its use, investigators noted.
Many cannabis plants have been bred to contain higher concentrations of THC, with some dispensaries selling cannabis with more than 20%-30% THC. The plants often include cannabidiol, “minor” cannabinoids, and terpenes, such as D-limonene.
Prior studies pointed to THC as the cause of acute behavioral and psychoactive effects some cannabis users experience. However, a new, untested theory, the “cannabis entourage effect theory,” suggested other components in cannabis, including D-limonene, may contribute to the anxiogenic symptoms.
“We were motivated by scientific publications that hypothesized D-limonene can attenuate the acute anxiogenic effects of cannabis, but for which empirical data did not exist,” Dr. Vandrey said.
Investigators designed a small double-blind, within-subjects crossover study of 20 healthy adults (median age, 26 years; 50% men). About half of participants were Caucasian/non-Hispanic, 30% African American/non-Hispanic, 10% Caucasian/Hispanic, and 10% Asian/non-Hispanic.
All participants completed nine outpatient drug administration sessions, during which they inhaled vaporized D-limonene alone (1 or 5 mg), THC alone (15 or 30 mg), the same doses of THC and D-limonene together, or placebo.
Primary outcomes included subjective drug effects, measured with the Drug Effect Questionnaire (DEQ) and the 20-item state subscale of the State-Trait Anxiety Inventory (STAI-S). Investigators also measured cognitive/psychomotor performance with the Digit Symbol Substitution Task (DSST) and the Paced Serial Addition Task.
Vital signs such as heart rate, systolic blood pressure (SBP), diastolic blood pressure (DBP), and plasma D-limonene and THC concentrations were also tracked.
Participants’ responses were measured at baseline and then an additional nine times after initial exposure over the course of each 6-hour test session. Blood and urine samples were collected from participants before, during, and after each session.
First Evidence
There were no significant differences in outcomes between the D-limonene alone and placebo groups.
Receipt of 15- and 30-mg doses of THC alone was associated with subjective reports of acute cannabis exposure, including cognitive and physiological effects.
A treatment effect was observed for “anxious/nervous” (P < .01), “paranoid” (P < .01), and “heart racing” (P < .0001).
In planned comparisons, ratings of anxiety-like subjective effects qualitatively decreased as D-limonene dose increased, and concurrent administration of 30-mg THC plus 15-mg D-limonene significantly reduced ratings of “anxious/nervous” and “paranoid” on the DEQ compared to 30 mg of THC alone (P < .05).
Findings were similar on the composite score of the STAI-S, and although planned comparisons did not reach the threshold for statistical significance, reductions in anxiety approached significance in the THC plus D-limonene group compared with the THC alone condition (P = .08). The combination group also reported significantly lower subjective ratings of unpleasant drug effects than the THC alone group (P = .03).
In particular, a main effect of treatment was found for the anxious/nervous category on the DEQ (P < .01), as well as the “paranoid” (P < .01) and heart racing (P < .0001) categories.
On the other hand, ratings of anxious/nervous and paranoid categories were significantly lower in the 30-mg THC plus 15-mg D-limonene vs the 30-mg THC alone condition (P < .05, for all).
As for cognition, following drug administration, a significant main effect of treatment was observed for the DSST (P < .05), but no significant differences between THC and THC plus D-limonene combination conditions or between D-limonene alone and placebo were detected.
There were no differences within each THC dose and between D-limonene alone versus placebo conditions. Moreover, there were no main effects of treatment found for SBP or DBP.
The combination condition produced significantly greater concentrations of THC than the THC alone condition (P < .05).
“This study provides the first evidence that there are chemical constituents found naturally in the cannabis plant that can reduce some of the adverse effects of using delta-9-THC,” Dr. Vandrey said.
Although the exact mechanism by which vaporized D-limonene counters the anxiogenic effects of THC is unclear, “our best guess is that D-limonene is producing an anxiolytic effect on its own that is not mediated by cannabinoid receptors,” Dr. Vandrey said.
Significant Impact
Commenting on the research, Joshua Lile, PhD, professor, Department of Behavioral Science, University of Kentucky College of Medicine, Lexington, noted that the study seems to be the first of its kind to study the influence of terpene on THC response.
The research “makes a significant impact on our field,” and is “among the few controlled clinical studies that have demonstrated interactions between THC and other cannabis constituents, supporting the validity of the ‘entourage’ effect,” said Dr. Lile, who was not involved with the current research.
“This work is particularly important, given the unfounded claims sometimes made by the cannabis industry regarding the effects of different cannabis products,” he added.
Also commenting on the study, Ziva Cooper, PhD, professor and director of the UCLA Center for Cannabis and Cannabinoids, University of California Los Angeles, said the findings “have direct implications for improving the safety of cannabis, whether it’s being used for medical or nonmedical purposes, especially in people and patients who do not have experience with cannabis, a group that is at high risk for experiencing anxiety after using cannabis.”
In addition, “an important aspect to this study is that the effects of limonene in reducing anxiety attributed to delta-9-THC were observed at higher concentrations (or doses) than those usually present in the plant,” Dr. Copper said. “This calls for further investigation into new cannabis formulations specifically designed to leverage the potential protective effects of the terpene.”
This research was supported by the National Institute on Drug Abuse. Dr. Vandrey served as a consultant or received honoraria from Mira1a Therapeutics, Inc.; Jazz Pharmaceuticals; Charlotte’s Web; Syqe Medical Ltd.; and WebMD. The other authors’ disclosures are listed on the original paper. Dr. Lile declared no relevant financial relationships. Dr. Cooper reported receiving study drug from Canopy Growth Corp and True Terpenes, study-related materials from Storz & Bickel, and research support from the National Institute on Drug Abuse, National Center for Complementary and Integrative Health, California Department of Cannabis Control, Center for Medicinal Cannabis Research, and California Highway Patrol.
A version of this article appeared on Medscape.com.
, new data from a small study suggested.
Participants who inhaled vaporized D-limonene and THC reported significantly greater decreases in anxiogenic effects than did people who received either component alone or a placebo. Reductions were greater as the dose of the D-limonene was increased.
Investigators noted that the findings could have implications for the use of medicinal or recreational cannabis, which has increased in recent years due to state legalization efforts.
“People use cannabis to help reduce anxiety, depression, and posttraumatic stress disorder, but since THC levels vary widely, if a person overshoots their tolerance of THC, cannabis can induce anxiety rather than relieve it,” senior investigator Ryan Vandrey, PhD, professor of psychiatry and behavioral sciences, Johns Hopkins School of Medicine, Baltimore, said in a news release.
“Our study demonstrates that D-limonene can modulate the effects of THC in a meaningful way and make THC more tolerable to people using it for both therapeutic and non-therapeutic purposes,” he added.
The study was published online in Drug and Alcohol Dependence.
Entourage Theory
Cannabis legalization has opened the door to an increased range of medicinal and nonmedicinal uses, but its benefits can be limited by the anxiety and panic some people experience with its use, investigators noted.
Many cannabis plants have been bred to contain higher concentrations of THC, with some dispensaries selling cannabis with more than 20%-30% THC. The plants often include cannabidiol, “minor” cannabinoids, and terpenes, such as D-limonene.
Prior studies pointed to THC as the cause of acute behavioral and psychoactive effects some cannabis users experience. However, a new, untested theory, the “cannabis entourage effect theory,” suggested other components in cannabis, including D-limonene, may contribute to the anxiogenic symptoms.
“We were motivated by scientific publications that hypothesized D-limonene can attenuate the acute anxiogenic effects of cannabis, but for which empirical data did not exist,” Dr. Vandrey said.
Investigators designed a small double-blind, within-subjects crossover study of 20 healthy adults (median age, 26 years; 50% men). About half of participants were Caucasian/non-Hispanic, 30% African American/non-Hispanic, 10% Caucasian/Hispanic, and 10% Asian/non-Hispanic.
All participants completed nine outpatient drug administration sessions, during which they inhaled vaporized D-limonene alone (1 or 5 mg), THC alone (15 or 30 mg), the same doses of THC and D-limonene together, or placebo.
Primary outcomes included subjective drug effects, measured with the Drug Effect Questionnaire (DEQ) and the 20-item state subscale of the State-Trait Anxiety Inventory (STAI-S). Investigators also measured cognitive/psychomotor performance with the Digit Symbol Substitution Task (DSST) and the Paced Serial Addition Task.
Vital signs such as heart rate, systolic blood pressure (SBP), diastolic blood pressure (DBP), and plasma D-limonene and THC concentrations were also tracked.
Participants’ responses were measured at baseline and then an additional nine times after initial exposure over the course of each 6-hour test session. Blood and urine samples were collected from participants before, during, and after each session.
First Evidence
There were no significant differences in outcomes between the D-limonene alone and placebo groups.
Receipt of 15- and 30-mg doses of THC alone was associated with subjective reports of acute cannabis exposure, including cognitive and physiological effects.
A treatment effect was observed for “anxious/nervous” (P < .01), “paranoid” (P < .01), and “heart racing” (P < .0001).
In planned comparisons, ratings of anxiety-like subjective effects qualitatively decreased as D-limonene dose increased, and concurrent administration of 30-mg THC plus 15-mg D-limonene significantly reduced ratings of “anxious/nervous” and “paranoid” on the DEQ compared to 30 mg of THC alone (P < .05).
Findings were similar on the composite score of the STAI-S, and although planned comparisons did not reach the threshold for statistical significance, reductions in anxiety approached significance in the THC plus D-limonene group compared with the THC alone condition (P = .08). The combination group also reported significantly lower subjective ratings of unpleasant drug effects than the THC alone group (P = .03).
In particular, a main effect of treatment was found for the anxious/nervous category on the DEQ (P < .01), as well as the “paranoid” (P < .01) and heart racing (P < .0001) categories.
On the other hand, ratings of anxious/nervous and paranoid categories were significantly lower in the 30-mg THC plus 15-mg D-limonene vs the 30-mg THC alone condition (P < .05, for all).
As for cognition, following drug administration, a significant main effect of treatment was observed for the DSST (P < .05), but no significant differences between THC and THC plus D-limonene combination conditions or between D-limonene alone and placebo were detected.
There were no differences within each THC dose and between D-limonene alone versus placebo conditions. Moreover, there were no main effects of treatment found for SBP or DBP.
The combination condition produced significantly greater concentrations of THC than the THC alone condition (P < .05).
“This study provides the first evidence that there are chemical constituents found naturally in the cannabis plant that can reduce some of the adverse effects of using delta-9-THC,” Dr. Vandrey said.
Although the exact mechanism by which vaporized D-limonene counters the anxiogenic effects of THC is unclear, “our best guess is that D-limonene is producing an anxiolytic effect on its own that is not mediated by cannabinoid receptors,” Dr. Vandrey said.
Significant Impact
Commenting on the research, Joshua Lile, PhD, professor, Department of Behavioral Science, University of Kentucky College of Medicine, Lexington, noted that the study seems to be the first of its kind to study the influence of terpene on THC response.
The research “makes a significant impact on our field,” and is “among the few controlled clinical studies that have demonstrated interactions between THC and other cannabis constituents, supporting the validity of the ‘entourage’ effect,” said Dr. Lile, who was not involved with the current research.
“This work is particularly important, given the unfounded claims sometimes made by the cannabis industry regarding the effects of different cannabis products,” he added.
Also commenting on the study, Ziva Cooper, PhD, professor and director of the UCLA Center for Cannabis and Cannabinoids, University of California Los Angeles, said the findings “have direct implications for improving the safety of cannabis, whether it’s being used for medical or nonmedical purposes, especially in people and patients who do not have experience with cannabis, a group that is at high risk for experiencing anxiety after using cannabis.”
In addition, “an important aspect to this study is that the effects of limonene in reducing anxiety attributed to delta-9-THC were observed at higher concentrations (or doses) than those usually present in the plant,” Dr. Copper said. “This calls for further investigation into new cannabis formulations specifically designed to leverage the potential protective effects of the terpene.”
This research was supported by the National Institute on Drug Abuse. Dr. Vandrey served as a consultant or received honoraria from Mira1a Therapeutics, Inc.; Jazz Pharmaceuticals; Charlotte’s Web; Syqe Medical Ltd.; and WebMD. The other authors’ disclosures are listed on the original paper. Dr. Lile declared no relevant financial relationships. Dr. Cooper reported receiving study drug from Canopy Growth Corp and True Terpenes, study-related materials from Storz & Bickel, and research support from the National Institute on Drug Abuse, National Center for Complementary and Integrative Health, California Department of Cannabis Control, Center for Medicinal Cannabis Research, and California Highway Patrol.
A version of this article appeared on Medscape.com.
, new data from a small study suggested.
Participants who inhaled vaporized D-limonene and THC reported significantly greater decreases in anxiogenic effects than did people who received either component alone or a placebo. Reductions were greater as the dose of the D-limonene was increased.
Investigators noted that the findings could have implications for the use of medicinal or recreational cannabis, which has increased in recent years due to state legalization efforts.
“People use cannabis to help reduce anxiety, depression, and posttraumatic stress disorder, but since THC levels vary widely, if a person overshoots their tolerance of THC, cannabis can induce anxiety rather than relieve it,” senior investigator Ryan Vandrey, PhD, professor of psychiatry and behavioral sciences, Johns Hopkins School of Medicine, Baltimore, said in a news release.
“Our study demonstrates that D-limonene can modulate the effects of THC in a meaningful way and make THC more tolerable to people using it for both therapeutic and non-therapeutic purposes,” he added.
The study was published online in Drug and Alcohol Dependence.
Entourage Theory
Cannabis legalization has opened the door to an increased range of medicinal and nonmedicinal uses, but its benefits can be limited by the anxiety and panic some people experience with its use, investigators noted.
Many cannabis plants have been bred to contain higher concentrations of THC, with some dispensaries selling cannabis with more than 20%-30% THC. The plants often include cannabidiol, “minor” cannabinoids, and terpenes, such as D-limonene.
Prior studies pointed to THC as the cause of acute behavioral and psychoactive effects some cannabis users experience. However, a new, untested theory, the “cannabis entourage effect theory,” suggested other components in cannabis, including D-limonene, may contribute to the anxiogenic symptoms.
“We were motivated by scientific publications that hypothesized D-limonene can attenuate the acute anxiogenic effects of cannabis, but for which empirical data did not exist,” Dr. Vandrey said.
Investigators designed a small double-blind, within-subjects crossover study of 20 healthy adults (median age, 26 years; 50% men). About half of participants were Caucasian/non-Hispanic, 30% African American/non-Hispanic, 10% Caucasian/Hispanic, and 10% Asian/non-Hispanic.
All participants completed nine outpatient drug administration sessions, during which they inhaled vaporized D-limonene alone (1 or 5 mg), THC alone (15 or 30 mg), the same doses of THC and D-limonene together, or placebo.
Primary outcomes included subjective drug effects, measured with the Drug Effect Questionnaire (DEQ) and the 20-item state subscale of the State-Trait Anxiety Inventory (STAI-S). Investigators also measured cognitive/psychomotor performance with the Digit Symbol Substitution Task (DSST) and the Paced Serial Addition Task.
Vital signs such as heart rate, systolic blood pressure (SBP), diastolic blood pressure (DBP), and plasma D-limonene and THC concentrations were also tracked.
Participants’ responses were measured at baseline and then an additional nine times after initial exposure over the course of each 6-hour test session. Blood and urine samples were collected from participants before, during, and after each session.
First Evidence
There were no significant differences in outcomes between the D-limonene alone and placebo groups.
Receipt of 15- and 30-mg doses of THC alone was associated with subjective reports of acute cannabis exposure, including cognitive and physiological effects.
A treatment effect was observed for “anxious/nervous” (P < .01), “paranoid” (P < .01), and “heart racing” (P < .0001).
In planned comparisons, ratings of anxiety-like subjective effects qualitatively decreased as D-limonene dose increased, and concurrent administration of 30-mg THC plus 15-mg D-limonene significantly reduced ratings of “anxious/nervous” and “paranoid” on the DEQ compared to 30 mg of THC alone (P < .05).
Findings were similar on the composite score of the STAI-S, and although planned comparisons did not reach the threshold for statistical significance, reductions in anxiety approached significance in the THC plus D-limonene group compared with the THC alone condition (P = .08). The combination group also reported significantly lower subjective ratings of unpleasant drug effects than the THC alone group (P = .03).
In particular, a main effect of treatment was found for the anxious/nervous category on the DEQ (P < .01), as well as the “paranoid” (P < .01) and heart racing (P < .0001) categories.
On the other hand, ratings of anxious/nervous and paranoid categories were significantly lower in the 30-mg THC plus 15-mg D-limonene vs the 30-mg THC alone condition (P < .05, for all).
As for cognition, following drug administration, a significant main effect of treatment was observed for the DSST (P < .05), but no significant differences between THC and THC plus D-limonene combination conditions or between D-limonene alone and placebo were detected.
There were no differences within each THC dose and between D-limonene alone versus placebo conditions. Moreover, there were no main effects of treatment found for SBP or DBP.
The combination condition produced significantly greater concentrations of THC than the THC alone condition (P < .05).
“This study provides the first evidence that there are chemical constituents found naturally in the cannabis plant that can reduce some of the adverse effects of using delta-9-THC,” Dr. Vandrey said.
Although the exact mechanism by which vaporized D-limonene counters the anxiogenic effects of THC is unclear, “our best guess is that D-limonene is producing an anxiolytic effect on its own that is not mediated by cannabinoid receptors,” Dr. Vandrey said.
Significant Impact
Commenting on the research, Joshua Lile, PhD, professor, Department of Behavioral Science, University of Kentucky College of Medicine, Lexington, noted that the study seems to be the first of its kind to study the influence of terpene on THC response.
The research “makes a significant impact on our field,” and is “among the few controlled clinical studies that have demonstrated interactions between THC and other cannabis constituents, supporting the validity of the ‘entourage’ effect,” said Dr. Lile, who was not involved with the current research.
“This work is particularly important, given the unfounded claims sometimes made by the cannabis industry regarding the effects of different cannabis products,” he added.
Also commenting on the study, Ziva Cooper, PhD, professor and director of the UCLA Center for Cannabis and Cannabinoids, University of California Los Angeles, said the findings “have direct implications for improving the safety of cannabis, whether it’s being used for medical or nonmedical purposes, especially in people and patients who do not have experience with cannabis, a group that is at high risk for experiencing anxiety after using cannabis.”
In addition, “an important aspect to this study is that the effects of limonene in reducing anxiety attributed to delta-9-THC were observed at higher concentrations (or doses) than those usually present in the plant,” Dr. Copper said. “This calls for further investigation into new cannabis formulations specifically designed to leverage the potential protective effects of the terpene.”
This research was supported by the National Institute on Drug Abuse. Dr. Vandrey served as a consultant or received honoraria from Mira1a Therapeutics, Inc.; Jazz Pharmaceuticals; Charlotte’s Web; Syqe Medical Ltd.; and WebMD. The other authors’ disclosures are listed on the original paper. Dr. Lile declared no relevant financial relationships. Dr. Cooper reported receiving study drug from Canopy Growth Corp and True Terpenes, study-related materials from Storz & Bickel, and research support from the National Institute on Drug Abuse, National Center for Complementary and Integrative Health, California Department of Cannabis Control, Center for Medicinal Cannabis Research, and California Highway Patrol.
A version of this article appeared on Medscape.com.
From Drug and Alcohol Dependence
‘Difficult Patient’: Stigmatizing Words and Medical Error
This transcript has been edited for clarity.
When I was doing my nephrology training, I had an attending who would write notes that were, well, kind of funny. I remember one time we were seeing a patient whose first name was “Lucky.” He dryly opened his section of the consult note as follows: “This is a 56-year-old woman with an ironic name who presents with acute renal failure.”
As an exhausted renal fellow, I appreciated the bit of color amid the ongoing series of tragedies that was the consult service. But let’s be clear — writing like this in the medical record is not a good idea. It wasn’t a good idea then, when any record might end up disclosed during a malpractice suit, and it’s really not a good idea now, when patients have ready and automated access to all the notes we write about them.
And yet, worse language than that of my attending appears in hospital notes all the time; there is research about this. Specifically, I’m talking about language that does not have high clinical utility but telegraphs the biases of the person writing the note. This is known as “stigmatizing language” and it can be overt or subtle.
For example, a physician wrote “I listed several fictitious medication names and she reported she was taking them.”
This casts suspicions about the patient’s credibility, as does the more subtle statement, “he claims nicotine patches don’t work for him.” Stigmatizing language may cast the patient in a difficult light, like this note: “she persevered on the fact that ... ‘you wouldn’t understand.’ ”
Stay with me.
We are going to start by defining a very sick patient population: those admitted to the hospital and who, within 48 hours, have either been transferred to the intensive care unit or died. Because of the severity of illness in this population we’ve just defined, figuring out whether a diagnostic or other error was made would be extremely high yield; these can mean the difference between life and death.
In a letter appearing in JAMA Internal Medicine, researchers examined a group of more than 2300 patients just like this from 29 hospitals, scouring the medical records for evidence of these types of errors.
Nearly one in four (23.2%) had at least one diagnostic error, which could include a missed physical exam finding, failure to ask a key question on history taking, inadequate testing, and so on.
Understanding why we make these errors is clearly critical to improving care for these patients. The researchers hypothesized that stigmatizing language might lead to errors like this. For example, by demonstrating that you don’t find a patient credible, you may ignore statements that would help make a better diagnosis.
Just over 5% of these patients had evidence of stigmatizing language in their medical notes. Like earlier studies, this language was more common if the patient was Black or had unstable housing.
Critically, stigmatizing language was more likely to be found among those who had diagnostic errors — a rate of 8.2% vs 4.1%. After adjustment for factors like race, the presence of stigmatizing language was associated with roughly a doubling of the risk for diagnostic errors.
Now, I’m all for eliminating stigmatizing language from our medical notes. And, given the increased transparency of all medical notes these days, I expect that we’ll see less of this over time. But of course, the fact that a physician doesn’t write something that disparages the patient does not necessarily mean that they don’t retain that bias. That said, those comments have an effect on all the other team members who care for that patient as well; it sets a tone and can entrench an individual’s bias more broadly. We should strive to eliminate our biases when it comes to caring for patients. But perhaps the second best thing is to work to keep those biases to ourselves.
Dr. Wilson is associate professor of medicine and public health and director of the Clinical and Translational Research Accelerator at Yale University, New Haven, Conn. He has disclosed no relevant financial relationships.
A version of this article appeared on Medscape.com.
This transcript has been edited for clarity.
When I was doing my nephrology training, I had an attending who would write notes that were, well, kind of funny. I remember one time we were seeing a patient whose first name was “Lucky.” He dryly opened his section of the consult note as follows: “This is a 56-year-old woman with an ironic name who presents with acute renal failure.”
As an exhausted renal fellow, I appreciated the bit of color amid the ongoing series of tragedies that was the consult service. But let’s be clear — writing like this in the medical record is not a good idea. It wasn’t a good idea then, when any record might end up disclosed during a malpractice suit, and it’s really not a good idea now, when patients have ready and automated access to all the notes we write about them.
And yet, worse language than that of my attending appears in hospital notes all the time; there is research about this. Specifically, I’m talking about language that does not have high clinical utility but telegraphs the biases of the person writing the note. This is known as “stigmatizing language” and it can be overt or subtle.
For example, a physician wrote “I listed several fictitious medication names and she reported she was taking them.”
This casts suspicions about the patient’s credibility, as does the more subtle statement, “he claims nicotine patches don’t work for him.” Stigmatizing language may cast the patient in a difficult light, like this note: “she persevered on the fact that ... ‘you wouldn’t understand.’ ”
Stay with me.
We are going to start by defining a very sick patient population: those admitted to the hospital and who, within 48 hours, have either been transferred to the intensive care unit or died. Because of the severity of illness in this population we’ve just defined, figuring out whether a diagnostic or other error was made would be extremely high yield; these can mean the difference between life and death.
In a letter appearing in JAMA Internal Medicine, researchers examined a group of more than 2300 patients just like this from 29 hospitals, scouring the medical records for evidence of these types of errors.
Nearly one in four (23.2%) had at least one diagnostic error, which could include a missed physical exam finding, failure to ask a key question on history taking, inadequate testing, and so on.
Understanding why we make these errors is clearly critical to improving care for these patients. The researchers hypothesized that stigmatizing language might lead to errors like this. For example, by demonstrating that you don’t find a patient credible, you may ignore statements that would help make a better diagnosis.
Just over 5% of these patients had evidence of stigmatizing language in their medical notes. Like earlier studies, this language was more common if the patient was Black or had unstable housing.
Critically, stigmatizing language was more likely to be found among those who had diagnostic errors — a rate of 8.2% vs 4.1%. After adjustment for factors like race, the presence of stigmatizing language was associated with roughly a doubling of the risk for diagnostic errors.
Now, I’m all for eliminating stigmatizing language from our medical notes. And, given the increased transparency of all medical notes these days, I expect that we’ll see less of this over time. But of course, the fact that a physician doesn’t write something that disparages the patient does not necessarily mean that they don’t retain that bias. That said, those comments have an effect on all the other team members who care for that patient as well; it sets a tone and can entrench an individual’s bias more broadly. We should strive to eliminate our biases when it comes to caring for patients. But perhaps the second best thing is to work to keep those biases to ourselves.
Dr. Wilson is associate professor of medicine and public health and director of the Clinical and Translational Research Accelerator at Yale University, New Haven, Conn. He has disclosed no relevant financial relationships.
A version of this article appeared on Medscape.com.
This transcript has been edited for clarity.
When I was doing my nephrology training, I had an attending who would write notes that were, well, kind of funny. I remember one time we were seeing a patient whose first name was “Lucky.” He dryly opened his section of the consult note as follows: “This is a 56-year-old woman with an ironic name who presents with acute renal failure.”
As an exhausted renal fellow, I appreciated the bit of color amid the ongoing series of tragedies that was the consult service. But let’s be clear — writing like this in the medical record is not a good idea. It wasn’t a good idea then, when any record might end up disclosed during a malpractice suit, and it’s really not a good idea now, when patients have ready and automated access to all the notes we write about them.
And yet, worse language than that of my attending appears in hospital notes all the time; there is research about this. Specifically, I’m talking about language that does not have high clinical utility but telegraphs the biases of the person writing the note. This is known as “stigmatizing language” and it can be overt or subtle.
For example, a physician wrote “I listed several fictitious medication names and she reported she was taking them.”
This casts suspicions about the patient’s credibility, as does the more subtle statement, “he claims nicotine patches don’t work for him.” Stigmatizing language may cast the patient in a difficult light, like this note: “she persevered on the fact that ... ‘you wouldn’t understand.’ ”
Stay with me.
We are going to start by defining a very sick patient population: those admitted to the hospital and who, within 48 hours, have either been transferred to the intensive care unit or died. Because of the severity of illness in this population we’ve just defined, figuring out whether a diagnostic or other error was made would be extremely high yield; these can mean the difference between life and death.
In a letter appearing in JAMA Internal Medicine, researchers examined a group of more than 2300 patients just like this from 29 hospitals, scouring the medical records for evidence of these types of errors.
Nearly one in four (23.2%) had at least one diagnostic error, which could include a missed physical exam finding, failure to ask a key question on history taking, inadequate testing, and so on.
Understanding why we make these errors is clearly critical to improving care for these patients. The researchers hypothesized that stigmatizing language might lead to errors like this. For example, by demonstrating that you don’t find a patient credible, you may ignore statements that would help make a better diagnosis.
Just over 5% of these patients had evidence of stigmatizing language in their medical notes. Like earlier studies, this language was more common if the patient was Black or had unstable housing.
Critically, stigmatizing language was more likely to be found among those who had diagnostic errors — a rate of 8.2% vs 4.1%. After adjustment for factors like race, the presence of stigmatizing language was associated with roughly a doubling of the risk for diagnostic errors.
Now, I’m all for eliminating stigmatizing language from our medical notes. And, given the increased transparency of all medical notes these days, I expect that we’ll see less of this over time. But of course, the fact that a physician doesn’t write something that disparages the patient does not necessarily mean that they don’t retain that bias. That said, those comments have an effect on all the other team members who care for that patient as well; it sets a tone and can entrench an individual’s bias more broadly. We should strive to eliminate our biases when it comes to caring for patients. But perhaps the second best thing is to work to keep those biases to ourselves.
Dr. Wilson is associate professor of medicine and public health and director of the Clinical and Translational Research Accelerator at Yale University, New Haven, Conn. He has disclosed no relevant financial relationships.
A version of this article appeared on Medscape.com.