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Proclivity ID
18813001
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Specialty Focus
Psoriatic Arthritis
Spondyloarthropathies
Rheumatoid Arthritis
Osteoarthritis
Negative Keywords
gaming
gambling
compulsive behaviors
ammunition
assault rifle
black jack
Boko Haram
bondage
child abuse
cocaine
Daech
drug paraphernalia
explosion
gun
human trafficking
ISIL
ISIS
Islamic caliphate
Islamic state
mixed martial arts
MMA
molestation
national rifle association
NRA
nsfw
pedophile
pedophilia
poker
porn
pornography
psychedelic drug
recreational drug
sex slave rings
slot machine
terrorism
terrorist
Texas hold 'em
UFC
substance abuse
abuseed
abuseer
abusees
abuseing
abusely
abuses
aeolus
aeolused
aeoluser
aeoluses
aeolusing
aeolusly
aeoluss
ahole
aholeed
aholeer
aholees
aholeing
aholely
aholes
alcohol
alcoholed
alcoholer
alcoholes
alcoholing
alcoholly
alcohols
allman
allmaned
allmaner
allmanes
allmaning
allmanly
allmans
alted
altes
alting
altly
alts
analed
analer
anales
analing
anally
analprobe
analprobeed
analprobeer
analprobees
analprobeing
analprobely
analprobes
anals
anilingus
anilingused
anilinguser
anilinguses
anilingusing
anilingusly
anilinguss
anus
anused
anuser
anuses
anusing
anusly
anuss
areola
areolaed
areolaer
areolaes
areolaing
areolaly
areolas
areole
areoleed
areoleer
areolees
areoleing
areolely
areoles
arian
arianed
arianer
arianes
arianing
arianly
arians
aryan
aryaned
aryaner
aryanes
aryaning
aryanly
aryans
asiaed
asiaer
asiaes
asiaing
asialy
asias
ass
ass hole
ass lick
ass licked
ass licker
ass lickes
ass licking
ass lickly
ass licks
assbang
assbanged
assbangeded
assbangeder
assbangedes
assbangeding
assbangedly
assbangeds
assbanger
assbanges
assbanging
assbangly
assbangs
assbangsed
assbangser
assbangses
assbangsing
assbangsly
assbangss
assed
asser
asses
assesed
asseser
asseses
assesing
assesly
assess
assfuck
assfucked
assfucker
assfuckered
assfuckerer
assfuckeres
assfuckering
assfuckerly
assfuckers
assfuckes
assfucking
assfuckly
assfucks
asshat
asshated
asshater
asshates
asshating
asshatly
asshats
assholeed
assholeer
assholees
assholeing
assholely
assholes
assholesed
assholeser
assholeses
assholesing
assholesly
assholess
assing
assly
assmaster
assmastered
assmasterer
assmasteres
assmastering
assmasterly
assmasters
assmunch
assmunched
assmuncher
assmunches
assmunching
assmunchly
assmunchs
asss
asswipe
asswipeed
asswipeer
asswipees
asswipeing
asswipely
asswipes
asswipesed
asswipeser
asswipeses
asswipesing
asswipesly
asswipess
azz
azzed
azzer
azzes
azzing
azzly
azzs
babeed
babeer
babees
babeing
babely
babes
babesed
babeser
babeses
babesing
babesly
babess
ballsac
ballsaced
ballsacer
ballsaces
ballsacing
ballsack
ballsacked
ballsacker
ballsackes
ballsacking
ballsackly
ballsacks
ballsacly
ballsacs
ballsed
ballser
ballses
ballsing
ballsly
ballss
barf
barfed
barfer
barfes
barfing
barfly
barfs
bastard
bastarded
bastarder
bastardes
bastarding
bastardly
bastards
bastardsed
bastardser
bastardses
bastardsing
bastardsly
bastardss
bawdy
bawdyed
bawdyer
bawdyes
bawdying
bawdyly
bawdys
beaner
beanered
beanerer
beaneres
beanering
beanerly
beaners
beardedclam
beardedclamed
beardedclamer
beardedclames
beardedclaming
beardedclamly
beardedclams
beastiality
beastialityed
beastialityer
beastialityes
beastialitying
beastialityly
beastialitys
beatch
beatched
beatcher
beatches
beatching
beatchly
beatchs
beater
beatered
beaterer
beateres
beatering
beaterly
beaters
beered
beerer
beeres
beering
beerly
beeyotch
beeyotched
beeyotcher
beeyotches
beeyotching
beeyotchly
beeyotchs
beotch
beotched
beotcher
beotches
beotching
beotchly
beotchs
biatch
biatched
biatcher
biatches
biatching
biatchly
biatchs
big tits
big titsed
big titser
big titses
big titsing
big titsly
big titss
bigtits
bigtitsed
bigtitser
bigtitses
bigtitsing
bigtitsly
bigtitss
bimbo
bimboed
bimboer
bimboes
bimboing
bimboly
bimbos
bisexualed
bisexualer
bisexuales
bisexualing
bisexually
bisexuals
bitch
bitched
bitcheded
bitcheder
bitchedes
bitcheding
bitchedly
bitcheds
bitcher
bitches
bitchesed
bitcheser
bitcheses
bitchesing
bitchesly
bitchess
bitching
bitchly
bitchs
bitchy
bitchyed
bitchyer
bitchyes
bitchying
bitchyly
bitchys
bleached
bleacher
bleaches
bleaching
bleachly
bleachs
blow job
blow jobed
blow jober
blow jobes
blow jobing
blow jobly
blow jobs
blowed
blower
blowes
blowing
blowjob
blowjobed
blowjober
blowjobes
blowjobing
blowjobly
blowjobs
blowjobsed
blowjobser
blowjobses
blowjobsing
blowjobsly
blowjobss
blowly
blows
boink
boinked
boinker
boinkes
boinking
boinkly
boinks
bollock
bollocked
bollocker
bollockes
bollocking
bollockly
bollocks
bollocksed
bollockser
bollockses
bollocksing
bollocksly
bollockss
bollok
bolloked
bolloker
bollokes
bolloking
bollokly
bolloks
boner
bonered
bonerer
boneres
bonering
bonerly
boners
bonersed
bonerser
bonerses
bonersing
bonersly
bonerss
bong
bonged
bonger
bonges
bonging
bongly
bongs
boob
boobed
boober
boobes
boobies
boobiesed
boobieser
boobieses
boobiesing
boobiesly
boobiess
boobing
boobly
boobs
boobsed
boobser
boobses
boobsing
boobsly
boobss
booby
boobyed
boobyer
boobyes
boobying
boobyly
boobys
booger
boogered
boogerer
boogeres
boogering
boogerly
boogers
bookie
bookieed
bookieer
bookiees
bookieing
bookiely
bookies
bootee
booteeed
booteeer
booteees
booteeing
booteely
bootees
bootie
bootieed
bootieer
bootiees
bootieing
bootiely
booties
booty
bootyed
bootyer
bootyes
bootying
bootyly
bootys
boozeed
boozeer
boozees
boozeing
boozely
boozer
boozered
boozerer
boozeres
boozering
boozerly
boozers
boozes
boozy
boozyed
boozyer
boozyes
boozying
boozyly
boozys
bosomed
bosomer
bosomes
bosoming
bosomly
bosoms
bosomy
bosomyed
bosomyer
bosomyes
bosomying
bosomyly
bosomys
bugger
buggered
buggerer
buggeres
buggering
buggerly
buggers
bukkake
bukkakeed
bukkakeer
bukkakees
bukkakeing
bukkakely
bukkakes
bull shit
bull shited
bull shiter
bull shites
bull shiting
bull shitly
bull shits
bullshit
bullshited
bullshiter
bullshites
bullshiting
bullshitly
bullshits
bullshitsed
bullshitser
bullshitses
bullshitsing
bullshitsly
bullshitss
bullshitted
bullshitteded
bullshitteder
bullshittedes
bullshitteding
bullshittedly
bullshitteds
bullturds
bullturdsed
bullturdser
bullturdses
bullturdsing
bullturdsly
bullturdss
bung
bunged
bunger
bunges
bunging
bungly
bungs
busty
bustyed
bustyer
bustyes
bustying
bustyly
bustys
butt
butt fuck
butt fucked
butt fucker
butt fuckes
butt fucking
butt fuckly
butt fucks
butted
buttes
buttfuck
buttfucked
buttfucker
buttfuckered
buttfuckerer
buttfuckeres
buttfuckering
buttfuckerly
buttfuckers
buttfuckes
buttfucking
buttfuckly
buttfucks
butting
buttly
buttplug
buttpluged
buttpluger
buttpluges
buttpluging
buttplugly
buttplugs
butts
caca
cacaed
cacaer
cacaes
cacaing
cacaly
cacas
cahone
cahoneed
cahoneer
cahonees
cahoneing
cahonely
cahones
cameltoe
cameltoeed
cameltoeer
cameltoees
cameltoeing
cameltoely
cameltoes
carpetmuncher
carpetmunchered
carpetmuncherer
carpetmuncheres
carpetmunchering
carpetmuncherly
carpetmunchers
cawk
cawked
cawker
cawkes
cawking
cawkly
cawks
chinc
chinced
chincer
chinces
chincing
chincly
chincs
chincsed
chincser
chincses
chincsing
chincsly
chincss
chink
chinked
chinker
chinkes
chinking
chinkly
chinks
chode
chodeed
chodeer
chodees
chodeing
chodely
chodes
chodesed
chodeser
chodeses
chodesing
chodesly
chodess
clit
clited
cliter
clites
cliting
clitly
clitoris
clitorised
clitoriser
clitorises
clitorising
clitorisly
clitoriss
clitorus
clitorused
clitoruser
clitoruses
clitorusing
clitorusly
clitoruss
clits
clitsed
clitser
clitses
clitsing
clitsly
clitss
clitty
clittyed
clittyer
clittyes
clittying
clittyly
clittys
cocain
cocaine
cocained
cocaineed
cocaineer
cocainees
cocaineing
cocainely
cocainer
cocaines
cocaining
cocainly
cocains
cock
cock sucker
cock suckered
cock suckerer
cock suckeres
cock suckering
cock suckerly
cock suckers
cockblock
cockblocked
cockblocker
cockblockes
cockblocking
cockblockly
cockblocks
cocked
cocker
cockes
cockholster
cockholstered
cockholsterer
cockholsteres
cockholstering
cockholsterly
cockholsters
cocking
cockknocker
cockknockered
cockknockerer
cockknockeres
cockknockering
cockknockerly
cockknockers
cockly
cocks
cocksed
cockser
cockses
cocksing
cocksly
cocksmoker
cocksmokered
cocksmokerer
cocksmokeres
cocksmokering
cocksmokerly
cocksmokers
cockss
cocksucker
cocksuckered
cocksuckerer
cocksuckeres
cocksuckering
cocksuckerly
cocksuckers
coital
coitaled
coitaler
coitales
coitaling
coitally
coitals
commie
commieed
commieer
commiees
commieing
commiely
commies
condomed
condomer
condomes
condoming
condomly
condoms
coon
cooned
cooner
coones
cooning
coonly
coons
coonsed
coonser
coonses
coonsing
coonsly
coonss
corksucker
corksuckered
corksuckerer
corksuckeres
corksuckering
corksuckerly
corksuckers
cracked
crackwhore
crackwhoreed
crackwhoreer
crackwhorees
crackwhoreing
crackwhorely
crackwhores
crap
craped
craper
crapes
craping
craply
crappy
crappyed
crappyer
crappyes
crappying
crappyly
crappys
cum
cumed
cumer
cumes
cuming
cumly
cummin
cummined
cumminer
cummines
cumming
cumminged
cumminger
cumminges
cumminging
cummingly
cummings
cummining
cumminly
cummins
cums
cumshot
cumshoted
cumshoter
cumshotes
cumshoting
cumshotly
cumshots
cumshotsed
cumshotser
cumshotses
cumshotsing
cumshotsly
cumshotss
cumslut
cumsluted
cumsluter
cumslutes
cumsluting
cumslutly
cumsluts
cumstain
cumstained
cumstainer
cumstaines
cumstaining
cumstainly
cumstains
cunilingus
cunilingused
cunilinguser
cunilinguses
cunilingusing
cunilingusly
cunilinguss
cunnilingus
cunnilingused
cunnilinguser
cunnilinguses
cunnilingusing
cunnilingusly
cunnilinguss
cunny
cunnyed
cunnyer
cunnyes
cunnying
cunnyly
cunnys
cunt
cunted
cunter
cuntes
cuntface
cuntfaceed
cuntfaceer
cuntfacees
cuntfaceing
cuntfacely
cuntfaces
cunthunter
cunthuntered
cunthunterer
cunthunteres
cunthuntering
cunthunterly
cunthunters
cunting
cuntlick
cuntlicked
cuntlicker
cuntlickered
cuntlickerer
cuntlickeres
cuntlickering
cuntlickerly
cuntlickers
cuntlickes
cuntlicking
cuntlickly
cuntlicks
cuntly
cunts
cuntsed
cuntser
cuntses
cuntsing
cuntsly
cuntss
dago
dagoed
dagoer
dagoes
dagoing
dagoly
dagos
dagosed
dagoser
dagoses
dagosing
dagosly
dagoss
dammit
dammited
dammiter
dammites
dammiting
dammitly
dammits
damn
damned
damneded
damneder
damnedes
damneding
damnedly
damneds
damner
damnes
damning
damnit
damnited
damniter
damnites
damniting
damnitly
damnits
damnly
damns
dick
dickbag
dickbaged
dickbager
dickbages
dickbaging
dickbagly
dickbags
dickdipper
dickdippered
dickdipperer
dickdipperes
dickdippering
dickdipperly
dickdippers
dicked
dicker
dickes
dickface
dickfaceed
dickfaceer
dickfacees
dickfaceing
dickfacely
dickfaces
dickflipper
dickflippered
dickflipperer
dickflipperes
dickflippering
dickflipperly
dickflippers
dickhead
dickheaded
dickheader
dickheades
dickheading
dickheadly
dickheads
dickheadsed
dickheadser
dickheadses
dickheadsing
dickheadsly
dickheadss
dicking
dickish
dickished
dickisher
dickishes
dickishing
dickishly
dickishs
dickly
dickripper
dickrippered
dickripperer
dickripperes
dickrippering
dickripperly
dickrippers
dicks
dicksipper
dicksippered
dicksipperer
dicksipperes
dicksippering
dicksipperly
dicksippers
dickweed
dickweeded
dickweeder
dickweedes
dickweeding
dickweedly
dickweeds
dickwhipper
dickwhippered
dickwhipperer
dickwhipperes
dickwhippering
dickwhipperly
dickwhippers
dickzipper
dickzippered
dickzipperer
dickzipperes
dickzippering
dickzipperly
dickzippers
diddle
diddleed
diddleer
diddlees
diddleing
diddlely
diddles
dike
dikeed
dikeer
dikees
dikeing
dikely
dikes
dildo
dildoed
dildoer
dildoes
dildoing
dildoly
dildos
dildosed
dildoser
dildoses
dildosing
dildosly
dildoss
diligaf
diligafed
diligafer
diligafes
diligafing
diligafly
diligafs
dillweed
dillweeded
dillweeder
dillweedes
dillweeding
dillweedly
dillweeds
dimwit
dimwited
dimwiter
dimwites
dimwiting
dimwitly
dimwits
dingle
dingleed
dingleer
dinglees
dingleing
dinglely
dingles
dipship
dipshiped
dipshiper
dipshipes
dipshiping
dipshiply
dipships
dizzyed
dizzyer
dizzyes
dizzying
dizzyly
dizzys
doggiestyleed
doggiestyleer
doggiestylees
doggiestyleing
doggiestylely
doggiestyles
doggystyleed
doggystyleer
doggystylees
doggystyleing
doggystylely
doggystyles
dong
donged
donger
donges
donging
dongly
dongs
doofus
doofused
doofuser
doofuses
doofusing
doofusly
doofuss
doosh
dooshed
doosher
dooshes
dooshing
dooshly
dooshs
dopeyed
dopeyer
dopeyes
dopeying
dopeyly
dopeys
douchebag
douchebaged
douchebager
douchebages
douchebaging
douchebagly
douchebags
douchebagsed
douchebagser
douchebagses
douchebagsing
douchebagsly
douchebagss
doucheed
doucheer
douchees
doucheing
douchely
douches
douchey
doucheyed
doucheyer
doucheyes
doucheying
doucheyly
doucheys
drunk
drunked
drunker
drunkes
drunking
drunkly
drunks
dumass
dumassed
dumasser
dumasses
dumassing
dumassly
dumasss
dumbass
dumbassed
dumbasser
dumbasses
dumbassesed
dumbasseser
dumbasseses
dumbassesing
dumbassesly
dumbassess
dumbassing
dumbassly
dumbasss
dummy
dummyed
dummyer
dummyes
dummying
dummyly
dummys
dyke
dykeed
dykeer
dykees
dykeing
dykely
dykes
dykesed
dykeser
dykeses
dykesing
dykesly
dykess
erotic
eroticed
eroticer
erotices
eroticing
eroticly
erotics
extacy
extacyed
extacyer
extacyes
extacying
extacyly
extacys
extasy
extasyed
extasyer
extasyes
extasying
extasyly
extasys
fack
facked
facker
fackes
facking
fackly
facks
fag
faged
fager
fages
fagg
fagged
faggeded
faggeder
faggedes
faggeding
faggedly
faggeds
fagger
fagges
fagging
faggit
faggited
faggiter
faggites
faggiting
faggitly
faggits
faggly
faggot
faggoted
faggoter
faggotes
faggoting
faggotly
faggots
faggs
faging
fagly
fagot
fagoted
fagoter
fagotes
fagoting
fagotly
fagots
fags
fagsed
fagser
fagses
fagsing
fagsly
fagss
faig
faiged
faiger
faiges
faiging
faigly
faigs
faigt
faigted
faigter
faigtes
faigting
faigtly
faigts
fannybandit
fannybandited
fannybanditer
fannybandites
fannybanditing
fannybanditly
fannybandits
farted
farter
fartes
farting
fartknocker
fartknockered
fartknockerer
fartknockeres
fartknockering
fartknockerly
fartknockers
fartly
farts
felch
felched
felcher
felchered
felcherer
felcheres
felchering
felcherly
felchers
felches
felching
felchinged
felchinger
felchinges
felchinging
felchingly
felchings
felchly
felchs
fellate
fellateed
fellateer
fellatees
fellateing
fellately
fellates
fellatio
fellatioed
fellatioer
fellatioes
fellatioing
fellatioly
fellatios
feltch
feltched
feltcher
feltchered
feltcherer
feltcheres
feltchering
feltcherly
feltchers
feltches
feltching
feltchly
feltchs
feom
feomed
feomer
feomes
feoming
feomly
feoms
fisted
fisteded
fisteder
fistedes
fisteding
fistedly
fisteds
fisting
fistinged
fistinger
fistinges
fistinging
fistingly
fistings
fisty
fistyed
fistyer
fistyes
fistying
fistyly
fistys
floozy
floozyed
floozyer
floozyes
floozying
floozyly
floozys
foad
foaded
foader
foades
foading
foadly
foads
fondleed
fondleer
fondlees
fondleing
fondlely
fondles
foobar
foobared
foobarer
foobares
foobaring
foobarly
foobars
freex
freexed
freexer
freexes
freexing
freexly
freexs
frigg
frigga
friggaed
friggaer
friggaes
friggaing
friggaly
friggas
frigged
frigger
frigges
frigging
friggly
friggs
fubar
fubared
fubarer
fubares
fubaring
fubarly
fubars
fuck
fuckass
fuckassed
fuckasser
fuckasses
fuckassing
fuckassly
fuckasss
fucked
fuckeded
fuckeder
fuckedes
fuckeding
fuckedly
fuckeds
fucker
fuckered
fuckerer
fuckeres
fuckering
fuckerly
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CDC emphasizes pandemic not over, need to avoid large gatherings

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In its first media briefing on coronavirus in more than 3 months, the Centers for Disease Control and Prevention (CDC) warned that the COVID-19 pandemic is not over, and large gatherings pose a high risk for COVID-19 transmission.

Robert Redfield, MD, Director, CDC, and Jay C. Butler, MD, Deputy Director of Infectious Diseases and COVID-19 Response Incident Manager, CDC, discussed two new sets of CDC guidance on deciding to go out and attending group gatherings.

“We recognize that we’re all getting tired of staying at home; people long for the life that they had back in December, and as we head into the summer months, we know that Americans will be looking forward to reconnecting with family and friends and being able to attend events, and we want that to occur as safely as possible,” Butler said.

“Our recommendations evolved based on new information that becomes available, but it continues to be extremely important that we embrace the recommendations of social distancing, handwashing, and wearing a face covering when we’re in public as some of the key defenses that we have against this virus,” Redfield explained.

“The pandemic is not over and it’s important to recognize that. While COVID-19 is still making headlines everywhere, we know the pandemic hasn’t affected everyone everywhere in the same way,” Butler said.

He noted that it is important to prepare for next fall and winter, when we can expect influenza season to complicate matters. “If anything, we must be overly-prepared for what we might face later this year,” he continued, adding that it is important to get vaccinated against influenza. “[F]lu and COVID-19 could be circulating together as we move into the fall and winter months,” he concluded.

Americans Mostly Following Guidelines

The agency also presented data from an article published online June 12 in Morbidity and Mortality Weekly Report that “underscores the fact that American people have taken mitigation efforts seriously…and it demonstrates our collective spirit in responding to the pandemic,” Butler said.

In it, the researchers describe representative panel surveys conducted among 4042 adults aged 18 years or older in New York City and Los Angeles — the two most populous cities in the United States — and “broadly across the United States” during May 5 to May 12, 2020.

Most respondents supported stay-at-home orders and nonessential business closures (United States, 79.5%; New York City, 86.7%; Los Angeles, 81.5%) and always or often wore cloth face coverings in public (United States, 74.1%; New York City, 89.6%; Los Angeles, 89.8%). Respondents also agreed that nonessential workers should remain at home (United States, 67.3%; New York City, 76.6%; Los Angeles, 69.1%), report Mark É. Czeisler, from Monash University and Austin Health, both in Melbourne, Australia, and colleagues.

There was wide support with public health guidelines: more than 87% of individuals in each area agreed that individuals should keep six feet of distance between themselves and others, and more than 82% in each area said that people should limit gatherings to fewer than 10 individuals.

At the time the survey was conducted, most were against indoor dining at restaurants (United States, 66.6%; New York City, 81.5%; Los Angeles, 71.8%).

 

 

Adherence “Widespread,” Survey Finds

Most respondents said they were adhering to COVID-19 mitigation guidance, including self-isolating (United States, 77.3%; New York City, 84.6%; Los Angeles, 83.0%) and “always or often” kept at least six feet between themselves and others (New York City, 85.7%; Los Angeles, 82.6%).

More than 85% of respondents in each of the three cohorts said they always or often avoided groups of 10 or more individuals.

About 90% of respondents said they had been in a public area during the last week, with 74.1% of those saying they always or often covered their face in public; respondents in New York City (89.6%) and Los Angeles (89.8%) had higher percentages of this behavior compared with respondents from the United States overall.

Most respondents felt that restrictions in their state were balanced or too lax (United States, 84.3%; New York City, 89.7%; Los Angeles, 79.7%) and said they would feel unsafe if restrictions were eased nationwide at that time (United States, 74.3%; New York City, 81.5%; Los Angeles, 73.4%). However, some individuals who said they would feel unsafe still wanted community mitigation strategies eased and were willing to accept risks resulting from lifting restrictions (United States, 17.1%; New York City, 12.6%; Los Angeles, 12.7%).

“Reported prevalence of self-isolation and feeling safe if community mitigation strategies were lifted differed significantly by age, employment status, and essential worker status among adults in the U.S. survey cohort,” the authors write.

Reports of self-isolation were highest among persons aged 18 to 24 years (92.3%) and lowest among those aged 45 to 54 years (71.5%). Yet, young adults aged 18 to 24 years (43.1%) were more than twice as likely to say they would feel safe if community mitigation strategies were eased, compared with adults aged 65 years or older (19.2%).

Almost half (47.2%) of employed respondents in the US cohort were essential workers; essential workers were “significantly less likely” to report self-isolating when compared with nonessential workers (63.1% vs 80.6%). Some 37.7% of essential workers said they would feel safe if community mitigation strategies were eased, compared with 23.7% of nonessential workers.

“Respondents who were male, employed, or essential workers were significantly more likely to report having been in public areas in the past week. Among respondents who had been in public areas during the preceding week, significantly higher percentages of women, adults aged ≥ 65 years, retired persons, and those living in urban areas reported wearing cloth face coverings,” the authors explain.

The findings are subject to several limitations, including self-reporting and the fact that some respondents may have known someone who tested positive for COVID-19 or died from it, the authors note. Respondents were not representative of the US population and the findings may not be generalizable.


This article first appeared on Medscape.com.

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In its first media briefing on coronavirus in more than 3 months, the Centers for Disease Control and Prevention (CDC) warned that the COVID-19 pandemic is not over, and large gatherings pose a high risk for COVID-19 transmission.

Robert Redfield, MD, Director, CDC, and Jay C. Butler, MD, Deputy Director of Infectious Diseases and COVID-19 Response Incident Manager, CDC, discussed two new sets of CDC guidance on deciding to go out and attending group gatherings.

“We recognize that we’re all getting tired of staying at home; people long for the life that they had back in December, and as we head into the summer months, we know that Americans will be looking forward to reconnecting with family and friends and being able to attend events, and we want that to occur as safely as possible,” Butler said.

“Our recommendations evolved based on new information that becomes available, but it continues to be extremely important that we embrace the recommendations of social distancing, handwashing, and wearing a face covering when we’re in public as some of the key defenses that we have against this virus,” Redfield explained.

“The pandemic is not over and it’s important to recognize that. While COVID-19 is still making headlines everywhere, we know the pandemic hasn’t affected everyone everywhere in the same way,” Butler said.

He noted that it is important to prepare for next fall and winter, when we can expect influenza season to complicate matters. “If anything, we must be overly-prepared for what we might face later this year,” he continued, adding that it is important to get vaccinated against influenza. “[F]lu and COVID-19 could be circulating together as we move into the fall and winter months,” he concluded.

Americans Mostly Following Guidelines

The agency also presented data from an article published online June 12 in Morbidity and Mortality Weekly Report that “underscores the fact that American people have taken mitigation efforts seriously…and it demonstrates our collective spirit in responding to the pandemic,” Butler said.

In it, the researchers describe representative panel surveys conducted among 4042 adults aged 18 years or older in New York City and Los Angeles — the two most populous cities in the United States — and “broadly across the United States” during May 5 to May 12, 2020.

Most respondents supported stay-at-home orders and nonessential business closures (United States, 79.5%; New York City, 86.7%; Los Angeles, 81.5%) and always or often wore cloth face coverings in public (United States, 74.1%; New York City, 89.6%; Los Angeles, 89.8%). Respondents also agreed that nonessential workers should remain at home (United States, 67.3%; New York City, 76.6%; Los Angeles, 69.1%), report Mark É. Czeisler, from Monash University and Austin Health, both in Melbourne, Australia, and colleagues.

There was wide support with public health guidelines: more than 87% of individuals in each area agreed that individuals should keep six feet of distance between themselves and others, and more than 82% in each area said that people should limit gatherings to fewer than 10 individuals.

At the time the survey was conducted, most were against indoor dining at restaurants (United States, 66.6%; New York City, 81.5%; Los Angeles, 71.8%).

 

 

Adherence “Widespread,” Survey Finds

Most respondents said they were adhering to COVID-19 mitigation guidance, including self-isolating (United States, 77.3%; New York City, 84.6%; Los Angeles, 83.0%) and “always or often” kept at least six feet between themselves and others (New York City, 85.7%; Los Angeles, 82.6%).

More than 85% of respondents in each of the three cohorts said they always or often avoided groups of 10 or more individuals.

About 90% of respondents said they had been in a public area during the last week, with 74.1% of those saying they always or often covered their face in public; respondents in New York City (89.6%) and Los Angeles (89.8%) had higher percentages of this behavior compared with respondents from the United States overall.

Most respondents felt that restrictions in their state were balanced or too lax (United States, 84.3%; New York City, 89.7%; Los Angeles, 79.7%) and said they would feel unsafe if restrictions were eased nationwide at that time (United States, 74.3%; New York City, 81.5%; Los Angeles, 73.4%). However, some individuals who said they would feel unsafe still wanted community mitigation strategies eased and were willing to accept risks resulting from lifting restrictions (United States, 17.1%; New York City, 12.6%; Los Angeles, 12.7%).

“Reported prevalence of self-isolation and feeling safe if community mitigation strategies were lifted differed significantly by age, employment status, and essential worker status among adults in the U.S. survey cohort,” the authors write.

Reports of self-isolation were highest among persons aged 18 to 24 years (92.3%) and lowest among those aged 45 to 54 years (71.5%). Yet, young adults aged 18 to 24 years (43.1%) were more than twice as likely to say they would feel safe if community mitigation strategies were eased, compared with adults aged 65 years or older (19.2%).

Almost half (47.2%) of employed respondents in the US cohort were essential workers; essential workers were “significantly less likely” to report self-isolating when compared with nonessential workers (63.1% vs 80.6%). Some 37.7% of essential workers said they would feel safe if community mitigation strategies were eased, compared with 23.7% of nonessential workers.

“Respondents who were male, employed, or essential workers were significantly more likely to report having been in public areas in the past week. Among respondents who had been in public areas during the preceding week, significantly higher percentages of women, adults aged ≥ 65 years, retired persons, and those living in urban areas reported wearing cloth face coverings,” the authors explain.

The findings are subject to several limitations, including self-reporting and the fact that some respondents may have known someone who tested positive for COVID-19 or died from it, the authors note. Respondents were not representative of the US population and the findings may not be generalizable.


This article first appeared on Medscape.com.

In its first media briefing on coronavirus in more than 3 months, the Centers for Disease Control and Prevention (CDC) warned that the COVID-19 pandemic is not over, and large gatherings pose a high risk for COVID-19 transmission.

Robert Redfield, MD, Director, CDC, and Jay C. Butler, MD, Deputy Director of Infectious Diseases and COVID-19 Response Incident Manager, CDC, discussed two new sets of CDC guidance on deciding to go out and attending group gatherings.

“We recognize that we’re all getting tired of staying at home; people long for the life that they had back in December, and as we head into the summer months, we know that Americans will be looking forward to reconnecting with family and friends and being able to attend events, and we want that to occur as safely as possible,” Butler said.

“Our recommendations evolved based on new information that becomes available, but it continues to be extremely important that we embrace the recommendations of social distancing, handwashing, and wearing a face covering when we’re in public as some of the key defenses that we have against this virus,” Redfield explained.

“The pandemic is not over and it’s important to recognize that. While COVID-19 is still making headlines everywhere, we know the pandemic hasn’t affected everyone everywhere in the same way,” Butler said.

He noted that it is important to prepare for next fall and winter, when we can expect influenza season to complicate matters. “If anything, we must be overly-prepared for what we might face later this year,” he continued, adding that it is important to get vaccinated against influenza. “[F]lu and COVID-19 could be circulating together as we move into the fall and winter months,” he concluded.

Americans Mostly Following Guidelines

The agency also presented data from an article published online June 12 in Morbidity and Mortality Weekly Report that “underscores the fact that American people have taken mitigation efforts seriously…and it demonstrates our collective spirit in responding to the pandemic,” Butler said.

In it, the researchers describe representative panel surveys conducted among 4042 adults aged 18 years or older in New York City and Los Angeles — the two most populous cities in the United States — and “broadly across the United States” during May 5 to May 12, 2020.

Most respondents supported stay-at-home orders and nonessential business closures (United States, 79.5%; New York City, 86.7%; Los Angeles, 81.5%) and always or often wore cloth face coverings in public (United States, 74.1%; New York City, 89.6%; Los Angeles, 89.8%). Respondents also agreed that nonessential workers should remain at home (United States, 67.3%; New York City, 76.6%; Los Angeles, 69.1%), report Mark É. Czeisler, from Monash University and Austin Health, both in Melbourne, Australia, and colleagues.

There was wide support with public health guidelines: more than 87% of individuals in each area agreed that individuals should keep six feet of distance between themselves and others, and more than 82% in each area said that people should limit gatherings to fewer than 10 individuals.

At the time the survey was conducted, most were against indoor dining at restaurants (United States, 66.6%; New York City, 81.5%; Los Angeles, 71.8%).

 

 

Adherence “Widespread,” Survey Finds

Most respondents said they were adhering to COVID-19 mitigation guidance, including self-isolating (United States, 77.3%; New York City, 84.6%; Los Angeles, 83.0%) and “always or often” kept at least six feet between themselves and others (New York City, 85.7%; Los Angeles, 82.6%).

More than 85% of respondents in each of the three cohorts said they always or often avoided groups of 10 or more individuals.

About 90% of respondents said they had been in a public area during the last week, with 74.1% of those saying they always or often covered their face in public; respondents in New York City (89.6%) and Los Angeles (89.8%) had higher percentages of this behavior compared with respondents from the United States overall.

Most respondents felt that restrictions in their state were balanced or too lax (United States, 84.3%; New York City, 89.7%; Los Angeles, 79.7%) and said they would feel unsafe if restrictions were eased nationwide at that time (United States, 74.3%; New York City, 81.5%; Los Angeles, 73.4%). However, some individuals who said they would feel unsafe still wanted community mitigation strategies eased and were willing to accept risks resulting from lifting restrictions (United States, 17.1%; New York City, 12.6%; Los Angeles, 12.7%).

“Reported prevalence of self-isolation and feeling safe if community mitigation strategies were lifted differed significantly by age, employment status, and essential worker status among adults in the U.S. survey cohort,” the authors write.

Reports of self-isolation were highest among persons aged 18 to 24 years (92.3%) and lowest among those aged 45 to 54 years (71.5%). Yet, young adults aged 18 to 24 years (43.1%) were more than twice as likely to say they would feel safe if community mitigation strategies were eased, compared with adults aged 65 years or older (19.2%).

Almost half (47.2%) of employed respondents in the US cohort were essential workers; essential workers were “significantly less likely” to report self-isolating when compared with nonessential workers (63.1% vs 80.6%). Some 37.7% of essential workers said they would feel safe if community mitigation strategies were eased, compared with 23.7% of nonessential workers.

“Respondents who were male, employed, or essential workers were significantly more likely to report having been in public areas in the past week. Among respondents who had been in public areas during the preceding week, significantly higher percentages of women, adults aged ≥ 65 years, retired persons, and those living in urban areas reported wearing cloth face coverings,” the authors explain.

The findings are subject to several limitations, including self-reporting and the fact that some respondents may have known someone who tested positive for COVID-19 or died from it, the authors note. Respondents were not representative of the US population and the findings may not be generalizable.


This article first appeared on Medscape.com.

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Many COVID patients shed virus in feces, even without GI symptoms

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Even without GI symptoms, many patients with COVID-19 shed viral RNA in feces, suggesting that stool testing and prevention of fecal-oral transmission may be needed to combat the ongoing pandemic, according to investigators.

A meta-analysis of 29 studies showed that 12% of patients with COVID-19 developed nausea, diarrhea, or vomiting, while 41% shed viral RNA in feces, reported lead author Sravanthi Parasa, MD, of Swedish Medical Center, Seattle.Writing in JAMA Network Open, Dr. Parasa and colleagues emphasized that respiratory symptoms remain the predominant form of disease; however, GI symptoms can occur.

“In fact, the first reported patient with COVID-19 in the U.S. reported GI symptoms of loose bowel movements and abdominal discomfort,” the investigators wrote, noting that the patient went on to test positive for severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) in both respiratory and stool specimens.

“This raises the question of inadvertent human-to-human transmission via the fecal route despite public health emphasis on droplet transmission and precautions for contact with respiratory secretions,” the investigators wrote.

To address this question, the investigators conducted a systematic review and meta-analysis involving 23 published and 6 preprint studies involving a total of 4,805 patients, all of whom tested positive for SARS-CoV-2 based on PCR results from nasopharyngeal swabs. Dr. Parasa and colleagues noted that most of the studies “scored between 8 and 10 on the MINORS quality assessment,” suggesting moderate quality.

Pooled data from these studies showed that 4.6% of patients reported nausea or vomiting, while 7.4% reported diarrhea. Such symptoms may serve as an early warning flag for clinicians, the investigators noted.

“[T]he presence of GI symptoms may portend a worse outcome for patients infected with SARS-CoV-2,” they wrote, citing a study by Pan and colleagues, which found that GI symptoms were associated with lower rates of recovery and hospital discharge.

Regardless of GI symptoms, 40.5% of patients in the meta-analysis tested positive for viral RNA in feces (95% confidence interval, 27.4%-55.1%). Duration of viral shedding in feces lasted up to 11 days after symptom onset, or in a single-patient case study, 18 days after hospitalization.

The investigators called these duration figures “particularly concerning,” especially in light of a study published by Xiao and colleagues, which showed that 23.3% of patients with negative respiratory tests were still shedding live virus in feces.

“[T]he fecal-oral route of transmission could be an additional potential source of infection spread,” wrote Dr. Parasa and colleagues. “Our results also suggest that testing of the virus in feces ... could be helpful in disease monitoring and surveillance.”

David A. Johnson, MD, professor of medicine and chief of gastroenterology at Eastern Virginia Medical School in Norfolk, said that the findings confirm what has been suspected for some time: GI disease is relatively common with COVID-19.

“The evidence is clear now that a sizable percentage of patients have GI symptoms,” Dr. Johnson said in an interview.

GI issues may precede respiratory signs, he added, so clinicians should be aware that nausea, vomiting, or diarrhea could be early indicators of COVID-19, and possibly, a worse outcome.

“The other highlight of this study is that stool shedding may be extended beyond respiratory shedding,” Dr. Johnson said.

He suggested that this finding could influence current CDC criteria, which define absence of infectious risk by two consecutive, negative nasopharyngeal swabs. Instead, fecal testing may be needed, he said, along with measures to prevent fecal-oral transmission.

Dr. Johnson expressed particular concern for risk of infection via toilet plume, in which toilet flushing aerosolizes viral particles.

“As much as people try to social distance by 6 feet – you can do that when you walk into a store, or a building, but you can’t necessarily do that when you walk into a public toilet, where the plume may have been expansive for a period of time,” he said. “That toilet may never really get cleaned to a high level of disinfection, and those droplets set up potential for fecal-oral spread.”

Dr. Sharma disclosed relationships with Medtronic, Fujifilm, Boston Scientific, and others. Dr. Johnson disclosed no relevant conflicts of interest.

SOURCE: Parasa S et al. JAMA Network Open. 2020 Jun 11. doi: 10.1001/jamanetworkopen.2020.11335.

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Even without GI symptoms, many patients with COVID-19 shed viral RNA in feces, suggesting that stool testing and prevention of fecal-oral transmission may be needed to combat the ongoing pandemic, according to investigators.

A meta-analysis of 29 studies showed that 12% of patients with COVID-19 developed nausea, diarrhea, or vomiting, while 41% shed viral RNA in feces, reported lead author Sravanthi Parasa, MD, of Swedish Medical Center, Seattle.Writing in JAMA Network Open, Dr. Parasa and colleagues emphasized that respiratory symptoms remain the predominant form of disease; however, GI symptoms can occur.

“In fact, the first reported patient with COVID-19 in the U.S. reported GI symptoms of loose bowel movements and abdominal discomfort,” the investigators wrote, noting that the patient went on to test positive for severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) in both respiratory and stool specimens.

“This raises the question of inadvertent human-to-human transmission via the fecal route despite public health emphasis on droplet transmission and precautions for contact with respiratory secretions,” the investigators wrote.

To address this question, the investigators conducted a systematic review and meta-analysis involving 23 published and 6 preprint studies involving a total of 4,805 patients, all of whom tested positive for SARS-CoV-2 based on PCR results from nasopharyngeal swabs. Dr. Parasa and colleagues noted that most of the studies “scored between 8 and 10 on the MINORS quality assessment,” suggesting moderate quality.

Pooled data from these studies showed that 4.6% of patients reported nausea or vomiting, while 7.4% reported diarrhea. Such symptoms may serve as an early warning flag for clinicians, the investigators noted.

“[T]he presence of GI symptoms may portend a worse outcome for patients infected with SARS-CoV-2,” they wrote, citing a study by Pan and colleagues, which found that GI symptoms were associated with lower rates of recovery and hospital discharge.

Regardless of GI symptoms, 40.5% of patients in the meta-analysis tested positive for viral RNA in feces (95% confidence interval, 27.4%-55.1%). Duration of viral shedding in feces lasted up to 11 days after symptom onset, or in a single-patient case study, 18 days after hospitalization.

The investigators called these duration figures “particularly concerning,” especially in light of a study published by Xiao and colleagues, which showed that 23.3% of patients with negative respiratory tests were still shedding live virus in feces.

“[T]he fecal-oral route of transmission could be an additional potential source of infection spread,” wrote Dr. Parasa and colleagues. “Our results also suggest that testing of the virus in feces ... could be helpful in disease monitoring and surveillance.”

David A. Johnson, MD, professor of medicine and chief of gastroenterology at Eastern Virginia Medical School in Norfolk, said that the findings confirm what has been suspected for some time: GI disease is relatively common with COVID-19.

“The evidence is clear now that a sizable percentage of patients have GI symptoms,” Dr. Johnson said in an interview.

GI issues may precede respiratory signs, he added, so clinicians should be aware that nausea, vomiting, or diarrhea could be early indicators of COVID-19, and possibly, a worse outcome.

“The other highlight of this study is that stool shedding may be extended beyond respiratory shedding,” Dr. Johnson said.

He suggested that this finding could influence current CDC criteria, which define absence of infectious risk by two consecutive, negative nasopharyngeal swabs. Instead, fecal testing may be needed, he said, along with measures to prevent fecal-oral transmission.

Dr. Johnson expressed particular concern for risk of infection via toilet plume, in which toilet flushing aerosolizes viral particles.

“As much as people try to social distance by 6 feet – you can do that when you walk into a store, or a building, but you can’t necessarily do that when you walk into a public toilet, where the plume may have been expansive for a period of time,” he said. “That toilet may never really get cleaned to a high level of disinfection, and those droplets set up potential for fecal-oral spread.”

Dr. Sharma disclosed relationships with Medtronic, Fujifilm, Boston Scientific, and others. Dr. Johnson disclosed no relevant conflicts of interest.

SOURCE: Parasa S et al. JAMA Network Open. 2020 Jun 11. doi: 10.1001/jamanetworkopen.2020.11335.

 

Even without GI symptoms, many patients with COVID-19 shed viral RNA in feces, suggesting that stool testing and prevention of fecal-oral transmission may be needed to combat the ongoing pandemic, according to investigators.

A meta-analysis of 29 studies showed that 12% of patients with COVID-19 developed nausea, diarrhea, or vomiting, while 41% shed viral RNA in feces, reported lead author Sravanthi Parasa, MD, of Swedish Medical Center, Seattle.Writing in JAMA Network Open, Dr. Parasa and colleagues emphasized that respiratory symptoms remain the predominant form of disease; however, GI symptoms can occur.

“In fact, the first reported patient with COVID-19 in the U.S. reported GI symptoms of loose bowel movements and abdominal discomfort,” the investigators wrote, noting that the patient went on to test positive for severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) in both respiratory and stool specimens.

“This raises the question of inadvertent human-to-human transmission via the fecal route despite public health emphasis on droplet transmission and precautions for contact with respiratory secretions,” the investigators wrote.

To address this question, the investigators conducted a systematic review and meta-analysis involving 23 published and 6 preprint studies involving a total of 4,805 patients, all of whom tested positive for SARS-CoV-2 based on PCR results from nasopharyngeal swabs. Dr. Parasa and colleagues noted that most of the studies “scored between 8 and 10 on the MINORS quality assessment,” suggesting moderate quality.

Pooled data from these studies showed that 4.6% of patients reported nausea or vomiting, while 7.4% reported diarrhea. Such symptoms may serve as an early warning flag for clinicians, the investigators noted.

“[T]he presence of GI symptoms may portend a worse outcome for patients infected with SARS-CoV-2,” they wrote, citing a study by Pan and colleagues, which found that GI symptoms were associated with lower rates of recovery and hospital discharge.

Regardless of GI symptoms, 40.5% of patients in the meta-analysis tested positive for viral RNA in feces (95% confidence interval, 27.4%-55.1%). Duration of viral shedding in feces lasted up to 11 days after symptom onset, or in a single-patient case study, 18 days after hospitalization.

The investigators called these duration figures “particularly concerning,” especially in light of a study published by Xiao and colleagues, which showed that 23.3% of patients with negative respiratory tests were still shedding live virus in feces.

“[T]he fecal-oral route of transmission could be an additional potential source of infection spread,” wrote Dr. Parasa and colleagues. “Our results also suggest that testing of the virus in feces ... could be helpful in disease monitoring and surveillance.”

David A. Johnson, MD, professor of medicine and chief of gastroenterology at Eastern Virginia Medical School in Norfolk, said that the findings confirm what has been suspected for some time: GI disease is relatively common with COVID-19.

“The evidence is clear now that a sizable percentage of patients have GI symptoms,” Dr. Johnson said in an interview.

GI issues may precede respiratory signs, he added, so clinicians should be aware that nausea, vomiting, or diarrhea could be early indicators of COVID-19, and possibly, a worse outcome.

“The other highlight of this study is that stool shedding may be extended beyond respiratory shedding,” Dr. Johnson said.

He suggested that this finding could influence current CDC criteria, which define absence of infectious risk by two consecutive, negative nasopharyngeal swabs. Instead, fecal testing may be needed, he said, along with measures to prevent fecal-oral transmission.

Dr. Johnson expressed particular concern for risk of infection via toilet plume, in which toilet flushing aerosolizes viral particles.

“As much as people try to social distance by 6 feet – you can do that when you walk into a store, or a building, but you can’t necessarily do that when you walk into a public toilet, where the plume may have been expansive for a period of time,” he said. “That toilet may never really get cleaned to a high level of disinfection, and those droplets set up potential for fecal-oral spread.”

Dr. Sharma disclosed relationships with Medtronic, Fujifilm, Boston Scientific, and others. Dr. Johnson disclosed no relevant conflicts of interest.

SOURCE: Parasa S et al. JAMA Network Open. 2020 Jun 11. doi: 10.1001/jamanetworkopen.2020.11335.

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Half of type 1 diabetes patients with COVID-19 manage at home

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New preliminary data from the T1D Exchange suggest that, although hyperglycemia and diabetic ketoacidosis (DKA) are common in people with type 1 diabetes who develop COVID-19, many are still able to manage the illness at home and overall mortality is relatively low.

The new findings – the first US data on individuals with type 1 diabetes and COVID-19 – were published online June 5 in Diabetes Care by Osagie A. Ebekozien, MD, vice president, quality improvement and population health at the T1D Exchange, and colleagues.

Two UK studies are the only prior ones to previously examine the topic.

The newly published study includes data as of May 5 on 64 individuals from a total of 64 US sites, including 15 T1D Exchange member clinics and an additional 49 endocrinology clinics from around the country. Since the paper was submitted, there are now 220 patients from 68 sites. Another publication with a more detailed analysis of risk factors and adjustment for confounders is planned for later this year.

Some of the findings from the preliminary data have shifted, but many aspects remain consistent, Ebekozien told Medscape Medical News.

“One thing still very true, even with the unpublished findings, is the influence of A1c and glycemic management. ...With higher A1c levels, we’re seeing more COVID-19 hospitalizations and worse outcomes,” he said.

And as has been generally reported for COVID-19, high body mass index was a major risk factor in the preliminary dataset – and remains so.

There were two deaths in the preliminary report, both individuals with comorbidities in addition to type 1 diabetes, Ebekozien said. There have been a few more deaths in the larger dataset, but the mortality rate remains relatively low.

Interestingly, females predominate in both cohorts. That may be a reporting phenomenon, another factor that is being analyzed.

Hyperglycemia Remains a Major Risk Factor

The study is specifically being conducted by the T1D Exchange’s Quality Improvement Collaborative, which Ebekozien heads.

Data were obtained for 33 patients with type 1 diabetes who tested positive for COVID-19, and another 31 who were classified as “COVID-19–like” because they had symptoms consistent with COVID-19, as identified by the Centers for Disease Control and Prevention, but hadn’t been tested for the virus.

For all 64 patients, the mean age was 20.9 years and two thirds (65.6%) were aged 18 or younger. A higher proportion of the COVID-19–like patients were pediatric than the confirmed cases. The larger dataset includes more adult patients, Ebekozien told Medscape Medical News.

Overall, 60.9% of patients were female. Nearly half were white, a quarter Hispanic, and 18.8% black. More confirmed COVID-19 cases were black compared with suspected cases (30.3% vs 6.5%).

Median A1c for the overall group (including suspected COVID-19 cases) was 8.0%, but it was 8.5% among confirmed cases. Overall, six patients (9.8%) presented with new-onset type 1 diabetes after they developed COVID-19.

Hyperglycemia was present in half (32) of patients overall. DKA occurred in 19 people (30.2%): 15 of the confirmed COVID-19 cases (45.5%) versus just 4 (13.3%) of the COVID-19–like cases. Nausea was reported in 30.2% of patients overall.

Other symptoms were typical of COVID-19, including fever (41.3%), dry cough (38.1%), and shortness of breath (27.0%). Loss of taste and smell was less common, at just 9.5% overall.

Obesity was present in 39.7% of patients overall, with similar proportions in the confirmed and suspected COVID-19 groups. Hypertension and/or cardiovascular disease were present in 14.3% of patients overall, and the rate was similar between the two subgroups.

One of the two patients who died was a 79-year-old man who had hypertension and a prior stroke in addition to type 1 diabetes. The other was a 19-year-old woman with a history of asthma who developed a pulmonary embolism during the onset of COVID-19. Neither had DKA.

 

 

Even in Type 1 Diabetes, COVID-19 Can Be Managed at Home

Overall, 34.9% of patients were able to manage COVID-19 entirely at home, with 27.3% of the confirmed and 43.3% of the suspected cases able to do so.

At the other extreme, 22.2% of patients overall were admitted to the intensive care unit; 30.3% of the confirmed versus 13.3% of suspected cases.

Including the small proportion of patients sent home after being seen in emergency or urgent care, overall roughly half were not admitted to hospital.

“Interestingly, even in this preliminary study, half were managed at home via telemedicine with an endocrinologist and infectious disease specialist. ... I think it continues to be a case-by-case clinical decision between the patient and their provider,” Ebekozien said.

“But, we’re seeing a good number of patients who are managed at home and the symptoms resolve in a week or two, and the illness runs its course, and they don’t have to even be seen,” he added.

The research team is also collecting data on barriers to remote care, including challenges with telemedicine and how frontline providers are navigating them.

“Those are all things that our future paper will be able to shed more light on,” he explained.

Endocrinologists around the country are invited to report cases of COVID-19 in patients with type 1 diabetes to the T1D Exchange by emailing QI@T1Dexchange.org.

And in fact, Ebekozien also requested that clinicians with a large type 1 diabetes population also report if they’ve had no COVID-19 cases.

“Even if they haven’t had a case, that’s very useful information for us to know. One of the things we want to calculate down the line is the incidence ratio. Not all participating sites have had a case.”

Endocrinologists from all the participating sites have formed a dedicated community that meets regularly via webinars to share information, he noted. “It’s been a very selfless effort to work collaboratively as a community to quickly answer critical questions.”

The Helmsley Charitable Trust funds the T1D Exchange Quality Improvement Collaborative. The T1D Exchange received financial support for this study from Abbott Diabetes, Dexcom, JDRF, Insulet Corporation, Lilly, Medtronic, and Tandem Diabetes Care. No other relevant financial relationships were reported.
 

This article first appeared on Medscape.com.

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New preliminary data from the T1D Exchange suggest that, although hyperglycemia and diabetic ketoacidosis (DKA) are common in people with type 1 diabetes who develop COVID-19, many are still able to manage the illness at home and overall mortality is relatively low.

The new findings – the first US data on individuals with type 1 diabetes and COVID-19 – were published online June 5 in Diabetes Care by Osagie A. Ebekozien, MD, vice president, quality improvement and population health at the T1D Exchange, and colleagues.

Two UK studies are the only prior ones to previously examine the topic.

The newly published study includes data as of May 5 on 64 individuals from a total of 64 US sites, including 15 T1D Exchange member clinics and an additional 49 endocrinology clinics from around the country. Since the paper was submitted, there are now 220 patients from 68 sites. Another publication with a more detailed analysis of risk factors and adjustment for confounders is planned for later this year.

Some of the findings from the preliminary data have shifted, but many aspects remain consistent, Ebekozien told Medscape Medical News.

“One thing still very true, even with the unpublished findings, is the influence of A1c and glycemic management. ...With higher A1c levels, we’re seeing more COVID-19 hospitalizations and worse outcomes,” he said.

And as has been generally reported for COVID-19, high body mass index was a major risk factor in the preliminary dataset – and remains so.

There were two deaths in the preliminary report, both individuals with comorbidities in addition to type 1 diabetes, Ebekozien said. There have been a few more deaths in the larger dataset, but the mortality rate remains relatively low.

Interestingly, females predominate in both cohorts. That may be a reporting phenomenon, another factor that is being analyzed.

Hyperglycemia Remains a Major Risk Factor

The study is specifically being conducted by the T1D Exchange’s Quality Improvement Collaborative, which Ebekozien heads.

Data were obtained for 33 patients with type 1 diabetes who tested positive for COVID-19, and another 31 who were classified as “COVID-19–like” because they had symptoms consistent with COVID-19, as identified by the Centers for Disease Control and Prevention, but hadn’t been tested for the virus.

For all 64 patients, the mean age was 20.9 years and two thirds (65.6%) were aged 18 or younger. A higher proportion of the COVID-19–like patients were pediatric than the confirmed cases. The larger dataset includes more adult patients, Ebekozien told Medscape Medical News.

Overall, 60.9% of patients were female. Nearly half were white, a quarter Hispanic, and 18.8% black. More confirmed COVID-19 cases were black compared with suspected cases (30.3% vs 6.5%).

Median A1c for the overall group (including suspected COVID-19 cases) was 8.0%, but it was 8.5% among confirmed cases. Overall, six patients (9.8%) presented with new-onset type 1 diabetes after they developed COVID-19.

Hyperglycemia was present in half (32) of patients overall. DKA occurred in 19 people (30.2%): 15 of the confirmed COVID-19 cases (45.5%) versus just 4 (13.3%) of the COVID-19–like cases. Nausea was reported in 30.2% of patients overall.

Other symptoms were typical of COVID-19, including fever (41.3%), dry cough (38.1%), and shortness of breath (27.0%). Loss of taste and smell was less common, at just 9.5% overall.

Obesity was present in 39.7% of patients overall, with similar proportions in the confirmed and suspected COVID-19 groups. Hypertension and/or cardiovascular disease were present in 14.3% of patients overall, and the rate was similar between the two subgroups.

One of the two patients who died was a 79-year-old man who had hypertension and a prior stroke in addition to type 1 diabetes. The other was a 19-year-old woman with a history of asthma who developed a pulmonary embolism during the onset of COVID-19. Neither had DKA.

 

 

Even in Type 1 Diabetes, COVID-19 Can Be Managed at Home

Overall, 34.9% of patients were able to manage COVID-19 entirely at home, with 27.3% of the confirmed and 43.3% of the suspected cases able to do so.

At the other extreme, 22.2% of patients overall were admitted to the intensive care unit; 30.3% of the confirmed versus 13.3% of suspected cases.

Including the small proportion of patients sent home after being seen in emergency or urgent care, overall roughly half were not admitted to hospital.

“Interestingly, even in this preliminary study, half were managed at home via telemedicine with an endocrinologist and infectious disease specialist. ... I think it continues to be a case-by-case clinical decision between the patient and their provider,” Ebekozien said.

“But, we’re seeing a good number of patients who are managed at home and the symptoms resolve in a week or two, and the illness runs its course, and they don’t have to even be seen,” he added.

The research team is also collecting data on barriers to remote care, including challenges with telemedicine and how frontline providers are navigating them.

“Those are all things that our future paper will be able to shed more light on,” he explained.

Endocrinologists around the country are invited to report cases of COVID-19 in patients with type 1 diabetes to the T1D Exchange by emailing QI@T1Dexchange.org.

And in fact, Ebekozien also requested that clinicians with a large type 1 diabetes population also report if they’ve had no COVID-19 cases.

“Even if they haven’t had a case, that’s very useful information for us to know. One of the things we want to calculate down the line is the incidence ratio. Not all participating sites have had a case.”

Endocrinologists from all the participating sites have formed a dedicated community that meets regularly via webinars to share information, he noted. “It’s been a very selfless effort to work collaboratively as a community to quickly answer critical questions.”

The Helmsley Charitable Trust funds the T1D Exchange Quality Improvement Collaborative. The T1D Exchange received financial support for this study from Abbott Diabetes, Dexcom, JDRF, Insulet Corporation, Lilly, Medtronic, and Tandem Diabetes Care. No other relevant financial relationships were reported.
 

This article first appeared on Medscape.com.

New preliminary data from the T1D Exchange suggest that, although hyperglycemia and diabetic ketoacidosis (DKA) are common in people with type 1 diabetes who develop COVID-19, many are still able to manage the illness at home and overall mortality is relatively low.

The new findings – the first US data on individuals with type 1 diabetes and COVID-19 – were published online June 5 in Diabetes Care by Osagie A. Ebekozien, MD, vice president, quality improvement and population health at the T1D Exchange, and colleagues.

Two UK studies are the only prior ones to previously examine the topic.

The newly published study includes data as of May 5 on 64 individuals from a total of 64 US sites, including 15 T1D Exchange member clinics and an additional 49 endocrinology clinics from around the country. Since the paper was submitted, there are now 220 patients from 68 sites. Another publication with a more detailed analysis of risk factors and adjustment for confounders is planned for later this year.

Some of the findings from the preliminary data have shifted, but many aspects remain consistent, Ebekozien told Medscape Medical News.

“One thing still very true, even with the unpublished findings, is the influence of A1c and glycemic management. ...With higher A1c levels, we’re seeing more COVID-19 hospitalizations and worse outcomes,” he said.

And as has been generally reported for COVID-19, high body mass index was a major risk factor in the preliminary dataset – and remains so.

There were two deaths in the preliminary report, both individuals with comorbidities in addition to type 1 diabetes, Ebekozien said. There have been a few more deaths in the larger dataset, but the mortality rate remains relatively low.

Interestingly, females predominate in both cohorts. That may be a reporting phenomenon, another factor that is being analyzed.

Hyperglycemia Remains a Major Risk Factor

The study is specifically being conducted by the T1D Exchange’s Quality Improvement Collaborative, which Ebekozien heads.

Data were obtained for 33 patients with type 1 diabetes who tested positive for COVID-19, and another 31 who were classified as “COVID-19–like” because they had symptoms consistent with COVID-19, as identified by the Centers for Disease Control and Prevention, but hadn’t been tested for the virus.

For all 64 patients, the mean age was 20.9 years and two thirds (65.6%) were aged 18 or younger. A higher proportion of the COVID-19–like patients were pediatric than the confirmed cases. The larger dataset includes more adult patients, Ebekozien told Medscape Medical News.

Overall, 60.9% of patients were female. Nearly half were white, a quarter Hispanic, and 18.8% black. More confirmed COVID-19 cases were black compared with suspected cases (30.3% vs 6.5%).

Median A1c for the overall group (including suspected COVID-19 cases) was 8.0%, but it was 8.5% among confirmed cases. Overall, six patients (9.8%) presented with new-onset type 1 diabetes after they developed COVID-19.

Hyperglycemia was present in half (32) of patients overall. DKA occurred in 19 people (30.2%): 15 of the confirmed COVID-19 cases (45.5%) versus just 4 (13.3%) of the COVID-19–like cases. Nausea was reported in 30.2% of patients overall.

Other symptoms were typical of COVID-19, including fever (41.3%), dry cough (38.1%), and shortness of breath (27.0%). Loss of taste and smell was less common, at just 9.5% overall.

Obesity was present in 39.7% of patients overall, with similar proportions in the confirmed and suspected COVID-19 groups. Hypertension and/or cardiovascular disease were present in 14.3% of patients overall, and the rate was similar between the two subgroups.

One of the two patients who died was a 79-year-old man who had hypertension and a prior stroke in addition to type 1 diabetes. The other was a 19-year-old woman with a history of asthma who developed a pulmonary embolism during the onset of COVID-19. Neither had DKA.

 

 

Even in Type 1 Diabetes, COVID-19 Can Be Managed at Home

Overall, 34.9% of patients were able to manage COVID-19 entirely at home, with 27.3% of the confirmed and 43.3% of the suspected cases able to do so.

At the other extreme, 22.2% of patients overall were admitted to the intensive care unit; 30.3% of the confirmed versus 13.3% of suspected cases.

Including the small proportion of patients sent home after being seen in emergency or urgent care, overall roughly half were not admitted to hospital.

“Interestingly, even in this preliminary study, half were managed at home via telemedicine with an endocrinologist and infectious disease specialist. ... I think it continues to be a case-by-case clinical decision between the patient and their provider,” Ebekozien said.

“But, we’re seeing a good number of patients who are managed at home and the symptoms resolve in a week or two, and the illness runs its course, and they don’t have to even be seen,” he added.

The research team is also collecting data on barriers to remote care, including challenges with telemedicine and how frontline providers are navigating them.

“Those are all things that our future paper will be able to shed more light on,” he explained.

Endocrinologists around the country are invited to report cases of COVID-19 in patients with type 1 diabetes to the T1D Exchange by emailing QI@T1Dexchange.org.

And in fact, Ebekozien also requested that clinicians with a large type 1 diabetes population also report if they’ve had no COVID-19 cases.

“Even if they haven’t had a case, that’s very useful information for us to know. One of the things we want to calculate down the line is the incidence ratio. Not all participating sites have had a case.”

Endocrinologists from all the participating sites have formed a dedicated community that meets regularly via webinars to share information, he noted. “It’s been a very selfless effort to work collaboratively as a community to quickly answer critical questions.”

The Helmsley Charitable Trust funds the T1D Exchange Quality Improvement Collaborative. The T1D Exchange received financial support for this study from Abbott Diabetes, Dexcom, JDRF, Insulet Corporation, Lilly, Medtronic, and Tandem Diabetes Care. No other relevant financial relationships were reported.
 

This article first appeared on Medscape.com.

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If you reopen it, will they come?

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On April 16, the White House released federal guidelines for reopening American businesses – followed 3 days later by specific recommendations from the Centers for Medicare and Medicaid Services for health care practices in areas with a low incidence of COVID-19. Since then, a slew of resources and guidelines have emerged to help you safely reopen your medical practice.

Dr. Joseph S. Eastern

Depending on where you live, you may have already reopened (or even never closed), or you may be awaiting the relaxation of restrictions in your state. (As I write this on June 10, the stay-at-home order in my state, New Jersey, is being rescinded.)

The big question, of course, is whether patients can be convinced that it is safe to leave their homes and come to your office. The answer may depend on how well you time your reopening and adhere to the appropriate federal, state, and independent guidelines.

The federal guidelines have three sections: criteria, which outline conditions each region or state should satisfy before reopening; preparedness, which lists how states should prepare for reopening; and phase guidelines, which detail responsibilities of individuals and employers during distinct reopening phases.

You should pay the most attention to the “criteria” section. The key question to ask: “Has my state or region satisfied the basic criteria for reopening?”

Those criteria are as follows:

  • Symptoms reported within a 14-day period should be on a downward trajectory.
  • Cases documented (or positive tests as a percentage of total tests) within a 14-day period should also be on a downward trajectory.
  • Hospitals should be treating all patients without crisis care. They should also have a robust testing program in place for at-risk health care workers.

If your area meets these criteria, you can proceed to the CMS recommendations. They cover general advice related to personal protective equipment (PPE), workforce availability, facility considerations, sanitation protocols, supplies, and testing capacity.

The key takeaway: As long as your area has the resources to quickly respond to a surge of COVID-19 cases, you can start offering care to non-COVID patients. Keep seeing patients via telehealth as often as possible, and prioritize surgical/procedural care and high-complexity chronic disease management before moving on to preventive and cosmetic services.

The American Medical Association has issued its own checklist of criteria for reopening your practice to supplement the federal guidelines. Highlights include the following:

  • Sit down with a calendar and pick an expected reopening day. Ideally, this should include a “soft reopening.” Make a plan to stock necessary PPE and write down plans for cleaning and staffing if an employee or patient is diagnosed with COVID-19 after visiting your office.
  • Take a stepwise approach so you can identify challenges early and address them. It’s important to figure out which visits can continue via telehealth, and begin with just a few in-person visits each day. Plan out a schedule and clearly communicate it to patients, clinicians, and staff.
  • Patient safety is your top concern. Encourage patients to visit without companions whenever possible, and of course, all individuals who visit the office should wear a cloth face covering.
  • Screen employees for fevers and other symptoms of COVID-19; remember that those records are subject to HIPAA rules and must be kept confidential. Minimize contact between employees as much as possible.
  • Do your best to screen patients before in-person visits, to verify they don’t have symptoms of COVID-19. Consider creating a script that office staff can use to contact patients 24 hours before they come in. Use this as a chance to ask about symptoms, and explain any reopening logistics they should know about.
  • Contact your malpractice insurance carrier to discuss whether you need to make any changes to your coverage.

This would also be a great time to review your confidentiality, privacy, and data security protocols. COVID-19 presents new challenges for data privacy – for example, if you must inform coworkers or patients that they have come into contact with someone who tested positive. Make a plan that follows HIPAA guidelines during COVID-19. Also, make sure you have a plan for handling issues like paid sick leave or reporting COVID-19 cases to your local health department.

Another useful resource is the Medical Group Management Association’s COVID-19 Medical Practice Reopening Checklist. You can use it to confirm that you are addressing all the important items, and that you haven’t missed anything.

As for me, I am advising patients who are reluctant to seek treatment that many medical problems pose more risk than COVID-19, faster treatment means better outcomes, and because we maintain strict disinfection protocols, they are far less likely to be infected with COVID-19 in my office than, say, at a grocery store.
 

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 dermnews@mdedge.com.

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On April 16, the White House released federal guidelines for reopening American businesses – followed 3 days later by specific recommendations from the Centers for Medicare and Medicaid Services for health care practices in areas with a low incidence of COVID-19. Since then, a slew of resources and guidelines have emerged to help you safely reopen your medical practice.

Dr. Joseph S. Eastern

Depending on where you live, you may have already reopened (or even never closed), or you may be awaiting the relaxation of restrictions in your state. (As I write this on June 10, the stay-at-home order in my state, New Jersey, is being rescinded.)

The big question, of course, is whether patients can be convinced that it is safe to leave their homes and come to your office. The answer may depend on how well you time your reopening and adhere to the appropriate federal, state, and independent guidelines.

The federal guidelines have three sections: criteria, which outline conditions each region or state should satisfy before reopening; preparedness, which lists how states should prepare for reopening; and phase guidelines, which detail responsibilities of individuals and employers during distinct reopening phases.

You should pay the most attention to the “criteria” section. The key question to ask: “Has my state or region satisfied the basic criteria for reopening?”

Those criteria are as follows:

  • Symptoms reported within a 14-day period should be on a downward trajectory.
  • Cases documented (or positive tests as a percentage of total tests) within a 14-day period should also be on a downward trajectory.
  • Hospitals should be treating all patients without crisis care. They should also have a robust testing program in place for at-risk health care workers.

If your area meets these criteria, you can proceed to the CMS recommendations. They cover general advice related to personal protective equipment (PPE), workforce availability, facility considerations, sanitation protocols, supplies, and testing capacity.

The key takeaway: As long as your area has the resources to quickly respond to a surge of COVID-19 cases, you can start offering care to non-COVID patients. Keep seeing patients via telehealth as often as possible, and prioritize surgical/procedural care and high-complexity chronic disease management before moving on to preventive and cosmetic services.

The American Medical Association has issued its own checklist of criteria for reopening your practice to supplement the federal guidelines. Highlights include the following:

  • Sit down with a calendar and pick an expected reopening day. Ideally, this should include a “soft reopening.” Make a plan to stock necessary PPE and write down plans for cleaning and staffing if an employee or patient is diagnosed with COVID-19 after visiting your office.
  • Take a stepwise approach so you can identify challenges early and address them. It’s important to figure out which visits can continue via telehealth, and begin with just a few in-person visits each day. Plan out a schedule and clearly communicate it to patients, clinicians, and staff.
  • Patient safety is your top concern. Encourage patients to visit without companions whenever possible, and of course, all individuals who visit the office should wear a cloth face covering.
  • Screen employees for fevers and other symptoms of COVID-19; remember that those records are subject to HIPAA rules and must be kept confidential. Minimize contact between employees as much as possible.
  • Do your best to screen patients before in-person visits, to verify they don’t have symptoms of COVID-19. Consider creating a script that office staff can use to contact patients 24 hours before they come in. Use this as a chance to ask about symptoms, and explain any reopening logistics they should know about.
  • Contact your malpractice insurance carrier to discuss whether you need to make any changes to your coverage.

This would also be a great time to review your confidentiality, privacy, and data security protocols. COVID-19 presents new challenges for data privacy – for example, if you must inform coworkers or patients that they have come into contact with someone who tested positive. Make a plan that follows HIPAA guidelines during COVID-19. Also, make sure you have a plan for handling issues like paid sick leave or reporting COVID-19 cases to your local health department.

Another useful resource is the Medical Group Management Association’s COVID-19 Medical Practice Reopening Checklist. You can use it to confirm that you are addressing all the important items, and that you haven’t missed anything.

As for me, I am advising patients who are reluctant to seek treatment that many medical problems pose more risk than COVID-19, faster treatment means better outcomes, and because we maintain strict disinfection protocols, they are far less likely to be infected with COVID-19 in my office than, say, at a grocery store.
 

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 dermnews@mdedge.com.

On April 16, the White House released federal guidelines for reopening American businesses – followed 3 days later by specific recommendations from the Centers for Medicare and Medicaid Services for health care practices in areas with a low incidence of COVID-19. Since then, a slew of resources and guidelines have emerged to help you safely reopen your medical practice.

Dr. Joseph S. Eastern

Depending on where you live, you may have already reopened (or even never closed), or you may be awaiting the relaxation of restrictions in your state. (As I write this on June 10, the stay-at-home order in my state, New Jersey, is being rescinded.)

The big question, of course, is whether patients can be convinced that it is safe to leave their homes and come to your office. The answer may depend on how well you time your reopening and adhere to the appropriate federal, state, and independent guidelines.

The federal guidelines have three sections: criteria, which outline conditions each region or state should satisfy before reopening; preparedness, which lists how states should prepare for reopening; and phase guidelines, which detail responsibilities of individuals and employers during distinct reopening phases.

You should pay the most attention to the “criteria” section. The key question to ask: “Has my state or region satisfied the basic criteria for reopening?”

Those criteria are as follows:

  • Symptoms reported within a 14-day period should be on a downward trajectory.
  • Cases documented (or positive tests as a percentage of total tests) within a 14-day period should also be on a downward trajectory.
  • Hospitals should be treating all patients without crisis care. They should also have a robust testing program in place for at-risk health care workers.

If your area meets these criteria, you can proceed to the CMS recommendations. They cover general advice related to personal protective equipment (PPE), workforce availability, facility considerations, sanitation protocols, supplies, and testing capacity.

The key takeaway: As long as your area has the resources to quickly respond to a surge of COVID-19 cases, you can start offering care to non-COVID patients. Keep seeing patients via telehealth as often as possible, and prioritize surgical/procedural care and high-complexity chronic disease management before moving on to preventive and cosmetic services.

The American Medical Association has issued its own checklist of criteria for reopening your practice to supplement the federal guidelines. Highlights include the following:

  • Sit down with a calendar and pick an expected reopening day. Ideally, this should include a “soft reopening.” Make a plan to stock necessary PPE and write down plans for cleaning and staffing if an employee or patient is diagnosed with COVID-19 after visiting your office.
  • Take a stepwise approach so you can identify challenges early and address them. It’s important to figure out which visits can continue via telehealth, and begin with just a few in-person visits each day. Plan out a schedule and clearly communicate it to patients, clinicians, and staff.
  • Patient safety is your top concern. Encourage patients to visit without companions whenever possible, and of course, all individuals who visit the office should wear a cloth face covering.
  • Screen employees for fevers and other symptoms of COVID-19; remember that those records are subject to HIPAA rules and must be kept confidential. Minimize contact between employees as much as possible.
  • Do your best to screen patients before in-person visits, to verify they don’t have symptoms of COVID-19. Consider creating a script that office staff can use to contact patients 24 hours before they come in. Use this as a chance to ask about symptoms, and explain any reopening logistics they should know about.
  • Contact your malpractice insurance carrier to discuss whether you need to make any changes to your coverage.

This would also be a great time to review your confidentiality, privacy, and data security protocols. COVID-19 presents new challenges for data privacy – for example, if you must inform coworkers or patients that they have come into contact with someone who tested positive. Make a plan that follows HIPAA guidelines during COVID-19. Also, make sure you have a plan for handling issues like paid sick leave or reporting COVID-19 cases to your local health department.

Another useful resource is the Medical Group Management Association’s COVID-19 Medical Practice Reopening Checklist. You can use it to confirm that you are addressing all the important items, and that you haven’t missed anything.

As for me, I am advising patients who are reluctant to seek treatment that many medical problems pose more risk than COVID-19, faster treatment means better outcomes, and because we maintain strict disinfection protocols, they are far less likely to be infected with COVID-19 in my office than, say, at a grocery store.
 

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 dermnews@mdedge.com.

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Daily Recap: Feds seek COVID-19 info through app, hospitalists take on new roles

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Here are the stories our MDedge editors across specialties think you need to know about today:

FDA seeks COVID-19 info through CURE ID

Federal health officials are asking clinicians to use the free CURE ID mobile app and web platform as a tool to collect information on the treatment of patients with COVID-19. CURE ID is an Internet-based data repository first developed in 2013 as a collaboration between the Food and Drug Administration and the National Center for Advancing Translational Sciences, part of the National Institutes of Health. It provides licensed clinicians worldwide with an opportunity to report novel uses of existing drugs for patients with difficult-to-treat infectious diseases, including COVID-19, through a website, a smartphone, or other mobile device. “By utilizing the CURE ID platform now for COVID-19 case collection – in conjunction with data gathered from other registries, EHR systems, and clinical trials – data collected during an outbreak can be improved and coordinated,” said Heather A. Stone, MPH, a health science policy analyst in the office of medical policy at the FDA’s Center for Drug Evaluation and Research. “This may allow us to find possible treatments to help ease this pandemic, and prepare us better to fight the next one.” Read more.
 

Hospitalists take on new roles in COVID era

Whether it’s working shifts in the ICU, caring for ventilator patients, or reporting to postanesthesia care units and post-acute or step-down units, hospitalists are stepping into a variety of new roles as part of their frontline response to the COVID-19 pandemic. Valerie Vaughn, MD, a hospitalist with Michigan Medicine and assistant professor of medicine at the University of Michigan in Ann Arbor, was doing research on how to reduce overuse of antibiotics in hospitals when the COVID-19 crisis hit and dramatically redefined her job. “We were afraid that we might have 3,000 to 5,000 hospitalized COVID patients by now, based on predictive modeling done while the pandemic was still growing exponentially,” she explained. Although Michigan continues to have high COVID-19 infection rates, centered on nearby Detroit, “things are a lot better today than they were 4 weeks ago.” Dr. Vaughn helped to mobilize a team of 25 hospitalists, along with other health care professionals, who volunteered to manage COVID-19 patients in the ICU and other hospital units. Read more.

COVID-19 recommendations for rheumatic disease treatment

The European League Against Rheumatism (EULAR) issued provisional recommendations for the management of rheumatic and musculoskeletal diseases in the context of SARS-CoV-2. Contrary to earlier expectations, there is no indication that patients with rheumatic and musculoskeletal diseases have a higher risk of contracting the virus or have a worse course if they do, according to the task force that worked on the recommendations. The task force also pointed out that rheumatology drugs are being used to treat COVID-19 patients who don’t have rheumatic diseases, raising the possibility of a shortage of disease-modifying antirheumatic drugs. Read more.

Mental health visits are 19% of ED costs

 

Mental and substance use disorders represented 19% of all emergency department visits in 2017 and cost $14.6 billion, according to figures from the Agency for Healthcare Research and Quality. The most costly mental and substance use disorder diagnosis was anxiety and fear-related disorders, accounting for $5.6 billion worth of visits, following by depressive disorders and alcohol-related disorders. Read more.

 

 

Food deserts linked to health issues in pregnancy

Living in a neighborhood lacking adequate access to affordable, high-quality food is associated with a somewhat greater risk of developing pregnancy morbidity, according to an observational study. Researchers found that women who lived in a food desert had a 1.6 times greater odds of pregnancy comorbidity than if they did not. “An additional, albeit less obvious factor that may be unique to patients suffering disproportionately from obstetric morbidity is exposure to toxic elements,” the researchers reported in Obstetrics & Gynecology. “It has been shown in a previous study that low-income, predominantly black communities of pregnant women may suffer disproportionately from lead or arsenic exposure.” Read more.
 

For more on COVID-19, visit our Resource Center. All of our latest news is available on MDedge.com.

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Here are the stories our MDedge editors across specialties think you need to know about today:

FDA seeks COVID-19 info through CURE ID

Federal health officials are asking clinicians to use the free CURE ID mobile app and web platform as a tool to collect information on the treatment of patients with COVID-19. CURE ID is an Internet-based data repository first developed in 2013 as a collaboration between the Food and Drug Administration and the National Center for Advancing Translational Sciences, part of the National Institutes of Health. It provides licensed clinicians worldwide with an opportunity to report novel uses of existing drugs for patients with difficult-to-treat infectious diseases, including COVID-19, through a website, a smartphone, or other mobile device. “By utilizing the CURE ID platform now for COVID-19 case collection – in conjunction with data gathered from other registries, EHR systems, and clinical trials – data collected during an outbreak can be improved and coordinated,” said Heather A. Stone, MPH, a health science policy analyst in the office of medical policy at the FDA’s Center for Drug Evaluation and Research. “This may allow us to find possible treatments to help ease this pandemic, and prepare us better to fight the next one.” Read more.
 

Hospitalists take on new roles in COVID era

Whether it’s working shifts in the ICU, caring for ventilator patients, or reporting to postanesthesia care units and post-acute or step-down units, hospitalists are stepping into a variety of new roles as part of their frontline response to the COVID-19 pandemic. Valerie Vaughn, MD, a hospitalist with Michigan Medicine and assistant professor of medicine at the University of Michigan in Ann Arbor, was doing research on how to reduce overuse of antibiotics in hospitals when the COVID-19 crisis hit and dramatically redefined her job. “We were afraid that we might have 3,000 to 5,000 hospitalized COVID patients by now, based on predictive modeling done while the pandemic was still growing exponentially,” she explained. Although Michigan continues to have high COVID-19 infection rates, centered on nearby Detroit, “things are a lot better today than they were 4 weeks ago.” Dr. Vaughn helped to mobilize a team of 25 hospitalists, along with other health care professionals, who volunteered to manage COVID-19 patients in the ICU and other hospital units. Read more.

COVID-19 recommendations for rheumatic disease treatment

The European League Against Rheumatism (EULAR) issued provisional recommendations for the management of rheumatic and musculoskeletal diseases in the context of SARS-CoV-2. Contrary to earlier expectations, there is no indication that patients with rheumatic and musculoskeletal diseases have a higher risk of contracting the virus or have a worse course if they do, according to the task force that worked on the recommendations. The task force also pointed out that rheumatology drugs are being used to treat COVID-19 patients who don’t have rheumatic diseases, raising the possibility of a shortage of disease-modifying antirheumatic drugs. Read more.

Mental health visits are 19% of ED costs

 

Mental and substance use disorders represented 19% of all emergency department visits in 2017 and cost $14.6 billion, according to figures from the Agency for Healthcare Research and Quality. The most costly mental and substance use disorder diagnosis was anxiety and fear-related disorders, accounting for $5.6 billion worth of visits, following by depressive disorders and alcohol-related disorders. Read more.

 

 

Food deserts linked to health issues in pregnancy

Living in a neighborhood lacking adequate access to affordable, high-quality food is associated with a somewhat greater risk of developing pregnancy morbidity, according to an observational study. Researchers found that women who lived in a food desert had a 1.6 times greater odds of pregnancy comorbidity than if they did not. “An additional, albeit less obvious factor that may be unique to patients suffering disproportionately from obstetric morbidity is exposure to toxic elements,” the researchers reported in Obstetrics & Gynecology. “It has been shown in a previous study that low-income, predominantly black communities of pregnant women may suffer disproportionately from lead or arsenic exposure.” Read more.
 

For more on COVID-19, visit our Resource Center. All of our latest news is available on MDedge.com.

 

Here are the stories our MDedge editors across specialties think you need to know about today:

FDA seeks COVID-19 info through CURE ID

Federal health officials are asking clinicians to use the free CURE ID mobile app and web platform as a tool to collect information on the treatment of patients with COVID-19. CURE ID is an Internet-based data repository first developed in 2013 as a collaboration between the Food and Drug Administration and the National Center for Advancing Translational Sciences, part of the National Institutes of Health. It provides licensed clinicians worldwide with an opportunity to report novel uses of existing drugs for patients with difficult-to-treat infectious diseases, including COVID-19, through a website, a smartphone, or other mobile device. “By utilizing the CURE ID platform now for COVID-19 case collection – in conjunction with data gathered from other registries, EHR systems, and clinical trials – data collected during an outbreak can be improved and coordinated,” said Heather A. Stone, MPH, a health science policy analyst in the office of medical policy at the FDA’s Center for Drug Evaluation and Research. “This may allow us to find possible treatments to help ease this pandemic, and prepare us better to fight the next one.” Read more.
 

Hospitalists take on new roles in COVID era

Whether it’s working shifts in the ICU, caring for ventilator patients, or reporting to postanesthesia care units and post-acute or step-down units, hospitalists are stepping into a variety of new roles as part of their frontline response to the COVID-19 pandemic. Valerie Vaughn, MD, a hospitalist with Michigan Medicine and assistant professor of medicine at the University of Michigan in Ann Arbor, was doing research on how to reduce overuse of antibiotics in hospitals when the COVID-19 crisis hit and dramatically redefined her job. “We were afraid that we might have 3,000 to 5,000 hospitalized COVID patients by now, based on predictive modeling done while the pandemic was still growing exponentially,” she explained. Although Michigan continues to have high COVID-19 infection rates, centered on nearby Detroit, “things are a lot better today than they were 4 weeks ago.” Dr. Vaughn helped to mobilize a team of 25 hospitalists, along with other health care professionals, who volunteered to manage COVID-19 patients in the ICU and other hospital units. Read more.

COVID-19 recommendations for rheumatic disease treatment

The European League Against Rheumatism (EULAR) issued provisional recommendations for the management of rheumatic and musculoskeletal diseases in the context of SARS-CoV-2. Contrary to earlier expectations, there is no indication that patients with rheumatic and musculoskeletal diseases have a higher risk of contracting the virus or have a worse course if they do, according to the task force that worked on the recommendations. The task force also pointed out that rheumatology drugs are being used to treat COVID-19 patients who don’t have rheumatic diseases, raising the possibility of a shortage of disease-modifying antirheumatic drugs. Read more.

Mental health visits are 19% of ED costs

 

Mental and substance use disorders represented 19% of all emergency department visits in 2017 and cost $14.6 billion, according to figures from the Agency for Healthcare Research and Quality. The most costly mental and substance use disorder diagnosis was anxiety and fear-related disorders, accounting for $5.6 billion worth of visits, following by depressive disorders and alcohol-related disorders. Read more.

 

 

Food deserts linked to health issues in pregnancy

Living in a neighborhood lacking adequate access to affordable, high-quality food is associated with a somewhat greater risk of developing pregnancy morbidity, according to an observational study. Researchers found that women who lived in a food desert had a 1.6 times greater odds of pregnancy comorbidity than if they did not. “An additional, albeit less obvious factor that may be unique to patients suffering disproportionately from obstetric morbidity is exposure to toxic elements,” the researchers reported in Obstetrics & Gynecology. “It has been shown in a previous study that low-income, predominantly black communities of pregnant women may suffer disproportionately from lead or arsenic exposure.” Read more.
 

For more on COVID-19, visit our Resource Center. All of our latest news is available on MDedge.com.

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Entheseal lesions, bone density linked with incident PsA in psoriasis patients

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Structural entheseal lesions and reduced bone mineral density detected using high-resolution CT imaging of a pair of knuckle joints in patients with psoriasis strongly linked with subsequent development of psoriatic arthritis (PsA) in a single-center study with 114 patients followed for an average of 2.3 years.

Dr. David Simon

“These findings substantiate the concept of mechano-inflammation in the pathogenesis of psoriatic disease,” and suggest that interventions with high efficacy for controlling entheseal inflammation may be a “particularly valuable strategy in interfering with the onset of PsA in patients with psoriatic disease,” David Simon, MD, said at the annual European Congress of Rheumatology, held online this year due to COVID-19.

The study, which is now published in Arthritis & Rheumatology, began with 377 patients with psoriasis who had been referred to the University Hospital in Erlangen, Germany, during 2011-2018, and who tested positive on the German Psoriasis Arthritis Diagnostic questionnaire. The researchers excluded patients with existing signs of PsA, any arthritis or enthesitis or other signs of inflammatory rheumatic disease, and they also excluded patients who had not undergoing a high-resolution peripheral quantitative CT (HR-pQCT) examination of the second and third metacarpal joints of the patient’s nondominant hand, which left 114 patients for their analysis. During a mean follow-up of 28 months, 24 patients (27%) developed PsA. The study patients were an average age of 45 years, and they had been diagnosed with psoriasis for an average of about 16 years.



Dr. Simon and associates used the baseline HR-pQCT scans to make two assessments of each patient: the presence of structural entheseal lesions (SEL) in the two metacarpal joints and the calculated volumetric bone mineral density (vBMD). Their analysis showed that the number and severity of SEL were increased among patients who later developed PsA. In a multivariable model that adjusted for age, sex, body mass index, duration of psoriasis, and arthralgia, patients with any SEL had a fivefold higher rate of developing PsA, compared with patients with no SEL, reported Dr. Simon, a rheumatologist at Erlangen University Hospital.

The analysis of vBMD also showed a strong link between bone density at the entheseal sites of the two studied joints and subsequent PsA development. For every standard deviation increase in vBMD at these sites the subsequent rate of PsA incidence fell by about 67% in an analysis that controlled for the same covariants as well as presence of SEL. The same relationship between higher vBMD and a lower risk for PsA held for both total vBMD measurement and for cortical vBMD, but only at the entheseal site. Levels of vBMD at the intra-articular site of the joints had no statistically significant relationship with subsequent PsA development.

The two metrics also appeared to identify additive risks. Nearly 90% of patients with at least one SEL who also had low vBMD at the entheseal site developed PsA during follow-up, compared with about a 50% rate among patients with at least one SEL but high vBMD.

courtesy EULAR
Dr. Iain McInnes

The imaging method used to run these analyses, HR-pQCT, remains for the time being a “research technique” that “is not generalizable for routine practice,” but further development of this method or of a surrogate measure might make it feasible for future widespread practice, commented Iain McInnes, MD, PhD, president of the European League Against Rheumatism and professor of rheumatology and director of the Institute of Infection, Immunity, and Inflammation at the University of Glasgow.

“We’ve thought for many years that psoriasis and psoriatic arthritis are on a spectrum, and this work is consistent with the idea that some patients with psoriasis develop tissue involvement at entheses and joints,” Dr. McInnes said in an interview. The higher incidence of PsA seen in patients with adverse SEL and vBMD markers was in an “interesting range” that warrants further study. A next step is to run an intervention study in which patients with these adverse markers would receive an intervention randomized against placebo to see if it improved their outcomes, he suggested. Good candidate agents to study in psoriasis patients who have these adverse markers include drugs that inhibit the action of interleukin-17, drugs that target the p19 cytokine subunit of IL-23, and possibly Janus kinase inhibitor drugs.

Dr. Simon has been a consultant to AbbVie and Eli Lilly, a speaker on behalf of Eli Lilly, Janssen, and Novartis, and has received research funding from Eli Lilly and Novartis. Dr. McInnes has been a consultant to AbbVie, Bristol-Myers Squibb, Celgene, Eli Lilly, Gilead, Janssen, Novartis, Pfizer, and UCB, and he has received research funding from Bristol-Myers Squibb, Celgene, Eli Lilly, Janssen, and UCB.

SOURCE: Simon D et al. Ann Rheum Dis. 2020 Jun;79[suppl 1]:33-4, Abstract OP0051.

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Structural entheseal lesions and reduced bone mineral density detected using high-resolution CT imaging of a pair of knuckle joints in patients with psoriasis strongly linked with subsequent development of psoriatic arthritis (PsA) in a single-center study with 114 patients followed for an average of 2.3 years.

Dr. David Simon

“These findings substantiate the concept of mechano-inflammation in the pathogenesis of psoriatic disease,” and suggest that interventions with high efficacy for controlling entheseal inflammation may be a “particularly valuable strategy in interfering with the onset of PsA in patients with psoriatic disease,” David Simon, MD, said at the annual European Congress of Rheumatology, held online this year due to COVID-19.

The study, which is now published in Arthritis & Rheumatology, began with 377 patients with psoriasis who had been referred to the University Hospital in Erlangen, Germany, during 2011-2018, and who tested positive on the German Psoriasis Arthritis Diagnostic questionnaire. The researchers excluded patients with existing signs of PsA, any arthritis or enthesitis or other signs of inflammatory rheumatic disease, and they also excluded patients who had not undergoing a high-resolution peripheral quantitative CT (HR-pQCT) examination of the second and third metacarpal joints of the patient’s nondominant hand, which left 114 patients for their analysis. During a mean follow-up of 28 months, 24 patients (27%) developed PsA. The study patients were an average age of 45 years, and they had been diagnosed with psoriasis for an average of about 16 years.



Dr. Simon and associates used the baseline HR-pQCT scans to make two assessments of each patient: the presence of structural entheseal lesions (SEL) in the two metacarpal joints and the calculated volumetric bone mineral density (vBMD). Their analysis showed that the number and severity of SEL were increased among patients who later developed PsA. In a multivariable model that adjusted for age, sex, body mass index, duration of psoriasis, and arthralgia, patients with any SEL had a fivefold higher rate of developing PsA, compared with patients with no SEL, reported Dr. Simon, a rheumatologist at Erlangen University Hospital.

The analysis of vBMD also showed a strong link between bone density at the entheseal sites of the two studied joints and subsequent PsA development. For every standard deviation increase in vBMD at these sites the subsequent rate of PsA incidence fell by about 67% in an analysis that controlled for the same covariants as well as presence of SEL. The same relationship between higher vBMD and a lower risk for PsA held for both total vBMD measurement and for cortical vBMD, but only at the entheseal site. Levels of vBMD at the intra-articular site of the joints had no statistically significant relationship with subsequent PsA development.

The two metrics also appeared to identify additive risks. Nearly 90% of patients with at least one SEL who also had low vBMD at the entheseal site developed PsA during follow-up, compared with about a 50% rate among patients with at least one SEL but high vBMD.

courtesy EULAR
Dr. Iain McInnes

The imaging method used to run these analyses, HR-pQCT, remains for the time being a “research technique” that “is not generalizable for routine practice,” but further development of this method or of a surrogate measure might make it feasible for future widespread practice, commented Iain McInnes, MD, PhD, president of the European League Against Rheumatism and professor of rheumatology and director of the Institute of Infection, Immunity, and Inflammation at the University of Glasgow.

“We’ve thought for many years that psoriasis and psoriatic arthritis are on a spectrum, and this work is consistent with the idea that some patients with psoriasis develop tissue involvement at entheses and joints,” Dr. McInnes said in an interview. The higher incidence of PsA seen in patients with adverse SEL and vBMD markers was in an “interesting range” that warrants further study. A next step is to run an intervention study in which patients with these adverse markers would receive an intervention randomized against placebo to see if it improved their outcomes, he suggested. Good candidate agents to study in psoriasis patients who have these adverse markers include drugs that inhibit the action of interleukin-17, drugs that target the p19 cytokine subunit of IL-23, and possibly Janus kinase inhibitor drugs.

Dr. Simon has been a consultant to AbbVie and Eli Lilly, a speaker on behalf of Eli Lilly, Janssen, and Novartis, and has received research funding from Eli Lilly and Novartis. Dr. McInnes has been a consultant to AbbVie, Bristol-Myers Squibb, Celgene, Eli Lilly, Gilead, Janssen, Novartis, Pfizer, and UCB, and he has received research funding from Bristol-Myers Squibb, Celgene, Eli Lilly, Janssen, and UCB.

SOURCE: Simon D et al. Ann Rheum Dis. 2020 Jun;79[suppl 1]:33-4, Abstract OP0051.

Structural entheseal lesions and reduced bone mineral density detected using high-resolution CT imaging of a pair of knuckle joints in patients with psoriasis strongly linked with subsequent development of psoriatic arthritis (PsA) in a single-center study with 114 patients followed for an average of 2.3 years.

Dr. David Simon

“These findings substantiate the concept of mechano-inflammation in the pathogenesis of psoriatic disease,” and suggest that interventions with high efficacy for controlling entheseal inflammation may be a “particularly valuable strategy in interfering with the onset of PsA in patients with psoriatic disease,” David Simon, MD, said at the annual European Congress of Rheumatology, held online this year due to COVID-19.

The study, which is now published in Arthritis & Rheumatology, began with 377 patients with psoriasis who had been referred to the University Hospital in Erlangen, Germany, during 2011-2018, and who tested positive on the German Psoriasis Arthritis Diagnostic questionnaire. The researchers excluded patients with existing signs of PsA, any arthritis or enthesitis or other signs of inflammatory rheumatic disease, and they also excluded patients who had not undergoing a high-resolution peripheral quantitative CT (HR-pQCT) examination of the second and third metacarpal joints of the patient’s nondominant hand, which left 114 patients for their analysis. During a mean follow-up of 28 months, 24 patients (27%) developed PsA. The study patients were an average age of 45 years, and they had been diagnosed with psoriasis for an average of about 16 years.



Dr. Simon and associates used the baseline HR-pQCT scans to make two assessments of each patient: the presence of structural entheseal lesions (SEL) in the two metacarpal joints and the calculated volumetric bone mineral density (vBMD). Their analysis showed that the number and severity of SEL were increased among patients who later developed PsA. In a multivariable model that adjusted for age, sex, body mass index, duration of psoriasis, and arthralgia, patients with any SEL had a fivefold higher rate of developing PsA, compared with patients with no SEL, reported Dr. Simon, a rheumatologist at Erlangen University Hospital.

The analysis of vBMD also showed a strong link between bone density at the entheseal sites of the two studied joints and subsequent PsA development. For every standard deviation increase in vBMD at these sites the subsequent rate of PsA incidence fell by about 67% in an analysis that controlled for the same covariants as well as presence of SEL. The same relationship between higher vBMD and a lower risk for PsA held for both total vBMD measurement and for cortical vBMD, but only at the entheseal site. Levels of vBMD at the intra-articular site of the joints had no statistically significant relationship with subsequent PsA development.

The two metrics also appeared to identify additive risks. Nearly 90% of patients with at least one SEL who also had low vBMD at the entheseal site developed PsA during follow-up, compared with about a 50% rate among patients with at least one SEL but high vBMD.

courtesy EULAR
Dr. Iain McInnes

The imaging method used to run these analyses, HR-pQCT, remains for the time being a “research technique” that “is not generalizable for routine practice,” but further development of this method or of a surrogate measure might make it feasible for future widespread practice, commented Iain McInnes, MD, PhD, president of the European League Against Rheumatism and professor of rheumatology and director of the Institute of Infection, Immunity, and Inflammation at the University of Glasgow.

“We’ve thought for many years that psoriasis and psoriatic arthritis are on a spectrum, and this work is consistent with the idea that some patients with psoriasis develop tissue involvement at entheses and joints,” Dr. McInnes said in an interview. The higher incidence of PsA seen in patients with adverse SEL and vBMD markers was in an “interesting range” that warrants further study. A next step is to run an intervention study in which patients with these adverse markers would receive an intervention randomized against placebo to see if it improved their outcomes, he suggested. Good candidate agents to study in psoriasis patients who have these adverse markers include drugs that inhibit the action of interleukin-17, drugs that target the p19 cytokine subunit of IL-23, and possibly Janus kinase inhibitor drugs.

Dr. Simon has been a consultant to AbbVie and Eli Lilly, a speaker on behalf of Eli Lilly, Janssen, and Novartis, and has received research funding from Eli Lilly and Novartis. Dr. McInnes has been a consultant to AbbVie, Bristol-Myers Squibb, Celgene, Eli Lilly, Gilead, Janssen, Novartis, Pfizer, and UCB, and he has received research funding from Bristol-Myers Squibb, Celgene, Eli Lilly, Janssen, and UCB.

SOURCE: Simon D et al. Ann Rheum Dis. 2020 Jun;79[suppl 1]:33-4, Abstract OP0051.

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Hospitalists stretch into new roles on COVID-19 front lines

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‘Every single day is different’

In the midst of the COVID-19 pandemic, health systems, hospitals, and hospitalists – especially in hot spots like New York, Detroit, or Boston – have been challenged to stretch limits, redefine roles, and redeploy critical staff in response to rapidly changing needs on the ground.

Dr. Valerie Vaughn wearing personal protective equipment at Michigan Health

Many hospitalists are working above and beyond their normal duties, sometimes beyond their training, specialty, or comfort zone and are rising to the occasion in ways they never imagined. These include doing shifts in ICUs, working with ventilator patients, and reporting to other atypical sites of care like postanesthesia care units and post-acute or step-down units.

Valerie Vaughn, MD, MSc, a hospitalist with Michigan Medicine and assistant professor of medicine at the University of Michigan in Ann Arbor, was doing research on how to reduce overuse of antibiotics in hospitals when the COVID-19 crisis hit and dramatically redefined her job. “We were afraid that we might have 3,000 to 5,000 hospitalized COVID patients by now, based on predictive modeling done while the pandemic was still growing exponentially,” she explained. Although Michigan continues to have high COVID-19 infection rates, centered on nearby Detroit, “things are a lot better today than they were 4 weeks ago.”

Dr. Vaughn helped to mobilize a team of 25 hospitalists, along with other health care providers, who volunteered to manage COVID-19 patients in the ICU and other hospital units. She was asked to help develop an all-COVID unit called the Regional Infectious Containment Unit or RICU, which opened March 16. Then, when the RICU became full, it was supplemented by two COVID-19 Moderate Care Units staffed by hospitalists who had “learned the ropes” in the RICU.

Both of these new models were defined in relation to the ICUs at Michigan Medicine – which were doubling in capacity, up to 200 beds at last count – and to the provision of intensive-level and long-term ventilator care for the sickest patients. The moderate care units are for patients who are not on ventilators but still very sick, for example, those receiving massive high-flow oxygen, often with a medical do-not-resuscitate/do-not-intubate order. “We established these units to do everything (medically) short of vents,” Dr. Vaughn said.

“We are having in-depth conversations about goals of care with patients soon after they arrive at the hospital. We know outcomes from ventilators are worse for COVID-positive patients who have comorbidities, and we’re using that information to inform these conversations. We’ve given scripts to clinicians to help guide them in leading these conversations. We can do other things than `use ventilators to manage their symptoms. But these are still difficult conversations,” Dr. Vaughn said.

Boston Hope Medical Center

“We also engaged palliative care early on and asked them to round with us on every [COVID] patient – until demand got too high.” The bottleneck has been the number of ICU beds available, she explained. “If you want your patient to come in and take that bed, make sure you’ve talked to the family about it.”

The COVID-19 team developed guidelines printed on pocket cards addressing critical care issues such as a refresher on how to treat acute respiratory distress syndrome and how to use vasopressors. (See the COVID-19 Continuing Medical Education Portal for web-accessible educational resources developed by Michigan Health).

It’s amazing how quickly patients can become very sick with COVID-19, Dr. Vaughn said. “One of the good things to happen from the beginning with our RICU is that a group of doctors became COVID care experts very quickly. We joined four to five hospitalists and their teams with each intensivist, so one critical care expert is there to do teaching and answer clinicians’ questions. The hospitalists coordinate the COVID care and talk to the families.”

Working on the front lines of this crisis, Dr. Vaughn said, has generated a powerful sense of purpose and camaraderie, creating bonds like in war time. “All of us on our days off feel a twinge of guilt for not being there in the hospital. The sense of gratitude we get from patients and families has been enormous, even when we were telling them bad news. That just brings us to tears.”

One of the hardest things for the doctors practicing above their typical scope of practice is that, when something bad happens, they can’t know whether it was a mistake on their part or not, she noted. “But I’ve never been so proud of our group or to be a hospitalist. No one has complained or pushed back. Everyone has responded by saying: ‘What can I do to help?’ ”
 

 

 

Enough work in hospital medicine

Hospitalists had not been deployed to care for ICU patients at Beth Israel Deaconess Medical Center (BIDMC) in Boston, a major hot spot for COVID-19, said Joseph Ming Wah Li, MD, SFHM, director of the hospital medicine program at BIDMC, when he spoke to The Hospitalist in mid-May. That’s because there were plenty of hospital medicine assignments to keep them busy. Dr. Li leads a service of 120 hospitalists practicing at four hospitals.

“As we speak today, we have 300 patients with COVID, with 70 or 80 of them in our ICU. I’m taking care of 17 patients today, 15 of them COVID-positive, and the other two placed in a former radiology holding suite adapted for COVID-negative patients. Our postanesthesia care unit is now an ICU filled with COVID patients,” he said.

“Half of my day is seeing patients and the other half I’m on Zoom calls. I’m also one of the resource allocation officers for BIDMC,” Dr. Li said. He helped to create a standard of care for the hospital, addressing what to do if there weren’t enough ICU beds or ventilators. “We’ve never actualized it and probably won’t, but it was important to go through this exercise, with a lot of discussion up front.”

Dr. Haki Laho

Haki Laho, MD, an orthopedic hospitalist at New England Baptist Hospital (NEBH), also in Boston, has been redeployed to care for a different population of patients as his system tries to bunch patients. “All of a sudden – within hours and days – at the beginning of the pandemic and based on the recommendations, our whole system decided to stop all elective procedures and devote the resources to COVID,” he said.

NEBH is Beth Israel Lahey Health’s 141-bed orthopedic and surgical hospital, and the system has tried to keep the specialty facility COVID-19–free as much as possible, with the COVID-19 patients grouped together at BIDMC. Dr. Laho’s orthopedic hospitalist group, just five doctors, has been managing the influx of medical patients with multiple comorbidities – not COVID-19–infected but still a different kind of patient than they are used to.

“So far, so good. We’re dealing with it,” he said. “But if one of us got sick, the others would have to step up and do more shifts. We are physicians, internal medicine trained, but since my residency I hadn’t had to deal with these kinds of issues on a daily basis, such as setting up IV lines. I feel like I am back in residency mode.”
 

Convention Center medicine

Dr. Amy Baughman

Another Boston hospitalist, Amy Baughman, MD, who practices at Massachusetts General Hospital, is using her skills in a new setting, serving as a co-medical director at Boston Hope Medical Center, a 1,000-bed field hospital for patients with COVID-19. Open since April 10 and housed in the Boston Convention and Exhibition Center, it is a four-way collaboration between the Commonwealth of Massachusetts, the City of Boston, Partners HealthCare, and the Boston Health Care for the Homeless Program.

Boston Hope is divided into a post-acute care section for recovering COVID-19 patients and a respite section for undomiciled patients with COVID-19 who need a place to safely quarantine. Built for a maximum of 1,000 beds, it is currently using fewer, with 83 patients on the post-acute side and 73 on the respite side as of May 12. A total of 370 and 315, respectively, had been admitted through May 12.

The team had 5 days to put the field hospital together with the help of the Army National Guard. “During that first week I was installing hand sanitizer dispensers and making [personal protective equipment] signs. Everyone here has had to do things like that,” Dr. Baughman said. “We’ve had to be incredibly creative in our staffing, using doctors from primary care and subspecialties including dermatology, radiology, and orthopedics. We had to fast-track trainings on how to use EPIC and to provide post-acute COVID care. How do you simultaneously build a medical facility and lead teams to provide high quality care?”

Dr. Baughman still works hospitalist shifts half-time at Massachusetts General. Her prior experience providing post-acute care in the VA system was helpful in creating the post-acute level of care at Boston Hope.

“My medical director role involves supervising, staffing, and scheduling. My co-medical director, Dr. Kerri Palamara, and I also supervise the clinical care,” she said. “There are a lot of systems issues, like ordering labs or prescriptions, with couriers going back and forth. And we developed clinical pathways, such as for [deep vein thrombosis] prophylaxis or for COVID retesting to determine when it is safe to end a quarantine. We’re just now rolling out virtual specialist consultations,” she noted.

Dr. Amy Baughman in personal protective equipment

“It has gone incredibly well. So much of it has been about our ability and willingness to work hard, and take feedback and go forward. We don’t have time to harp on things. We have to be very solution oriented. At the same time, honestly, it’s been fun. Every single day is different,” Dr. Baughman said.

“It’s been an opportunity to use my skills in a totally new setting, and at a level of responsibility I haven’t had before, although that’s probably a common theme with COVID-19. I was put on this team because I am a hospitalist,” she said. “I think hospitalists have been the backbone of the response to COVID in this country. It’s been an opportunity for our specialty to shine. We need to embrace the opportunity.”
 

Balancing expertise and supervision

Mount Sinai Hospital (MSH) in Manhattan is in the New York epicenter of the COVID-19 crisis and has mobilized large numbers of pulmonary critical care and anesthesia physicians to staff up multiple ICUs for COVID-19 patients, said Andrew Dunn, MD, chief of the division of hospital medicine at Mount Sinai School of Medicine.

Dr. Andrew Dunn

“My hospitalist group is covering many step-down units, medical wards, and atypical locations, providing advanced oxygen therapies, [bilevel positive airway pressure], high-flow nasal cannulas, and managing some patients on ventilators,” he said.

MSH has teaching services with house staff and nonteaching services. “We combined them into a unified service with house staff dispersed across all of the teams. We drafted a lot of nonhospitalists from different specialties to be attendings, and that has given us a tiered model, with a hospitalist supervising three or four nonhospitalist-led teams. Although the supervising hospitalists carry no patient caseloads of their own, this is primarily a clinical rather than an administrative role.”

At the peak, there were 40 rounding teams at MSH, each with a typical census of 15 patients or more, which meant that 10 supervisory hospitalists were responsible for 300 to 400 patients. “What we learned first was the need to balance the level of expertise. For example, a team may include a postgraduate year 3 resident and a radiology intern,” Dr. Dunn said. As COVID-19 census has started coming down, supervisory hospitalists are returning to direct care attending roles, and some hospitalists have been shared across the Mount Sinai system’s hospitals.

Dr. Dunn’s advice for hospitalists filling a supervisory role like this in a tiered model: Make sure you talk to your team the night before the first day of a scheduling block and try to address as many of their questions as possible. “If you wait until the morning of the shift to connect with them, anxiety will be high. But after going through a couple of scheduling cycles, we find that things are getting better. I think we’ve paid a lot of attention to the risks of burnout by our physicians. We’re using a model of 4 days on/4 off.”

Another variation on these themes is Joshua Shatzkes, MD, assistant professor of medicine and cardiology at Mount Sinai, who practices outpatient cardiology at MSH and in several off-site offices in Brooklyn. He saw early on that COVID-19 would have a huge effect on his practice, so he volunteered to help out with inpatient care. “I made it known to my chief that I was available, and I was deployed in the first week, after a weekend of cramming webinars and lectures on critical care and pulling out critical concepts that I already knew.”

Dr. Joshua Shatzkes

Dr. Shatzkes said his career path led him into outpatient cardiology 11 years ago, where he was quickly too busy to see his patients when they went into the hospital, even though he missed hospital medicine. Working as a temporary hospitalist with the arrival of COVID-19, he has been invigorated and mobilized by the experience and reminded of why he went to medical school in the first place. “Each day’s shift went quickly but felt long. At the end of the day, I was tired but not exhausted. When I walked out of a patient’s room, they could tell, ‘This is a doctor who cared for me,’ ” he said.

After Dr. Shatzkes volunteered, he got the call from his division chief. “I was officially deployed for a 4-day shift at Mount Sinai and then as a backup.” On his first morning as an inpatient doctor, he was still getting oriented when calls started coming from the nurses. “I had five patients struggling to breathe. Their degree of hypoxia was remarkable. I kept them out of the ICU, at least for that day.”

Since then, he has continued to follow some of those patients in the hospital, along with some from his outpatient practice who were hospitalized, and others referred by colleagues, while remaining available to his outpatients through telemedicine. When this is all over, Dr. Shatzkes said, he would love to find a way to incorporate a hospital practice in his job – depending on the realities of New York traffic.

“Joshua is not a hospitalist, but he went on service and felt so fulfilled and rewarded, he asked me if he could stay on service,” Dr. Dunn said. “I also got an email from the nurse manager on the unit. They want him back.”

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‘Every single day is different’

‘Every single day is different’

In the midst of the COVID-19 pandemic, health systems, hospitals, and hospitalists – especially in hot spots like New York, Detroit, or Boston – have been challenged to stretch limits, redefine roles, and redeploy critical staff in response to rapidly changing needs on the ground.

Dr. Valerie Vaughn wearing personal protective equipment at Michigan Health

Many hospitalists are working above and beyond their normal duties, sometimes beyond their training, specialty, or comfort zone and are rising to the occasion in ways they never imagined. These include doing shifts in ICUs, working with ventilator patients, and reporting to other atypical sites of care like postanesthesia care units and post-acute or step-down units.

Valerie Vaughn, MD, MSc, a hospitalist with Michigan Medicine and assistant professor of medicine at the University of Michigan in Ann Arbor, was doing research on how to reduce overuse of antibiotics in hospitals when the COVID-19 crisis hit and dramatically redefined her job. “We were afraid that we might have 3,000 to 5,000 hospitalized COVID patients by now, based on predictive modeling done while the pandemic was still growing exponentially,” she explained. Although Michigan continues to have high COVID-19 infection rates, centered on nearby Detroit, “things are a lot better today than they were 4 weeks ago.”

Dr. Vaughn helped to mobilize a team of 25 hospitalists, along with other health care providers, who volunteered to manage COVID-19 patients in the ICU and other hospital units. She was asked to help develop an all-COVID unit called the Regional Infectious Containment Unit or RICU, which opened March 16. Then, when the RICU became full, it was supplemented by two COVID-19 Moderate Care Units staffed by hospitalists who had “learned the ropes” in the RICU.

Both of these new models were defined in relation to the ICUs at Michigan Medicine – which were doubling in capacity, up to 200 beds at last count – and to the provision of intensive-level and long-term ventilator care for the sickest patients. The moderate care units are for patients who are not on ventilators but still very sick, for example, those receiving massive high-flow oxygen, often with a medical do-not-resuscitate/do-not-intubate order. “We established these units to do everything (medically) short of vents,” Dr. Vaughn said.

“We are having in-depth conversations about goals of care with patients soon after they arrive at the hospital. We know outcomes from ventilators are worse for COVID-positive patients who have comorbidities, and we’re using that information to inform these conversations. We’ve given scripts to clinicians to help guide them in leading these conversations. We can do other things than `use ventilators to manage their symptoms. But these are still difficult conversations,” Dr. Vaughn said.

Boston Hope Medical Center

“We also engaged palliative care early on and asked them to round with us on every [COVID] patient – until demand got too high.” The bottleneck has been the number of ICU beds available, she explained. “If you want your patient to come in and take that bed, make sure you’ve talked to the family about it.”

The COVID-19 team developed guidelines printed on pocket cards addressing critical care issues such as a refresher on how to treat acute respiratory distress syndrome and how to use vasopressors. (See the COVID-19 Continuing Medical Education Portal for web-accessible educational resources developed by Michigan Health).

It’s amazing how quickly patients can become very sick with COVID-19, Dr. Vaughn said. “One of the good things to happen from the beginning with our RICU is that a group of doctors became COVID care experts very quickly. We joined four to five hospitalists and their teams with each intensivist, so one critical care expert is there to do teaching and answer clinicians’ questions. The hospitalists coordinate the COVID care and talk to the families.”

Working on the front lines of this crisis, Dr. Vaughn said, has generated a powerful sense of purpose and camaraderie, creating bonds like in war time. “All of us on our days off feel a twinge of guilt for not being there in the hospital. The sense of gratitude we get from patients and families has been enormous, even when we were telling them bad news. That just brings us to tears.”

One of the hardest things for the doctors practicing above their typical scope of practice is that, when something bad happens, they can’t know whether it was a mistake on their part or not, she noted. “But I’ve never been so proud of our group or to be a hospitalist. No one has complained or pushed back. Everyone has responded by saying: ‘What can I do to help?’ ”
 

 

 

Enough work in hospital medicine

Hospitalists had not been deployed to care for ICU patients at Beth Israel Deaconess Medical Center (BIDMC) in Boston, a major hot spot for COVID-19, said Joseph Ming Wah Li, MD, SFHM, director of the hospital medicine program at BIDMC, when he spoke to The Hospitalist in mid-May. That’s because there were plenty of hospital medicine assignments to keep them busy. Dr. Li leads a service of 120 hospitalists practicing at four hospitals.

“As we speak today, we have 300 patients with COVID, with 70 or 80 of them in our ICU. I’m taking care of 17 patients today, 15 of them COVID-positive, and the other two placed in a former radiology holding suite adapted for COVID-negative patients. Our postanesthesia care unit is now an ICU filled with COVID patients,” he said.

“Half of my day is seeing patients and the other half I’m on Zoom calls. I’m also one of the resource allocation officers for BIDMC,” Dr. Li said. He helped to create a standard of care for the hospital, addressing what to do if there weren’t enough ICU beds or ventilators. “We’ve never actualized it and probably won’t, but it was important to go through this exercise, with a lot of discussion up front.”

Dr. Haki Laho

Haki Laho, MD, an orthopedic hospitalist at New England Baptist Hospital (NEBH), also in Boston, has been redeployed to care for a different population of patients as his system tries to bunch patients. “All of a sudden – within hours and days – at the beginning of the pandemic and based on the recommendations, our whole system decided to stop all elective procedures and devote the resources to COVID,” he said.

NEBH is Beth Israel Lahey Health’s 141-bed orthopedic and surgical hospital, and the system has tried to keep the specialty facility COVID-19–free as much as possible, with the COVID-19 patients grouped together at BIDMC. Dr. Laho’s orthopedic hospitalist group, just five doctors, has been managing the influx of medical patients with multiple comorbidities – not COVID-19–infected but still a different kind of patient than they are used to.

“So far, so good. We’re dealing with it,” he said. “But if one of us got sick, the others would have to step up and do more shifts. We are physicians, internal medicine trained, but since my residency I hadn’t had to deal with these kinds of issues on a daily basis, such as setting up IV lines. I feel like I am back in residency mode.”
 

Convention Center medicine

Dr. Amy Baughman

Another Boston hospitalist, Amy Baughman, MD, who practices at Massachusetts General Hospital, is using her skills in a new setting, serving as a co-medical director at Boston Hope Medical Center, a 1,000-bed field hospital for patients with COVID-19. Open since April 10 and housed in the Boston Convention and Exhibition Center, it is a four-way collaboration between the Commonwealth of Massachusetts, the City of Boston, Partners HealthCare, and the Boston Health Care for the Homeless Program.

Boston Hope is divided into a post-acute care section for recovering COVID-19 patients and a respite section for undomiciled patients with COVID-19 who need a place to safely quarantine. Built for a maximum of 1,000 beds, it is currently using fewer, with 83 patients on the post-acute side and 73 on the respite side as of May 12. A total of 370 and 315, respectively, had been admitted through May 12.

The team had 5 days to put the field hospital together with the help of the Army National Guard. “During that first week I was installing hand sanitizer dispensers and making [personal protective equipment] signs. Everyone here has had to do things like that,” Dr. Baughman said. “We’ve had to be incredibly creative in our staffing, using doctors from primary care and subspecialties including dermatology, radiology, and orthopedics. We had to fast-track trainings on how to use EPIC and to provide post-acute COVID care. How do you simultaneously build a medical facility and lead teams to provide high quality care?”

Dr. Baughman still works hospitalist shifts half-time at Massachusetts General. Her prior experience providing post-acute care in the VA system was helpful in creating the post-acute level of care at Boston Hope.

“My medical director role involves supervising, staffing, and scheduling. My co-medical director, Dr. Kerri Palamara, and I also supervise the clinical care,” she said. “There are a lot of systems issues, like ordering labs or prescriptions, with couriers going back and forth. And we developed clinical pathways, such as for [deep vein thrombosis] prophylaxis or for COVID retesting to determine when it is safe to end a quarantine. We’re just now rolling out virtual specialist consultations,” she noted.

Dr. Amy Baughman in personal protective equipment

“It has gone incredibly well. So much of it has been about our ability and willingness to work hard, and take feedback and go forward. We don’t have time to harp on things. We have to be very solution oriented. At the same time, honestly, it’s been fun. Every single day is different,” Dr. Baughman said.

“It’s been an opportunity to use my skills in a totally new setting, and at a level of responsibility I haven’t had before, although that’s probably a common theme with COVID-19. I was put on this team because I am a hospitalist,” she said. “I think hospitalists have been the backbone of the response to COVID in this country. It’s been an opportunity for our specialty to shine. We need to embrace the opportunity.”
 

Balancing expertise and supervision

Mount Sinai Hospital (MSH) in Manhattan is in the New York epicenter of the COVID-19 crisis and has mobilized large numbers of pulmonary critical care and anesthesia physicians to staff up multiple ICUs for COVID-19 patients, said Andrew Dunn, MD, chief of the division of hospital medicine at Mount Sinai School of Medicine.

Dr. Andrew Dunn

“My hospitalist group is covering many step-down units, medical wards, and atypical locations, providing advanced oxygen therapies, [bilevel positive airway pressure], high-flow nasal cannulas, and managing some patients on ventilators,” he said.

MSH has teaching services with house staff and nonteaching services. “We combined them into a unified service with house staff dispersed across all of the teams. We drafted a lot of nonhospitalists from different specialties to be attendings, and that has given us a tiered model, with a hospitalist supervising three or four nonhospitalist-led teams. Although the supervising hospitalists carry no patient caseloads of their own, this is primarily a clinical rather than an administrative role.”

At the peak, there were 40 rounding teams at MSH, each with a typical census of 15 patients or more, which meant that 10 supervisory hospitalists were responsible for 300 to 400 patients. “What we learned first was the need to balance the level of expertise. For example, a team may include a postgraduate year 3 resident and a radiology intern,” Dr. Dunn said. As COVID-19 census has started coming down, supervisory hospitalists are returning to direct care attending roles, and some hospitalists have been shared across the Mount Sinai system’s hospitals.

Dr. Dunn’s advice for hospitalists filling a supervisory role like this in a tiered model: Make sure you talk to your team the night before the first day of a scheduling block and try to address as many of their questions as possible. “If you wait until the morning of the shift to connect with them, anxiety will be high. But after going through a couple of scheduling cycles, we find that things are getting better. I think we’ve paid a lot of attention to the risks of burnout by our physicians. We’re using a model of 4 days on/4 off.”

Another variation on these themes is Joshua Shatzkes, MD, assistant professor of medicine and cardiology at Mount Sinai, who practices outpatient cardiology at MSH and in several off-site offices in Brooklyn. He saw early on that COVID-19 would have a huge effect on his practice, so he volunteered to help out with inpatient care. “I made it known to my chief that I was available, and I was deployed in the first week, after a weekend of cramming webinars and lectures on critical care and pulling out critical concepts that I already knew.”

Dr. Joshua Shatzkes

Dr. Shatzkes said his career path led him into outpatient cardiology 11 years ago, where he was quickly too busy to see his patients when they went into the hospital, even though he missed hospital medicine. Working as a temporary hospitalist with the arrival of COVID-19, he has been invigorated and mobilized by the experience and reminded of why he went to medical school in the first place. “Each day’s shift went quickly but felt long. At the end of the day, I was tired but not exhausted. When I walked out of a patient’s room, they could tell, ‘This is a doctor who cared for me,’ ” he said.

After Dr. Shatzkes volunteered, he got the call from his division chief. “I was officially deployed for a 4-day shift at Mount Sinai and then as a backup.” On his first morning as an inpatient doctor, he was still getting oriented when calls started coming from the nurses. “I had five patients struggling to breathe. Their degree of hypoxia was remarkable. I kept them out of the ICU, at least for that day.”

Since then, he has continued to follow some of those patients in the hospital, along with some from his outpatient practice who were hospitalized, and others referred by colleagues, while remaining available to his outpatients through telemedicine. When this is all over, Dr. Shatzkes said, he would love to find a way to incorporate a hospital practice in his job – depending on the realities of New York traffic.

“Joshua is not a hospitalist, but he went on service and felt so fulfilled and rewarded, he asked me if he could stay on service,” Dr. Dunn said. “I also got an email from the nurse manager on the unit. They want him back.”

In the midst of the COVID-19 pandemic, health systems, hospitals, and hospitalists – especially in hot spots like New York, Detroit, or Boston – have been challenged to stretch limits, redefine roles, and redeploy critical staff in response to rapidly changing needs on the ground.

Dr. Valerie Vaughn wearing personal protective equipment at Michigan Health

Many hospitalists are working above and beyond their normal duties, sometimes beyond their training, specialty, or comfort zone and are rising to the occasion in ways they never imagined. These include doing shifts in ICUs, working with ventilator patients, and reporting to other atypical sites of care like postanesthesia care units and post-acute or step-down units.

Valerie Vaughn, MD, MSc, a hospitalist with Michigan Medicine and assistant professor of medicine at the University of Michigan in Ann Arbor, was doing research on how to reduce overuse of antibiotics in hospitals when the COVID-19 crisis hit and dramatically redefined her job. “We were afraid that we might have 3,000 to 5,000 hospitalized COVID patients by now, based on predictive modeling done while the pandemic was still growing exponentially,” she explained. Although Michigan continues to have high COVID-19 infection rates, centered on nearby Detroit, “things are a lot better today than they were 4 weeks ago.”

Dr. Vaughn helped to mobilize a team of 25 hospitalists, along with other health care providers, who volunteered to manage COVID-19 patients in the ICU and other hospital units. She was asked to help develop an all-COVID unit called the Regional Infectious Containment Unit or RICU, which opened March 16. Then, when the RICU became full, it was supplemented by two COVID-19 Moderate Care Units staffed by hospitalists who had “learned the ropes” in the RICU.

Both of these new models were defined in relation to the ICUs at Michigan Medicine – which were doubling in capacity, up to 200 beds at last count – and to the provision of intensive-level and long-term ventilator care for the sickest patients. The moderate care units are for patients who are not on ventilators but still very sick, for example, those receiving massive high-flow oxygen, often with a medical do-not-resuscitate/do-not-intubate order. “We established these units to do everything (medically) short of vents,” Dr. Vaughn said.

“We are having in-depth conversations about goals of care with patients soon after they arrive at the hospital. We know outcomes from ventilators are worse for COVID-positive patients who have comorbidities, and we’re using that information to inform these conversations. We’ve given scripts to clinicians to help guide them in leading these conversations. We can do other things than `use ventilators to manage their symptoms. But these are still difficult conversations,” Dr. Vaughn said.

Boston Hope Medical Center

“We also engaged palliative care early on and asked them to round with us on every [COVID] patient – until demand got too high.” The bottleneck has been the number of ICU beds available, she explained. “If you want your patient to come in and take that bed, make sure you’ve talked to the family about it.”

The COVID-19 team developed guidelines printed on pocket cards addressing critical care issues such as a refresher on how to treat acute respiratory distress syndrome and how to use vasopressors. (See the COVID-19 Continuing Medical Education Portal for web-accessible educational resources developed by Michigan Health).

It’s amazing how quickly patients can become very sick with COVID-19, Dr. Vaughn said. “One of the good things to happen from the beginning with our RICU is that a group of doctors became COVID care experts very quickly. We joined four to five hospitalists and their teams with each intensivist, so one critical care expert is there to do teaching and answer clinicians’ questions. The hospitalists coordinate the COVID care and talk to the families.”

Working on the front lines of this crisis, Dr. Vaughn said, has generated a powerful sense of purpose and camaraderie, creating bonds like in war time. “All of us on our days off feel a twinge of guilt for not being there in the hospital. The sense of gratitude we get from patients and families has been enormous, even when we were telling them bad news. That just brings us to tears.”

One of the hardest things for the doctors practicing above their typical scope of practice is that, when something bad happens, they can’t know whether it was a mistake on their part or not, she noted. “But I’ve never been so proud of our group or to be a hospitalist. No one has complained or pushed back. Everyone has responded by saying: ‘What can I do to help?’ ”
 

 

 

Enough work in hospital medicine

Hospitalists had not been deployed to care for ICU patients at Beth Israel Deaconess Medical Center (BIDMC) in Boston, a major hot spot for COVID-19, said Joseph Ming Wah Li, MD, SFHM, director of the hospital medicine program at BIDMC, when he spoke to The Hospitalist in mid-May. That’s because there were plenty of hospital medicine assignments to keep them busy. Dr. Li leads a service of 120 hospitalists practicing at four hospitals.

“As we speak today, we have 300 patients with COVID, with 70 or 80 of them in our ICU. I’m taking care of 17 patients today, 15 of them COVID-positive, and the other two placed in a former radiology holding suite adapted for COVID-negative patients. Our postanesthesia care unit is now an ICU filled with COVID patients,” he said.

“Half of my day is seeing patients and the other half I’m on Zoom calls. I’m also one of the resource allocation officers for BIDMC,” Dr. Li said. He helped to create a standard of care for the hospital, addressing what to do if there weren’t enough ICU beds or ventilators. “We’ve never actualized it and probably won’t, but it was important to go through this exercise, with a lot of discussion up front.”

Dr. Haki Laho

Haki Laho, MD, an orthopedic hospitalist at New England Baptist Hospital (NEBH), also in Boston, has been redeployed to care for a different population of patients as his system tries to bunch patients. “All of a sudden – within hours and days – at the beginning of the pandemic and based on the recommendations, our whole system decided to stop all elective procedures and devote the resources to COVID,” he said.

NEBH is Beth Israel Lahey Health’s 141-bed orthopedic and surgical hospital, and the system has tried to keep the specialty facility COVID-19–free as much as possible, with the COVID-19 patients grouped together at BIDMC. Dr. Laho’s orthopedic hospitalist group, just five doctors, has been managing the influx of medical patients with multiple comorbidities – not COVID-19–infected but still a different kind of patient than they are used to.

“So far, so good. We’re dealing with it,” he said. “But if one of us got sick, the others would have to step up and do more shifts. We are physicians, internal medicine trained, but since my residency I hadn’t had to deal with these kinds of issues on a daily basis, such as setting up IV lines. I feel like I am back in residency mode.”
 

Convention Center medicine

Dr. Amy Baughman

Another Boston hospitalist, Amy Baughman, MD, who practices at Massachusetts General Hospital, is using her skills in a new setting, serving as a co-medical director at Boston Hope Medical Center, a 1,000-bed field hospital for patients with COVID-19. Open since April 10 and housed in the Boston Convention and Exhibition Center, it is a four-way collaboration between the Commonwealth of Massachusetts, the City of Boston, Partners HealthCare, and the Boston Health Care for the Homeless Program.

Boston Hope is divided into a post-acute care section for recovering COVID-19 patients and a respite section for undomiciled patients with COVID-19 who need a place to safely quarantine. Built for a maximum of 1,000 beds, it is currently using fewer, with 83 patients on the post-acute side and 73 on the respite side as of May 12. A total of 370 and 315, respectively, had been admitted through May 12.

The team had 5 days to put the field hospital together with the help of the Army National Guard. “During that first week I was installing hand sanitizer dispensers and making [personal protective equipment] signs. Everyone here has had to do things like that,” Dr. Baughman said. “We’ve had to be incredibly creative in our staffing, using doctors from primary care and subspecialties including dermatology, radiology, and orthopedics. We had to fast-track trainings on how to use EPIC and to provide post-acute COVID care. How do you simultaneously build a medical facility and lead teams to provide high quality care?”

Dr. Baughman still works hospitalist shifts half-time at Massachusetts General. Her prior experience providing post-acute care in the VA system was helpful in creating the post-acute level of care at Boston Hope.

“My medical director role involves supervising, staffing, and scheduling. My co-medical director, Dr. Kerri Palamara, and I also supervise the clinical care,” she said. “There are a lot of systems issues, like ordering labs or prescriptions, with couriers going back and forth. And we developed clinical pathways, such as for [deep vein thrombosis] prophylaxis or for COVID retesting to determine when it is safe to end a quarantine. We’re just now rolling out virtual specialist consultations,” she noted.

Dr. Amy Baughman in personal protective equipment

“It has gone incredibly well. So much of it has been about our ability and willingness to work hard, and take feedback and go forward. We don’t have time to harp on things. We have to be very solution oriented. At the same time, honestly, it’s been fun. Every single day is different,” Dr. Baughman said.

“It’s been an opportunity to use my skills in a totally new setting, and at a level of responsibility I haven’t had before, although that’s probably a common theme with COVID-19. I was put on this team because I am a hospitalist,” she said. “I think hospitalists have been the backbone of the response to COVID in this country. It’s been an opportunity for our specialty to shine. We need to embrace the opportunity.”
 

Balancing expertise and supervision

Mount Sinai Hospital (MSH) in Manhattan is in the New York epicenter of the COVID-19 crisis and has mobilized large numbers of pulmonary critical care and anesthesia physicians to staff up multiple ICUs for COVID-19 patients, said Andrew Dunn, MD, chief of the division of hospital medicine at Mount Sinai School of Medicine.

Dr. Andrew Dunn

“My hospitalist group is covering many step-down units, medical wards, and atypical locations, providing advanced oxygen therapies, [bilevel positive airway pressure], high-flow nasal cannulas, and managing some patients on ventilators,” he said.

MSH has teaching services with house staff and nonteaching services. “We combined them into a unified service with house staff dispersed across all of the teams. We drafted a lot of nonhospitalists from different specialties to be attendings, and that has given us a tiered model, with a hospitalist supervising three or four nonhospitalist-led teams. Although the supervising hospitalists carry no patient caseloads of their own, this is primarily a clinical rather than an administrative role.”

At the peak, there were 40 rounding teams at MSH, each with a typical census of 15 patients or more, which meant that 10 supervisory hospitalists were responsible for 300 to 400 patients. “What we learned first was the need to balance the level of expertise. For example, a team may include a postgraduate year 3 resident and a radiology intern,” Dr. Dunn said. As COVID-19 census has started coming down, supervisory hospitalists are returning to direct care attending roles, and some hospitalists have been shared across the Mount Sinai system’s hospitals.

Dr. Dunn’s advice for hospitalists filling a supervisory role like this in a tiered model: Make sure you talk to your team the night before the first day of a scheduling block and try to address as many of their questions as possible. “If you wait until the morning of the shift to connect with them, anxiety will be high. But after going through a couple of scheduling cycles, we find that things are getting better. I think we’ve paid a lot of attention to the risks of burnout by our physicians. We’re using a model of 4 days on/4 off.”

Another variation on these themes is Joshua Shatzkes, MD, assistant professor of medicine and cardiology at Mount Sinai, who practices outpatient cardiology at MSH and in several off-site offices in Brooklyn. He saw early on that COVID-19 would have a huge effect on his practice, so he volunteered to help out with inpatient care. “I made it known to my chief that I was available, and I was deployed in the first week, after a weekend of cramming webinars and lectures on critical care and pulling out critical concepts that I already knew.”

Dr. Joshua Shatzkes

Dr. Shatzkes said his career path led him into outpatient cardiology 11 years ago, where he was quickly too busy to see his patients when they went into the hospital, even though he missed hospital medicine. Working as a temporary hospitalist with the arrival of COVID-19, he has been invigorated and mobilized by the experience and reminded of why he went to medical school in the first place. “Each day’s shift went quickly but felt long. At the end of the day, I was tired but not exhausted. When I walked out of a patient’s room, they could tell, ‘This is a doctor who cared for me,’ ” he said.

After Dr. Shatzkes volunteered, he got the call from his division chief. “I was officially deployed for a 4-day shift at Mount Sinai and then as a backup.” On his first morning as an inpatient doctor, he was still getting oriented when calls started coming from the nurses. “I had five patients struggling to breathe. Their degree of hypoxia was remarkable. I kept them out of the ICU, at least for that day.”

Since then, he has continued to follow some of those patients in the hospital, along with some from his outpatient practice who were hospitalized, and others referred by colleagues, while remaining available to his outpatients through telemedicine. When this is all over, Dr. Shatzkes said, he would love to find a way to incorporate a hospital practice in his job – depending on the realities of New York traffic.

“Joshua is not a hospitalist, but he went on service and felt so fulfilled and rewarded, he asked me if he could stay on service,” Dr. Dunn said. “I also got an email from the nurse manager on the unit. They want him back.”

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Clinicians urged to use CURE ID to report COVID-19 cases

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Federal health officials are encouraging clinicians to use the free CURE ID mobile app and web platform as a tool to collect cases on the treatment of patients with COVID-19, in conjunction with ongoing clinical trial efforts.

“By utilizing the CURE ID platform now for COVID-19 case collection – in conjunction with data gathered from other registries, EHR systems, and clinical trials – data collected during an outbreak can be improved and coordinated,” Heather A. Stone, MPH, said during a June 9 webinar sponsored by the Food and Drug Administration. “This may allow us to find possible treatments to help ease this pandemic, and prepare us better to fight the next one.”

During the hour-long webinar, Ms. Stone, a health science policy analyst in the office of medical policy at the FDA’s Center for Drug Evaluation and Research, demonstrated CURE ID, an Internet-based data repository first developed in 2013 as a collaboration between the FDA and the National Center for Advancing Translational Sciences, a part of the National Institutes of Health (NCATS/NIH). It provides licensed clinicians worldwide with an opportunity to report novel uses of existing drugs for patients with difficult-to-treat infectious diseases, including COVID-19, through a website, a smartphone, or other mobile device. The app can be downloaded for free at http://cure.ncats.io. It can also be downloaded from the Apple app store or the Google Play store by searching “CURE ID.”

According to Ms. Stone, the platform’s three main goals are to enhance the understanding of new uses of approved medical products, to facilitate clinical trials and drug development, and to serve as a resource for physicians to share information where no FDA-approved product (which has been proven to be safe and effective) exists for the new use. CURE ID enables users to report their own cases as well as read cases of neglected infectious diseases with no sufficient approved therapies from other clinicians around the world. “It also enables clinicians to engage directly with communities of disease experts around the world, breaking down geographic and specialty silos,” Ms. Stone said. “It also enables them to access information on approved therapies for each disease and as well on active clinical trials.”



To date, CURE-ID contains information on 325 infectious diseases, including 1,580 case reports and 18,907 clinical trials. Initial pilot priority diseases include COVID-19, mycetoma, atypical mycobacteria, drug-resistant gonorrhea, rare and resistant fungal infections, as well as multidrug resistant gram-negative bacteria.

As of June 9, COVID-19-related data on the platform includes 151 case reports that have been extracted from the published literature or entered by clinician users, 80 discussion posts, and links to 694 clinical trials, 303 journal articles, 212 news articles, and 34 events. A total of 65 repurposed drugs have been identified as potential treatments for the virus, including 15 drugs with 10 or more cases.

“This facilitates clinicians reporting their real-world experiences treating COVID-19 patients, when patients are unable to be enrolled in a clinical trial,” Ms. Stone said. “It includes an updated case report form tailored to COVID-19 and data fields that have been harmonized with other real-world data and clinical trial platforms.” She pointed out that voluntary submission of cases to CURE ID is not a substitute for filing information with regulatory and public health authorities, where required. The platform also enables data to be entered and adverse events to be automatically shared with the FDA’s MedWatch Adverse Reporting System.

Ms. Stone concluded the webinar by announcing the formation of a new private-public partnership between the Critical Path Institute and the FDA and NCATS/NIH known as the CURE Drug Repurposing Collaboratory. The effort will begin with a pilot project focused on furthering drug development for COVID-19 through use of the CURE ID platform. “The Collaboratory will demonstrate how data shared from clinicians in real-time can be used to inform ongoing and future clinical trials, and potentially drug labeling,” Ms. Stone said. She reported having no financial disclosures.

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Federal health officials are encouraging clinicians to use the free CURE ID mobile app and web platform as a tool to collect cases on the treatment of patients with COVID-19, in conjunction with ongoing clinical trial efforts.

“By utilizing the CURE ID platform now for COVID-19 case collection – in conjunction with data gathered from other registries, EHR systems, and clinical trials – data collected during an outbreak can be improved and coordinated,” Heather A. Stone, MPH, said during a June 9 webinar sponsored by the Food and Drug Administration. “This may allow us to find possible treatments to help ease this pandemic, and prepare us better to fight the next one.”

During the hour-long webinar, Ms. Stone, a health science policy analyst in the office of medical policy at the FDA’s Center for Drug Evaluation and Research, demonstrated CURE ID, an Internet-based data repository first developed in 2013 as a collaboration between the FDA and the National Center for Advancing Translational Sciences, a part of the National Institutes of Health (NCATS/NIH). It provides licensed clinicians worldwide with an opportunity to report novel uses of existing drugs for patients with difficult-to-treat infectious diseases, including COVID-19, through a website, a smartphone, or other mobile device. The app can be downloaded for free at http://cure.ncats.io. It can also be downloaded from the Apple app store or the Google Play store by searching “CURE ID.”

According to Ms. Stone, the platform’s three main goals are to enhance the understanding of new uses of approved medical products, to facilitate clinical trials and drug development, and to serve as a resource for physicians to share information where no FDA-approved product (which has been proven to be safe and effective) exists for the new use. CURE ID enables users to report their own cases as well as read cases of neglected infectious diseases with no sufficient approved therapies from other clinicians around the world. “It also enables clinicians to engage directly with communities of disease experts around the world, breaking down geographic and specialty silos,” Ms. Stone said. “It also enables them to access information on approved therapies for each disease and as well on active clinical trials.”



To date, CURE-ID contains information on 325 infectious diseases, including 1,580 case reports and 18,907 clinical trials. Initial pilot priority diseases include COVID-19, mycetoma, atypical mycobacteria, drug-resistant gonorrhea, rare and resistant fungal infections, as well as multidrug resistant gram-negative bacteria.

As of June 9, COVID-19-related data on the platform includes 151 case reports that have been extracted from the published literature or entered by clinician users, 80 discussion posts, and links to 694 clinical trials, 303 journal articles, 212 news articles, and 34 events. A total of 65 repurposed drugs have been identified as potential treatments for the virus, including 15 drugs with 10 or more cases.

“This facilitates clinicians reporting their real-world experiences treating COVID-19 patients, when patients are unable to be enrolled in a clinical trial,” Ms. Stone said. “It includes an updated case report form tailored to COVID-19 and data fields that have been harmonized with other real-world data and clinical trial platforms.” She pointed out that voluntary submission of cases to CURE ID is not a substitute for filing information with regulatory and public health authorities, where required. The platform also enables data to be entered and adverse events to be automatically shared with the FDA’s MedWatch Adverse Reporting System.

Ms. Stone concluded the webinar by announcing the formation of a new private-public partnership between the Critical Path Institute and the FDA and NCATS/NIH known as the CURE Drug Repurposing Collaboratory. The effort will begin with a pilot project focused on furthering drug development for COVID-19 through use of the CURE ID platform. “The Collaboratory will demonstrate how data shared from clinicians in real-time can be used to inform ongoing and future clinical trials, and potentially drug labeling,” Ms. Stone said. She reported having no financial disclosures.

 

Federal health officials are encouraging clinicians to use the free CURE ID mobile app and web platform as a tool to collect cases on the treatment of patients with COVID-19, in conjunction with ongoing clinical trial efforts.

“By utilizing the CURE ID platform now for COVID-19 case collection – in conjunction with data gathered from other registries, EHR systems, and clinical trials – data collected during an outbreak can be improved and coordinated,” Heather A. Stone, MPH, said during a June 9 webinar sponsored by the Food and Drug Administration. “This may allow us to find possible treatments to help ease this pandemic, and prepare us better to fight the next one.”

During the hour-long webinar, Ms. Stone, a health science policy analyst in the office of medical policy at the FDA’s Center for Drug Evaluation and Research, demonstrated CURE ID, an Internet-based data repository first developed in 2013 as a collaboration between the FDA and the National Center for Advancing Translational Sciences, a part of the National Institutes of Health (NCATS/NIH). It provides licensed clinicians worldwide with an opportunity to report novel uses of existing drugs for patients with difficult-to-treat infectious diseases, including COVID-19, through a website, a smartphone, or other mobile device. The app can be downloaded for free at http://cure.ncats.io. It can also be downloaded from the Apple app store or the Google Play store by searching “CURE ID.”

According to Ms. Stone, the platform’s three main goals are to enhance the understanding of new uses of approved medical products, to facilitate clinical trials and drug development, and to serve as a resource for physicians to share information where no FDA-approved product (which has been proven to be safe and effective) exists for the new use. CURE ID enables users to report their own cases as well as read cases of neglected infectious diseases with no sufficient approved therapies from other clinicians around the world. “It also enables clinicians to engage directly with communities of disease experts around the world, breaking down geographic and specialty silos,” Ms. Stone said. “It also enables them to access information on approved therapies for each disease and as well on active clinical trials.”



To date, CURE-ID contains information on 325 infectious diseases, including 1,580 case reports and 18,907 clinical trials. Initial pilot priority diseases include COVID-19, mycetoma, atypical mycobacteria, drug-resistant gonorrhea, rare and resistant fungal infections, as well as multidrug resistant gram-negative bacteria.

As of June 9, COVID-19-related data on the platform includes 151 case reports that have been extracted from the published literature or entered by clinician users, 80 discussion posts, and links to 694 clinical trials, 303 journal articles, 212 news articles, and 34 events. A total of 65 repurposed drugs have been identified as potential treatments for the virus, including 15 drugs with 10 or more cases.

“This facilitates clinicians reporting their real-world experiences treating COVID-19 patients, when patients are unable to be enrolled in a clinical trial,” Ms. Stone said. “It includes an updated case report form tailored to COVID-19 and data fields that have been harmonized with other real-world data and clinical trial platforms.” She pointed out that voluntary submission of cases to CURE ID is not a substitute for filing information with regulatory and public health authorities, where required. The platform also enables data to be entered and adverse events to be automatically shared with the FDA’s MedWatch Adverse Reporting System.

Ms. Stone concluded the webinar by announcing the formation of a new private-public partnership between the Critical Path Institute and the FDA and NCATS/NIH known as the CURE Drug Repurposing Collaboratory. The effort will begin with a pilot project focused on furthering drug development for COVID-19 through use of the CURE ID platform. “The Collaboratory will demonstrate how data shared from clinicians in real-time can be used to inform ongoing and future clinical trials, and potentially drug labeling,” Ms. Stone said. She reported having no financial disclosures.

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EULAR’s COVID-19 recommendations offer no surprises

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As might be expected, the “EULAR [European League Against Rheumatism] provisional recommendations for the management of rheumatic and musculoskeletal diseases [RMDs] in the context of SARS-CoV-2” concur with much of the guidance already released on how best to manage patients during the current pandemic.

Dr. Robert Landewé

Highlights of the five overarching principles are that, contrary to earlier expectations, “there is no indication that patients with RMDs have an additional, or have a higher, risk of contracting the virus, or that they fare a worse course” than the general population, said the task force convener Robert Landewé, MD, PhD, professor of rheumatology at the University of Amsterdam.

“The second pertinent highlight is that, when it comes to managerial discussions, whether or not to stop or to start treatment for RMDs, rheumatologists should definitely be involved,” Dr. Landewé said during a live session at the annual European Congress of Rheumatology, held online this year due to COVID-19. “In practice, something that happens very often is that immunosuppressive drugs are stopped by medical specialists involved in the care of COVID but without any expertise in treating patients with rheumatic diseases. We should try to avoid that situation.”

The third highlight, something many rheumatologists may already be well aware of, is that rheumatology drugs are being used to treat COVID-19 patients without RMDs and a shortage of disease-modifying antirheumatic drugs (DMARDs) agents is a real possibility. As such, the fifth overarching highlight states that the availability of both synthetic and biologic DMARDs is “a delicate societal responsibility” and that “the off-label use of DMARDs in COVID-19 outside the context of clinical trials should be discouraged.”

The EULAR recommendation are now published online in Annals of the Rheumatic Diseases and they are “what you could call an unprecedented set of recommendations,” Dr. Landewé said. “We have never done this before,” he added, referring to the speed and way in which they had to be put together, remotely, and with little scientific evidence currently available. “Three months ago we hadn’t even heard about the virus.”



From the first patient being identified in the Hubei province of China in November 2019, to the first U.S. patient in the state of Washington on Jan. 20, 2020, and to the first European patient identified a little over 10 days later, the COVID-19 pandemic has taken the world by storm. It was only declared a pandemic on March 11, 2020, however, and Dr. Landewé noted that the response to the pandemic had been very variable – some countries locking down their borders early, while others took their time to make an appropriate response, if at all.

The rheumatology community was particularly concerned, Dr. Landewé said, because people with autoimmune diseases who were taking immunosuppressant drugs might be at higher risk for becoming infected with SARS-CoV-2, and may be at higher risk than others for a worse disease course. Thankfully, that seems not to be the case according to data that are emerging from new registries that have been set up, including EULAR’s own COVID-19 registry.

There are 13 recommendations that cover 4 themes: general measures and prevention of SARS-CoV-2 infection; the management of RMD patients during the pandemic; the management of RMD patients who have COVID-19; and the prevention of other pulmonary infections in RMD patients.

Highlighting the first three general recommendations, Dr. Landewé said: “Follow the regular guidelines in your country; if a patient with RMD does not have symptoms of COVID-19, simply continue RMD treatments,” albeit with a couple of exceptions.

The next four recommendation highlights are to avoid visits to the hospital or to the office; use remote monitoring via the telephone, for example; and if visits cannot be avoided, then take appropriate precautions. Finally, if you suspect a patient has COVID-19, do a test.

If patients test positive, then the next four recommendations cover what to do, such as continuing use of RMD treatments, but in the case of glucocorticoids this should be the lowest possible dose necessary. There is no consensus on what to do in cases of mild symptoms; the recommendation is to “decide on a case-by-case basis,” said Dr. Landewé. If a patient’s symptoms worsen, then “seek expert advice immediately and follow local treatment recommendations. The rheumatologist is not the expert to treat COVID-19,” he added. That responsibility lies with the pulmonologist, infectious disease specialist, or maybe the intensive care specialist, depending on local situations.

Dr. Ted Mikuls

On the whole, the EULAR recommendations are pretty similar to those already released by the American College of Rheumatology, said Ted Mikuls, MD, of the University of Nebraska Medical Center, Omaha. The ACR recommendations are “slightly more prescriptive”, he suggested, with 25 final guidance statements. For example, general statements focused not only on the use of glucocorticoids, but also other medicines, such as antihypertensives.

“There’s really not a [lot of], I would say, major differences in the two efforts and that’s ... somewhat reassuring that we’re approaching the unknown from very different parts of the world, and driving in a very similar place,” commented Dr. Mikuls, who is a member of the ACR COVID-19 recommendations task force.

“I think one of the very important similarities that I would highlight is that, in the absence of known exposure, in the absence of COVID-19 infection, our panel felt very strongly about the importance of continuing rheumatic disease treatments,” Dr. Mikuls observed. The ACR guidelines also touch upon societal perspectives, including “some statements that were made very specific to lupus, and the use of antimalarials, given supply chain issues that we have encountered.”

Dr. Mikuls also said that the American recommendations emphasized that “you really have to manage active inflammatory rheumatic disease. Even in the context of the COVID-19 pandemic, given what we saw as the potential risk of unchecked inflammation and unchecked rheumatic disease.”

One notable difference, however, is that the European recommendations advise on immunizations and pneumonia prophylaxis, saying that all patients without COVID-19 symptoms should make sure they are up to date with any recommended vaccinations, “with a particular focus on pneumococcal and influenza vaccinations,” Dr. Landewé said.

Another difference is that the ACR recommendations are a living document and could potentially be updated monthly if the evidence arrives to allow that. In that sense, the American guidance is more agile, with EULAR expecting to update its recommendations every 3 months.

“The current evidence is extremely sparse and fragmented,” Dr. Landewé said. “We, as a task force are essentially flying blindly. We also have to cover many jurisdictions within Europe, with many conflicting opinions. So the last word to say is that updates are truly necessary, but we have to wait a while.”

SOURCE: Landewé RB et al. Ann Rheum Dis. 2020 Jun 5. doi: 10.1136/annrheumdis-2020-217877.

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As might be expected, the “EULAR [European League Against Rheumatism] provisional recommendations for the management of rheumatic and musculoskeletal diseases [RMDs] in the context of SARS-CoV-2” concur with much of the guidance already released on how best to manage patients during the current pandemic.

Dr. Robert Landewé

Highlights of the five overarching principles are that, contrary to earlier expectations, “there is no indication that patients with RMDs have an additional, or have a higher, risk of contracting the virus, or that they fare a worse course” than the general population, said the task force convener Robert Landewé, MD, PhD, professor of rheumatology at the University of Amsterdam.

“The second pertinent highlight is that, when it comes to managerial discussions, whether or not to stop or to start treatment for RMDs, rheumatologists should definitely be involved,” Dr. Landewé said during a live session at the annual European Congress of Rheumatology, held online this year due to COVID-19. “In practice, something that happens very often is that immunosuppressive drugs are stopped by medical specialists involved in the care of COVID but without any expertise in treating patients with rheumatic diseases. We should try to avoid that situation.”

The third highlight, something many rheumatologists may already be well aware of, is that rheumatology drugs are being used to treat COVID-19 patients without RMDs and a shortage of disease-modifying antirheumatic drugs (DMARDs) agents is a real possibility. As such, the fifth overarching highlight states that the availability of both synthetic and biologic DMARDs is “a delicate societal responsibility” and that “the off-label use of DMARDs in COVID-19 outside the context of clinical trials should be discouraged.”

The EULAR recommendation are now published online in Annals of the Rheumatic Diseases and they are “what you could call an unprecedented set of recommendations,” Dr. Landewé said. “We have never done this before,” he added, referring to the speed and way in which they had to be put together, remotely, and with little scientific evidence currently available. “Three months ago we hadn’t even heard about the virus.”



From the first patient being identified in the Hubei province of China in November 2019, to the first U.S. patient in the state of Washington on Jan. 20, 2020, and to the first European patient identified a little over 10 days later, the COVID-19 pandemic has taken the world by storm. It was only declared a pandemic on March 11, 2020, however, and Dr. Landewé noted that the response to the pandemic had been very variable – some countries locking down their borders early, while others took their time to make an appropriate response, if at all.

The rheumatology community was particularly concerned, Dr. Landewé said, because people with autoimmune diseases who were taking immunosuppressant drugs might be at higher risk for becoming infected with SARS-CoV-2, and may be at higher risk than others for a worse disease course. Thankfully, that seems not to be the case according to data that are emerging from new registries that have been set up, including EULAR’s own COVID-19 registry.

There are 13 recommendations that cover 4 themes: general measures and prevention of SARS-CoV-2 infection; the management of RMD patients during the pandemic; the management of RMD patients who have COVID-19; and the prevention of other pulmonary infections in RMD patients.

Highlighting the first three general recommendations, Dr. Landewé said: “Follow the regular guidelines in your country; if a patient with RMD does not have symptoms of COVID-19, simply continue RMD treatments,” albeit with a couple of exceptions.

The next four recommendation highlights are to avoid visits to the hospital or to the office; use remote monitoring via the telephone, for example; and if visits cannot be avoided, then take appropriate precautions. Finally, if you suspect a patient has COVID-19, do a test.

If patients test positive, then the next four recommendations cover what to do, such as continuing use of RMD treatments, but in the case of glucocorticoids this should be the lowest possible dose necessary. There is no consensus on what to do in cases of mild symptoms; the recommendation is to “decide on a case-by-case basis,” said Dr. Landewé. If a patient’s symptoms worsen, then “seek expert advice immediately and follow local treatment recommendations. The rheumatologist is not the expert to treat COVID-19,” he added. That responsibility lies with the pulmonologist, infectious disease specialist, or maybe the intensive care specialist, depending on local situations.

Dr. Ted Mikuls

On the whole, the EULAR recommendations are pretty similar to those already released by the American College of Rheumatology, said Ted Mikuls, MD, of the University of Nebraska Medical Center, Omaha. The ACR recommendations are “slightly more prescriptive”, he suggested, with 25 final guidance statements. For example, general statements focused not only on the use of glucocorticoids, but also other medicines, such as antihypertensives.

“There’s really not a [lot of], I would say, major differences in the two efforts and that’s ... somewhat reassuring that we’re approaching the unknown from very different parts of the world, and driving in a very similar place,” commented Dr. Mikuls, who is a member of the ACR COVID-19 recommendations task force.

“I think one of the very important similarities that I would highlight is that, in the absence of known exposure, in the absence of COVID-19 infection, our panel felt very strongly about the importance of continuing rheumatic disease treatments,” Dr. Mikuls observed. The ACR guidelines also touch upon societal perspectives, including “some statements that were made very specific to lupus, and the use of antimalarials, given supply chain issues that we have encountered.”

Dr. Mikuls also said that the American recommendations emphasized that “you really have to manage active inflammatory rheumatic disease. Even in the context of the COVID-19 pandemic, given what we saw as the potential risk of unchecked inflammation and unchecked rheumatic disease.”

One notable difference, however, is that the European recommendations advise on immunizations and pneumonia prophylaxis, saying that all patients without COVID-19 symptoms should make sure they are up to date with any recommended vaccinations, “with a particular focus on pneumococcal and influenza vaccinations,” Dr. Landewé said.

Another difference is that the ACR recommendations are a living document and could potentially be updated monthly if the evidence arrives to allow that. In that sense, the American guidance is more agile, with EULAR expecting to update its recommendations every 3 months.

“The current evidence is extremely sparse and fragmented,” Dr. Landewé said. “We, as a task force are essentially flying blindly. We also have to cover many jurisdictions within Europe, with many conflicting opinions. So the last word to say is that updates are truly necessary, but we have to wait a while.”

SOURCE: Landewé RB et al. Ann Rheum Dis. 2020 Jun 5. doi: 10.1136/annrheumdis-2020-217877.

As might be expected, the “EULAR [European League Against Rheumatism] provisional recommendations for the management of rheumatic and musculoskeletal diseases [RMDs] in the context of SARS-CoV-2” concur with much of the guidance already released on how best to manage patients during the current pandemic.

Dr. Robert Landewé

Highlights of the five overarching principles are that, contrary to earlier expectations, “there is no indication that patients with RMDs have an additional, or have a higher, risk of contracting the virus, or that they fare a worse course” than the general population, said the task force convener Robert Landewé, MD, PhD, professor of rheumatology at the University of Amsterdam.

“The second pertinent highlight is that, when it comes to managerial discussions, whether or not to stop or to start treatment for RMDs, rheumatologists should definitely be involved,” Dr. Landewé said during a live session at the annual European Congress of Rheumatology, held online this year due to COVID-19. “In practice, something that happens very often is that immunosuppressive drugs are stopped by medical specialists involved in the care of COVID but without any expertise in treating patients with rheumatic diseases. We should try to avoid that situation.”

The third highlight, something many rheumatologists may already be well aware of, is that rheumatology drugs are being used to treat COVID-19 patients without RMDs and a shortage of disease-modifying antirheumatic drugs (DMARDs) agents is a real possibility. As such, the fifth overarching highlight states that the availability of both synthetic and biologic DMARDs is “a delicate societal responsibility” and that “the off-label use of DMARDs in COVID-19 outside the context of clinical trials should be discouraged.”

The EULAR recommendation are now published online in Annals of the Rheumatic Diseases and they are “what you could call an unprecedented set of recommendations,” Dr. Landewé said. “We have never done this before,” he added, referring to the speed and way in which they had to be put together, remotely, and with little scientific evidence currently available. “Three months ago we hadn’t even heard about the virus.”



From the first patient being identified in the Hubei province of China in November 2019, to the first U.S. patient in the state of Washington on Jan. 20, 2020, and to the first European patient identified a little over 10 days later, the COVID-19 pandemic has taken the world by storm. It was only declared a pandemic on March 11, 2020, however, and Dr. Landewé noted that the response to the pandemic had been very variable – some countries locking down their borders early, while others took their time to make an appropriate response, if at all.

The rheumatology community was particularly concerned, Dr. Landewé said, because people with autoimmune diseases who were taking immunosuppressant drugs might be at higher risk for becoming infected with SARS-CoV-2, and may be at higher risk than others for a worse disease course. Thankfully, that seems not to be the case according to data that are emerging from new registries that have been set up, including EULAR’s own COVID-19 registry.

There are 13 recommendations that cover 4 themes: general measures and prevention of SARS-CoV-2 infection; the management of RMD patients during the pandemic; the management of RMD patients who have COVID-19; and the prevention of other pulmonary infections in RMD patients.

Highlighting the first three general recommendations, Dr. Landewé said: “Follow the regular guidelines in your country; if a patient with RMD does not have symptoms of COVID-19, simply continue RMD treatments,” albeit with a couple of exceptions.

The next four recommendation highlights are to avoid visits to the hospital or to the office; use remote monitoring via the telephone, for example; and if visits cannot be avoided, then take appropriate precautions. Finally, if you suspect a patient has COVID-19, do a test.

If patients test positive, then the next four recommendations cover what to do, such as continuing use of RMD treatments, but in the case of glucocorticoids this should be the lowest possible dose necessary. There is no consensus on what to do in cases of mild symptoms; the recommendation is to “decide on a case-by-case basis,” said Dr. Landewé. If a patient’s symptoms worsen, then “seek expert advice immediately and follow local treatment recommendations. The rheumatologist is not the expert to treat COVID-19,” he added. That responsibility lies with the pulmonologist, infectious disease specialist, or maybe the intensive care specialist, depending on local situations.

Dr. Ted Mikuls

On the whole, the EULAR recommendations are pretty similar to those already released by the American College of Rheumatology, said Ted Mikuls, MD, of the University of Nebraska Medical Center, Omaha. The ACR recommendations are “slightly more prescriptive”, he suggested, with 25 final guidance statements. For example, general statements focused not only on the use of glucocorticoids, but also other medicines, such as antihypertensives.

“There’s really not a [lot of], I would say, major differences in the two efforts and that’s ... somewhat reassuring that we’re approaching the unknown from very different parts of the world, and driving in a very similar place,” commented Dr. Mikuls, who is a member of the ACR COVID-19 recommendations task force.

“I think one of the very important similarities that I would highlight is that, in the absence of known exposure, in the absence of COVID-19 infection, our panel felt very strongly about the importance of continuing rheumatic disease treatments,” Dr. Mikuls observed. The ACR guidelines also touch upon societal perspectives, including “some statements that were made very specific to lupus, and the use of antimalarials, given supply chain issues that we have encountered.”

Dr. Mikuls also said that the American recommendations emphasized that “you really have to manage active inflammatory rheumatic disease. Even in the context of the COVID-19 pandemic, given what we saw as the potential risk of unchecked inflammation and unchecked rheumatic disease.”

One notable difference, however, is that the European recommendations advise on immunizations and pneumonia prophylaxis, saying that all patients without COVID-19 symptoms should make sure they are up to date with any recommended vaccinations, “with a particular focus on pneumococcal and influenza vaccinations,” Dr. Landewé said.

Another difference is that the ACR recommendations are a living document and could potentially be updated monthly if the evidence arrives to allow that. In that sense, the American guidance is more agile, with EULAR expecting to update its recommendations every 3 months.

“The current evidence is extremely sparse and fragmented,” Dr. Landewé said. “We, as a task force are essentially flying blindly. We also have to cover many jurisdictions within Europe, with many conflicting opinions. So the last word to say is that updates are truly necessary, but we have to wait a while.”

SOURCE: Landewé RB et al. Ann Rheum Dis. 2020 Jun 5. doi: 10.1136/annrheumdis-2020-217877.

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TICOSPA: Efficacy of treat-to-target strategy suggested in axial spondyloarthritis

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A treat-to-target strategy for managing patients with axial spondyloarthritis failed to meet its primary efficacy endpoint but still showed several suggestive indications of benefit compared with usual care in a multicenter, randomized study with 160 patients.

The treat-to-target management strategy tested aimed to get patients to an Ankylosing Spondylitis Disease Activity Score (ASDAS) of less than 2.1, as recommended for patients with axial spondyloarthritis (axSpA) by an international task force. Also notable about the study was its primary endpoint, at least a 30% improvement in the Assessment of Spondyloarthritis International Society Health Index (ASAS HI), a measure of health-related quality-of-life that the study organizers selected in part because of its distinction from the treatment target.

Dr. Anna Moltó

“For the first time in rheumatology, we targeted inflammation to have an impact on another domain of the disease. Despite not reaching statistical significance, we see a difference between the groups,” Anna Moltó, MD, said at the annual European Congress of Rheumatology, held online this year due to COVID-19.

After 12 months in the study, the 80 axSpA patients assigned to the treat-to-target regimen had a 47% rate of attainment of the primary endpoint, compared with 36% of the 80 patients assigned to usual care, an 11% absolute between-group difference with a P value that came close to but failed to achieve the conventional standard of statistical significance after adjustment for potential confounders (P = .09). Six secondary outcomes showed statistically significant improvements compared with the control patients, including the Bath Ankylosing Spondylitis Disease Activity Index (BASDAI), the ASAS 20, and ASAS 40. Five additional metrics showed nominal between-group improvements with the treat-to-target strategy that were not statistically significant, including various forms of the ASDAS.



One additional notable finding came from a cost-efficacy analysis run by Dr. Moltó and associates, which showed that the treat-to-target strategy was “dominant” over usual care by producing both better outcomes as well as a lower total cost, compared with control patients, even though twice as many patients on the treat-to-target strategy received a biologic disease-modifying antirheumatic drug (bDMARD) compared with patients in the usual care group. The incremental cost utility ratio for treat-to-target was 19,430 euros (about $22,000) per quality-adjusted life-year gained, putting the strategy into the range of a “cost effective” approach, and the two treatment arms also had comparable safety, said Dr. Moltó, a rheumatologist at Cochin Hospital in Paris.

Dr. Maxime Dougados

The 11% increase in treat-to-target patients achieving at least a 30% improvement in their ASAS HI score “is potentially clinically relevant” because the comparator arm in the study received “very active” usual care and was not by any measure a true placebo control group, noted Maxime Dougados, MD, a rheumatologist and professor or medicine at Cochin Hospital and senior investigator for the study. In general, in treatment studies of rheumatologic diseases a 10% or greater absolute increase in the incidence of a beneficial outcome is considered clinically meaningful when compared with an actively-treated control arm, he noted.

Dr. Sofia Ramiro

“Using the ASAS HI score was very ambitious for the study, and it’s a very relevant outcome,” said Sofia Ramiro, MD, a rheumatologist at Leiden (the Netherlands) University Medical Center who was not associated with the study and chaired the session where Dr. Moltó gave her report. “We have had treat-to-target trials that showed benefit when disease activity was the endpoint.” But when a study “targets treatment to [reducing] disease activity and then uses disease activity as the outcome measure you expect to see an effect, but it is circular reasoning and we are left with challenges in interpreting the results. Now we have a trial that is formally [neutral] but with a different, more ambitious endpoint. All the indications are for benefit from treat-to-target for both the primary endpoint and for all the other endpoints.”

Dr. Désirée van der Heijde

“We were in a difficult situation when choosing the outcome. We didn’t know whether a 30% improvement in the ASAS HI was really relevant, but it seems to be,” said Désirée van der Heijde, MD, a rheumatologist and professor of medicine at Leiden University Medical Center and a collaborator on Dr. Moltó’s study. “I’d choose ASAS HI again as a primary endpoint” for a treat-to-target study in patients with axSpA, she said, but added that a 30% improvement in this score as the response threshold may warrant reconsideration. Both Dr. van der Heijde and Dr. Dougados agreed that at least one additional study with a somewhat similar design is needed to better document and confirm a role for a treat-to-target strategy in axSpA patients.

The Tight Control in Spondyloarthritis (TICOSPA) study ran at 10 French centers and 4 centers each in Belgium and the Netherlands. The study enrolled adults with rheumatologist-diagnosed axSpA with an ASDAS score greater than 2.1 who had not yet received a bDMARD, had not yet maxed out on their dosage of NSAIDs, and had certain baseline immunologic and imaging findings available. The researchers randomized 160 patients to either treat-to-target or usual care management by the center they attended to prevent cross contamination of management strategies. The treat-to-target regimen involved office examinations and consultations every 4 weeks rather than every 3 months with usual care, and also required a predefined management strategy with treatment prompts based on the strategy sent to the treating clinicians via the EMR. The average age of the patients was 38 years, they had been diagnosed with axSpA for an average of just under 4 years, and their mean ASDAS score at entry was 3. During the 12 months of management, 56% of the patients in the treat-to-target arm initiated treatment with a bDMARD, compared with 28% among the controls. Use of NSAIDs was similar between the two study subgroups.

TICOSPA was sponsored by UCB. Dr. Moltó has been a consultant to and received research funding from AbbVie, Bristol-Myers Squibb, Merck, Pfizer, and UCB. Dr. Dougados has had financial relationships with AbbVie, Bristol-Myers Squibb, Janssen, Lilly, Novartis, Merck, Pfizer, and UCB. Dr. van der Heijde has had financial relationships with more than 20 companies including UCB. Dr. Ramiro had been a consultant to or received research funding from AbbVie, Eli Lilly, Merck Sharp & Dohme, Novartis, and Sanofi.

SOURCE: Moltó A et al. Ann Rheum Dis. 2020 Jun;79[suppl 1]:413.

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A treat-to-target strategy for managing patients with axial spondyloarthritis failed to meet its primary efficacy endpoint but still showed several suggestive indications of benefit compared with usual care in a multicenter, randomized study with 160 patients.

The treat-to-target management strategy tested aimed to get patients to an Ankylosing Spondylitis Disease Activity Score (ASDAS) of less than 2.1, as recommended for patients with axial spondyloarthritis (axSpA) by an international task force. Also notable about the study was its primary endpoint, at least a 30% improvement in the Assessment of Spondyloarthritis International Society Health Index (ASAS HI), a measure of health-related quality-of-life that the study organizers selected in part because of its distinction from the treatment target.

Dr. Anna Moltó

“For the first time in rheumatology, we targeted inflammation to have an impact on another domain of the disease. Despite not reaching statistical significance, we see a difference between the groups,” Anna Moltó, MD, said at the annual European Congress of Rheumatology, held online this year due to COVID-19.

After 12 months in the study, the 80 axSpA patients assigned to the treat-to-target regimen had a 47% rate of attainment of the primary endpoint, compared with 36% of the 80 patients assigned to usual care, an 11% absolute between-group difference with a P value that came close to but failed to achieve the conventional standard of statistical significance after adjustment for potential confounders (P = .09). Six secondary outcomes showed statistically significant improvements compared with the control patients, including the Bath Ankylosing Spondylitis Disease Activity Index (BASDAI), the ASAS 20, and ASAS 40. Five additional metrics showed nominal between-group improvements with the treat-to-target strategy that were not statistically significant, including various forms of the ASDAS.



One additional notable finding came from a cost-efficacy analysis run by Dr. Moltó and associates, which showed that the treat-to-target strategy was “dominant” over usual care by producing both better outcomes as well as a lower total cost, compared with control patients, even though twice as many patients on the treat-to-target strategy received a biologic disease-modifying antirheumatic drug (bDMARD) compared with patients in the usual care group. The incremental cost utility ratio for treat-to-target was 19,430 euros (about $22,000) per quality-adjusted life-year gained, putting the strategy into the range of a “cost effective” approach, and the two treatment arms also had comparable safety, said Dr. Moltó, a rheumatologist at Cochin Hospital in Paris.

Dr. Maxime Dougados

The 11% increase in treat-to-target patients achieving at least a 30% improvement in their ASAS HI score “is potentially clinically relevant” because the comparator arm in the study received “very active” usual care and was not by any measure a true placebo control group, noted Maxime Dougados, MD, a rheumatologist and professor or medicine at Cochin Hospital and senior investigator for the study. In general, in treatment studies of rheumatologic diseases a 10% or greater absolute increase in the incidence of a beneficial outcome is considered clinically meaningful when compared with an actively-treated control arm, he noted.

Dr. Sofia Ramiro

“Using the ASAS HI score was very ambitious for the study, and it’s a very relevant outcome,” said Sofia Ramiro, MD, a rheumatologist at Leiden (the Netherlands) University Medical Center who was not associated with the study and chaired the session where Dr. Moltó gave her report. “We have had treat-to-target trials that showed benefit when disease activity was the endpoint.” But when a study “targets treatment to [reducing] disease activity and then uses disease activity as the outcome measure you expect to see an effect, but it is circular reasoning and we are left with challenges in interpreting the results. Now we have a trial that is formally [neutral] but with a different, more ambitious endpoint. All the indications are for benefit from treat-to-target for both the primary endpoint and for all the other endpoints.”

Dr. Désirée van der Heijde

“We were in a difficult situation when choosing the outcome. We didn’t know whether a 30% improvement in the ASAS HI was really relevant, but it seems to be,” said Désirée van der Heijde, MD, a rheumatologist and professor of medicine at Leiden University Medical Center and a collaborator on Dr. Moltó’s study. “I’d choose ASAS HI again as a primary endpoint” for a treat-to-target study in patients with axSpA, she said, but added that a 30% improvement in this score as the response threshold may warrant reconsideration. Both Dr. van der Heijde and Dr. Dougados agreed that at least one additional study with a somewhat similar design is needed to better document and confirm a role for a treat-to-target strategy in axSpA patients.

The Tight Control in Spondyloarthritis (TICOSPA) study ran at 10 French centers and 4 centers each in Belgium and the Netherlands. The study enrolled adults with rheumatologist-diagnosed axSpA with an ASDAS score greater than 2.1 who had not yet received a bDMARD, had not yet maxed out on their dosage of NSAIDs, and had certain baseline immunologic and imaging findings available. The researchers randomized 160 patients to either treat-to-target or usual care management by the center they attended to prevent cross contamination of management strategies. The treat-to-target regimen involved office examinations and consultations every 4 weeks rather than every 3 months with usual care, and also required a predefined management strategy with treatment prompts based on the strategy sent to the treating clinicians via the EMR. The average age of the patients was 38 years, they had been diagnosed with axSpA for an average of just under 4 years, and their mean ASDAS score at entry was 3. During the 12 months of management, 56% of the patients in the treat-to-target arm initiated treatment with a bDMARD, compared with 28% among the controls. Use of NSAIDs was similar between the two study subgroups.

TICOSPA was sponsored by UCB. Dr. Moltó has been a consultant to and received research funding from AbbVie, Bristol-Myers Squibb, Merck, Pfizer, and UCB. Dr. Dougados has had financial relationships with AbbVie, Bristol-Myers Squibb, Janssen, Lilly, Novartis, Merck, Pfizer, and UCB. Dr. van der Heijde has had financial relationships with more than 20 companies including UCB. Dr. Ramiro had been a consultant to or received research funding from AbbVie, Eli Lilly, Merck Sharp & Dohme, Novartis, and Sanofi.

SOURCE: Moltó A et al. Ann Rheum Dis. 2020 Jun;79[suppl 1]:413.

A treat-to-target strategy for managing patients with axial spondyloarthritis failed to meet its primary efficacy endpoint but still showed several suggestive indications of benefit compared with usual care in a multicenter, randomized study with 160 patients.

The treat-to-target management strategy tested aimed to get patients to an Ankylosing Spondylitis Disease Activity Score (ASDAS) of less than 2.1, as recommended for patients with axial spondyloarthritis (axSpA) by an international task force. Also notable about the study was its primary endpoint, at least a 30% improvement in the Assessment of Spondyloarthritis International Society Health Index (ASAS HI), a measure of health-related quality-of-life that the study organizers selected in part because of its distinction from the treatment target.

Dr. Anna Moltó

“For the first time in rheumatology, we targeted inflammation to have an impact on another domain of the disease. Despite not reaching statistical significance, we see a difference between the groups,” Anna Moltó, MD, said at the annual European Congress of Rheumatology, held online this year due to COVID-19.

After 12 months in the study, the 80 axSpA patients assigned to the treat-to-target regimen had a 47% rate of attainment of the primary endpoint, compared with 36% of the 80 patients assigned to usual care, an 11% absolute between-group difference with a P value that came close to but failed to achieve the conventional standard of statistical significance after adjustment for potential confounders (P = .09). Six secondary outcomes showed statistically significant improvements compared with the control patients, including the Bath Ankylosing Spondylitis Disease Activity Index (BASDAI), the ASAS 20, and ASAS 40. Five additional metrics showed nominal between-group improvements with the treat-to-target strategy that were not statistically significant, including various forms of the ASDAS.



One additional notable finding came from a cost-efficacy analysis run by Dr. Moltó and associates, which showed that the treat-to-target strategy was “dominant” over usual care by producing both better outcomes as well as a lower total cost, compared with control patients, even though twice as many patients on the treat-to-target strategy received a biologic disease-modifying antirheumatic drug (bDMARD) compared with patients in the usual care group. The incremental cost utility ratio for treat-to-target was 19,430 euros (about $22,000) per quality-adjusted life-year gained, putting the strategy into the range of a “cost effective” approach, and the two treatment arms also had comparable safety, said Dr. Moltó, a rheumatologist at Cochin Hospital in Paris.

Dr. Maxime Dougados

The 11% increase in treat-to-target patients achieving at least a 30% improvement in their ASAS HI score “is potentially clinically relevant” because the comparator arm in the study received “very active” usual care and was not by any measure a true placebo control group, noted Maxime Dougados, MD, a rheumatologist and professor or medicine at Cochin Hospital and senior investigator for the study. In general, in treatment studies of rheumatologic diseases a 10% or greater absolute increase in the incidence of a beneficial outcome is considered clinically meaningful when compared with an actively-treated control arm, he noted.

Dr. Sofia Ramiro

“Using the ASAS HI score was very ambitious for the study, and it’s a very relevant outcome,” said Sofia Ramiro, MD, a rheumatologist at Leiden (the Netherlands) University Medical Center who was not associated with the study and chaired the session where Dr. Moltó gave her report. “We have had treat-to-target trials that showed benefit when disease activity was the endpoint.” But when a study “targets treatment to [reducing] disease activity and then uses disease activity as the outcome measure you expect to see an effect, but it is circular reasoning and we are left with challenges in interpreting the results. Now we have a trial that is formally [neutral] but with a different, more ambitious endpoint. All the indications are for benefit from treat-to-target for both the primary endpoint and for all the other endpoints.”

Dr. Désirée van der Heijde

“We were in a difficult situation when choosing the outcome. We didn’t know whether a 30% improvement in the ASAS HI was really relevant, but it seems to be,” said Désirée van der Heijde, MD, a rheumatologist and professor of medicine at Leiden University Medical Center and a collaborator on Dr. Moltó’s study. “I’d choose ASAS HI again as a primary endpoint” for a treat-to-target study in patients with axSpA, she said, but added that a 30% improvement in this score as the response threshold may warrant reconsideration. Both Dr. van der Heijde and Dr. Dougados agreed that at least one additional study with a somewhat similar design is needed to better document and confirm a role for a treat-to-target strategy in axSpA patients.

The Tight Control in Spondyloarthritis (TICOSPA) study ran at 10 French centers and 4 centers each in Belgium and the Netherlands. The study enrolled adults with rheumatologist-diagnosed axSpA with an ASDAS score greater than 2.1 who had not yet received a bDMARD, had not yet maxed out on their dosage of NSAIDs, and had certain baseline immunologic and imaging findings available. The researchers randomized 160 patients to either treat-to-target or usual care management by the center they attended to prevent cross contamination of management strategies. The treat-to-target regimen involved office examinations and consultations every 4 weeks rather than every 3 months with usual care, and also required a predefined management strategy with treatment prompts based on the strategy sent to the treating clinicians via the EMR. The average age of the patients was 38 years, they had been diagnosed with axSpA for an average of just under 4 years, and their mean ASDAS score at entry was 3. During the 12 months of management, 56% of the patients in the treat-to-target arm initiated treatment with a bDMARD, compared with 28% among the controls. Use of NSAIDs was similar between the two study subgroups.

TICOSPA was sponsored by UCB. Dr. Moltó has been a consultant to and received research funding from AbbVie, Bristol-Myers Squibb, Merck, Pfizer, and UCB. Dr. Dougados has had financial relationships with AbbVie, Bristol-Myers Squibb, Janssen, Lilly, Novartis, Merck, Pfizer, and UCB. Dr. van der Heijde has had financial relationships with more than 20 companies including UCB. Dr. Ramiro had been a consultant to or received research funding from AbbVie, Eli Lilly, Merck Sharp & Dohme, Novartis, and Sanofi.

SOURCE: Moltó A et al. Ann Rheum Dis. 2020 Jun;79[suppl 1]:413.

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