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News and Views that Matter to Rheumatologists
gambling
compulsive behaviors
ammunition
assault rifle
black jack
Boko Haram
bondage
child abuse
cocaine
Daech
drug paraphernalia
explosion
gun
human trafficking
ISIL
ISIS
Islamic caliphate
Islamic state
mixed martial arts
MMA
molestation
national rifle association
NRA
nsfw
pedophile
pedophilia
poker
porn
pornography
psychedelic drug
recreational drug
sex slave rings
slot machine
terrorism
terrorist
Texas hold 'em
UFC
substance abuse
abuseed
abuseer
abusees
abuseing
abusely
abuses
aeolus
aeolused
aeoluser
aeoluses
aeolusing
aeolusly
aeoluss
ahole
aholeed
aholeer
aholees
aholeing
aholely
aholes
alcohol
alcoholed
alcoholer
alcoholes
alcoholing
alcoholly
alcohols
allman
allmaned
allmaner
allmanes
allmaning
allmanly
allmans
alted
altes
alting
altly
alts
analed
analer
anales
analing
anally
analprobe
analprobeed
analprobeer
analprobees
analprobeing
analprobely
analprobes
anals
anilingus
anilingused
anilinguser
anilinguses
anilingusing
anilingusly
anilinguss
anus
anused
anuser
anuses
anusing
anusly
anuss
areola
areolaed
areolaer
areolaes
areolaing
areolaly
areolas
areole
areoleed
areoleer
areolees
areoleing
areolely
areoles
arian
arianed
arianer
arianes
arianing
arianly
arians
aryan
aryaned
aryaner
aryanes
aryaning
aryanly
aryans
asiaed
asiaer
asiaes
asiaing
asialy
asias
ass
ass hole
ass lick
ass licked
ass licker
ass lickes
ass licking
ass lickly
ass licks
assbang
assbanged
assbangeded
assbangeder
assbangedes
assbangeding
assbangedly
assbangeds
assbanger
assbanges
assbanging
assbangly
assbangs
assbangsed
assbangser
assbangses
assbangsing
assbangsly
assbangss
assed
asser
asses
assesed
asseser
asseses
assesing
assesly
assess
assfuck
assfucked
assfucker
assfuckered
assfuckerer
assfuckeres
assfuckering
assfuckerly
assfuckers
assfuckes
assfucking
assfuckly
assfucks
asshat
asshated
asshater
asshates
asshating
asshatly
asshats
assholeed
assholeer
assholees
assholeing
assholely
assholes
assholesed
assholeser
assholeses
assholesing
assholesly
assholess
assing
assly
assmaster
assmastered
assmasterer
assmasteres
assmastering
assmasterly
assmasters
assmunch
assmunched
assmuncher
assmunches
assmunching
assmunchly
assmunchs
asss
asswipe
asswipeed
asswipeer
asswipees
asswipeing
asswipely
asswipes
asswipesed
asswipeser
asswipeses
asswipesing
asswipesly
asswipess
azz
azzed
azzer
azzes
azzing
azzly
azzs
babeed
babeer
babees
babeing
babely
babes
babesed
babeser
babeses
babesing
babesly
babess
ballsac
ballsaced
ballsacer
ballsaces
ballsacing
ballsack
ballsacked
ballsacker
ballsackes
ballsacking
ballsackly
ballsacks
ballsacly
ballsacs
ballsed
ballser
ballses
ballsing
ballsly
ballss
barf
barfed
barfer
barfes
barfing
barfly
barfs
bastard
bastarded
bastarder
bastardes
bastarding
bastardly
bastards
bastardsed
bastardser
bastardses
bastardsing
bastardsly
bastardss
bawdy
bawdyed
bawdyer
bawdyes
bawdying
bawdyly
bawdys
beaner
beanered
beanerer
beaneres
beanering
beanerly
beaners
beardedclam
beardedclamed
beardedclamer
beardedclames
beardedclaming
beardedclamly
beardedclams
beastiality
beastialityed
beastialityer
beastialityes
beastialitying
beastialityly
beastialitys
beatch
beatched
beatcher
beatches
beatching
beatchly
beatchs
beater
beatered
beaterer
beateres
beatering
beaterly
beaters
beered
beerer
beeres
beering
beerly
beeyotch
beeyotched
beeyotcher
beeyotches
beeyotching
beeyotchly
beeyotchs
beotch
beotched
beotcher
beotches
beotching
beotchly
beotchs
biatch
biatched
biatcher
biatches
biatching
biatchly
biatchs
big tits
big titsed
big titser
big titses
big titsing
big titsly
big titss
bigtits
bigtitsed
bigtitser
bigtitses
bigtitsing
bigtitsly
bigtitss
bimbo
bimboed
bimboer
bimboes
bimboing
bimboly
bimbos
bisexualed
bisexualer
bisexuales
bisexualing
bisexually
bisexuals
bitch
bitched
bitcheded
bitcheder
bitchedes
bitcheding
bitchedly
bitcheds
bitcher
bitches
bitchesed
bitcheser
bitcheses
bitchesing
bitchesly
bitchess
bitching
bitchly
bitchs
bitchy
bitchyed
bitchyer
bitchyes
bitchying
bitchyly
bitchys
bleached
bleacher
bleaches
bleaching
bleachly
bleachs
blow job
blow jobed
blow jober
blow jobes
blow jobing
blow jobly
blow jobs
blowed
blower
blowes
blowing
blowjob
blowjobed
blowjober
blowjobes
blowjobing
blowjobly
blowjobs
blowjobsed
blowjobser
blowjobses
blowjobsing
blowjobsly
blowjobss
blowly
blows
boink
boinked
boinker
boinkes
boinking
boinkly
boinks
bollock
bollocked
bollocker
bollockes
bollocking
bollockly
bollocks
bollocksed
bollockser
bollockses
bollocksing
bollocksly
bollockss
bollok
bolloked
bolloker
bollokes
bolloking
bollokly
bolloks
boner
bonered
bonerer
boneres
bonering
bonerly
boners
bonersed
bonerser
bonerses
bonersing
bonersly
bonerss
bong
bonged
bonger
bonges
bonging
bongly
bongs
boob
boobed
boober
boobes
boobies
boobiesed
boobieser
boobieses
boobiesing
boobiesly
boobiess
boobing
boobly
boobs
boobsed
boobser
boobses
boobsing
boobsly
boobss
booby
boobyed
boobyer
boobyes
boobying
boobyly
boobys
booger
boogered
boogerer
boogeres
boogering
boogerly
boogers
bookie
bookieed
bookieer
bookiees
bookieing
bookiely
bookies
bootee
booteeed
booteeer
booteees
booteeing
booteely
bootees
bootie
bootieed
bootieer
bootiees
bootieing
bootiely
booties
booty
bootyed
bootyer
bootyes
bootying
bootyly
bootys
boozeed
boozeer
boozees
boozeing
boozely
boozer
boozered
boozerer
boozeres
boozering
boozerly
boozers
boozes
boozy
boozyed
boozyer
boozyes
boozying
boozyly
boozys
bosomed
bosomer
bosomes
bosoming
bosomly
bosoms
bosomy
bosomyed
bosomyer
bosomyes
bosomying
bosomyly
bosomys
bugger
buggered
buggerer
buggeres
buggering
buggerly
buggers
bukkake
bukkakeed
bukkakeer
bukkakees
bukkakeing
bukkakely
bukkakes
bull shit
bull shited
bull shiter
bull shites
bull shiting
bull shitly
bull shits
bullshit
bullshited
bullshiter
bullshites
bullshiting
bullshitly
bullshits
bullshitsed
bullshitser
bullshitses
bullshitsing
bullshitsly
bullshitss
bullshitted
bullshitteded
bullshitteder
bullshittedes
bullshitteding
bullshittedly
bullshitteds
bullturds
bullturdsed
bullturdser
bullturdses
bullturdsing
bullturdsly
bullturdss
bung
bunged
bunger
bunges
bunging
bungly
bungs
busty
bustyed
bustyer
bustyes
bustying
bustyly
bustys
butt
butt fuck
butt fucked
butt fucker
butt fuckes
butt fucking
butt fuckly
butt fucks
butted
buttes
buttfuck
buttfucked
buttfucker
buttfuckered
buttfuckerer
buttfuckeres
buttfuckering
buttfuckerly
buttfuckers
buttfuckes
buttfucking
buttfuckly
buttfucks
butting
buttly
buttplug
buttpluged
buttpluger
buttpluges
buttpluging
buttplugly
buttplugs
butts
caca
cacaed
cacaer
cacaes
cacaing
cacaly
cacas
cahone
cahoneed
cahoneer
cahonees
cahoneing
cahonely
cahones
cameltoe
cameltoeed
cameltoeer
cameltoees
cameltoeing
cameltoely
cameltoes
carpetmuncher
carpetmunchered
carpetmuncherer
carpetmuncheres
carpetmunchering
carpetmuncherly
carpetmunchers
cawk
cawked
cawker
cawkes
cawking
cawkly
cawks
chinc
chinced
chincer
chinces
chincing
chincly
chincs
chincsed
chincser
chincses
chincsing
chincsly
chincss
chink
chinked
chinker
chinkes
chinking
chinkly
chinks
chode
chodeed
chodeer
chodees
chodeing
chodely
chodes
chodesed
chodeser
chodeses
chodesing
chodesly
chodess
clit
clited
cliter
clites
cliting
clitly
clitoris
clitorised
clitoriser
clitorises
clitorising
clitorisly
clitoriss
clitorus
clitorused
clitoruser
clitoruses
clitorusing
clitorusly
clitoruss
clits
clitsed
clitser
clitses
clitsing
clitsly
clitss
clitty
clittyed
clittyer
clittyes
clittying
clittyly
clittys
cocain
cocaine
cocained
cocaineed
cocaineer
cocainees
cocaineing
cocainely
cocainer
cocaines
cocaining
cocainly
cocains
cock
cock sucker
cock suckered
cock suckerer
cock suckeres
cock suckering
cock suckerly
cock suckers
cockblock
cockblocked
cockblocker
cockblockes
cockblocking
cockblockly
cockblocks
cocked
cocker
cockes
cockholster
cockholstered
cockholsterer
cockholsteres
cockholstering
cockholsterly
cockholsters
cocking
cockknocker
cockknockered
cockknockerer
cockknockeres
cockknockering
cockknockerly
cockknockers
cockly
cocks
cocksed
cockser
cockses
cocksing
cocksly
cocksmoker
cocksmokered
cocksmokerer
cocksmokeres
cocksmokering
cocksmokerly
cocksmokers
cockss
cocksucker
cocksuckered
cocksuckerer
cocksuckeres
cocksuckering
cocksuckerly
cocksuckers
coital
coitaled
coitaler
coitales
coitaling
coitally
coitals
commie
commieed
commieer
commiees
commieing
commiely
commies
condomed
condomer
condomes
condoming
condomly
condoms
coon
cooned
cooner
coones
cooning
coonly
coons
coonsed
coonser
coonses
coonsing
coonsly
coonss
corksucker
corksuckered
corksuckerer
corksuckeres
corksuckering
corksuckerly
corksuckers
cracked
crackwhore
crackwhoreed
crackwhoreer
crackwhorees
crackwhoreing
crackwhorely
crackwhores
crap
craped
craper
crapes
craping
craply
crappy
crappyed
crappyer
crappyes
crappying
crappyly
crappys
cum
cumed
cumer
cumes
cuming
cumly
cummin
cummined
cumminer
cummines
cumming
cumminged
cumminger
cumminges
cumminging
cummingly
cummings
cummining
cumminly
cummins
cums
cumshot
cumshoted
cumshoter
cumshotes
cumshoting
cumshotly
cumshots
cumshotsed
cumshotser
cumshotses
cumshotsing
cumshotsly
cumshotss
cumslut
cumsluted
cumsluter
cumslutes
cumsluting
cumslutly
cumsluts
cumstain
cumstained
cumstainer
cumstaines
cumstaining
cumstainly
cumstains
cunilingus
cunilingused
cunilinguser
cunilinguses
cunilingusing
cunilingusly
cunilinguss
cunnilingus
cunnilingused
cunnilinguser
cunnilinguses
cunnilingusing
cunnilingusly
cunnilinguss
cunny
cunnyed
cunnyer
cunnyes
cunnying
cunnyly
cunnys
cunt
cunted
cunter
cuntes
cuntface
cuntfaceed
cuntfaceer
cuntfacees
cuntfaceing
cuntfacely
cuntfaces
cunthunter
cunthuntered
cunthunterer
cunthunteres
cunthuntering
cunthunterly
cunthunters
cunting
cuntlick
cuntlicked
cuntlicker
cuntlickered
cuntlickerer
cuntlickeres
cuntlickering
cuntlickerly
cuntlickers
cuntlickes
cuntlicking
cuntlickly
cuntlicks
cuntly
cunts
cuntsed
cuntser
cuntses
cuntsing
cuntsly
cuntss
dago
dagoed
dagoer
dagoes
dagoing
dagoly
dagos
dagosed
dagoser
dagoses
dagosing
dagosly
dagoss
dammit
dammited
dammiter
dammites
dammiting
dammitly
dammits
damn
damned
damneded
damneder
damnedes
damneding
damnedly
damneds
damner
damnes
damning
damnit
damnited
damniter
damnites
damniting
damnitly
damnits
damnly
damns
dick
dickbag
dickbaged
dickbager
dickbages
dickbaging
dickbagly
dickbags
dickdipper
dickdippered
dickdipperer
dickdipperes
dickdippering
dickdipperly
dickdippers
dicked
dicker
dickes
dickface
dickfaceed
dickfaceer
dickfacees
dickfaceing
dickfacely
dickfaces
dickflipper
dickflippered
dickflipperer
dickflipperes
dickflippering
dickflipperly
dickflippers
dickhead
dickheaded
dickheader
dickheades
dickheading
dickheadly
dickheads
dickheadsed
dickheadser
dickheadses
dickheadsing
dickheadsly
dickheadss
dicking
dickish
dickished
dickisher
dickishes
dickishing
dickishly
dickishs
dickly
dickripper
dickrippered
dickripperer
dickripperes
dickrippering
dickripperly
dickrippers
dicks
dicksipper
dicksippered
dicksipperer
dicksipperes
dicksippering
dicksipperly
dicksippers
dickweed
dickweeded
dickweeder
dickweedes
dickweeding
dickweedly
dickweeds
dickwhipper
dickwhippered
dickwhipperer
dickwhipperes
dickwhippering
dickwhipperly
dickwhippers
dickzipper
dickzippered
dickzipperer
dickzipperes
dickzippering
dickzipperly
dickzippers
diddle
diddleed
diddleer
diddlees
diddleing
diddlely
diddles
dike
dikeed
dikeer
dikees
dikeing
dikely
dikes
dildo
dildoed
dildoer
dildoes
dildoing
dildoly
dildos
dildosed
dildoser
dildoses
dildosing
dildosly
dildoss
diligaf
diligafed
diligafer
diligafes
diligafing
diligafly
diligafs
dillweed
dillweeded
dillweeder
dillweedes
dillweeding
dillweedly
dillweeds
dimwit
dimwited
dimwiter
dimwites
dimwiting
dimwitly
dimwits
dingle
dingleed
dingleer
dinglees
dingleing
dinglely
dingles
dipship
dipshiped
dipshiper
dipshipes
dipshiping
dipshiply
dipships
dizzyed
dizzyer
dizzyes
dizzying
dizzyly
dizzys
doggiestyleed
doggiestyleer
doggiestylees
doggiestyleing
doggiestylely
doggiestyles
doggystyleed
doggystyleer
doggystylees
doggystyleing
doggystylely
doggystyles
dong
donged
donger
donges
donging
dongly
dongs
doofus
doofused
doofuser
doofuses
doofusing
doofusly
doofuss
doosh
dooshed
doosher
dooshes
dooshing
dooshly
dooshs
dopeyed
dopeyer
dopeyes
dopeying
dopeyly
dopeys
douchebag
douchebaged
douchebager
douchebages
douchebaging
douchebagly
douchebags
douchebagsed
douchebagser
douchebagses
douchebagsing
douchebagsly
douchebagss
doucheed
doucheer
douchees
doucheing
douchely
douches
douchey
doucheyed
doucheyer
doucheyes
doucheying
doucheyly
doucheys
drunk
drunked
drunker
drunkes
drunking
drunkly
drunks
dumass
dumassed
dumasser
dumasses
dumassing
dumassly
dumasss
dumbass
dumbassed
dumbasser
dumbasses
dumbassesed
dumbasseser
dumbasseses
dumbassesing
dumbassesly
dumbassess
dumbassing
dumbassly
dumbasss
dummy
dummyed
dummyer
dummyes
dummying
dummyly
dummys
dyke
dykeed
dykeer
dykees
dykeing
dykely
dykes
dykesed
dykeser
dykeses
dykesing
dykesly
dykess
erotic
eroticed
eroticer
erotices
eroticing
eroticly
erotics
extacy
extacyed
extacyer
extacyes
extacying
extacyly
extacys
extasy
extasyed
extasyer
extasyes
extasying
extasyly
extasys
fack
facked
facker
fackes
facking
fackly
facks
fag
faged
fager
fages
fagg
fagged
faggeded
faggeder
faggedes
faggeding
faggedly
faggeds
fagger
fagges
fagging
faggit
faggited
faggiter
faggites
faggiting
faggitly
faggits
faggly
faggot
faggoted
faggoter
faggotes
faggoting
faggotly
faggots
faggs
faging
fagly
fagot
fagoted
fagoter
fagotes
fagoting
fagotly
fagots
fags
fagsed
fagser
fagses
fagsing
fagsly
fagss
faig
faiged
faiger
faiges
faiging
faigly
faigs
faigt
faigted
faigter
faigtes
faigting
faigtly
faigts
fannybandit
fannybandited
fannybanditer
fannybandites
fannybanditing
fannybanditly
fannybandits
farted
farter
fartes
farting
fartknocker
fartknockered
fartknockerer
fartknockeres
fartknockering
fartknockerly
fartknockers
fartly
farts
felch
felched
felcher
felchered
felcherer
felcheres
felchering
felcherly
felchers
felches
felching
felchinged
felchinger
felchinges
felchinging
felchingly
felchings
felchly
felchs
fellate
fellateed
fellateer
fellatees
fellateing
fellately
fellates
fellatio
fellatioed
fellatioer
fellatioes
fellatioing
fellatioly
fellatios
feltch
feltched
feltcher
feltchered
feltcherer
feltcheres
feltchering
feltcherly
feltchers
feltches
feltching
feltchly
feltchs
feom
feomed
feomer
feomes
feoming
feomly
feoms
fisted
fisteded
fisteder
fistedes
fisteding
fistedly
fisteds
fisting
fistinged
fistinger
fistinges
fistinging
fistingly
fistings
fisty
fistyed
fistyer
fistyes
fistying
fistyly
fistys
floozy
floozyed
floozyer
floozyes
floozying
floozyly
floozys
foad
foaded
foader
foades
foading
foadly
foads
fondleed
fondleer
fondlees
fondleing
fondlely
fondles
foobar
foobared
foobarer
foobares
foobaring
foobarly
foobars
freex
freexed
freexer
freexes
freexing
freexly
freexs
frigg
frigga
friggaed
friggaer
friggaes
friggaing
friggaly
friggas
frigged
frigger
frigges
frigging
friggly
friggs
fubar
fubared
fubarer
fubares
fubaring
fubarly
fubars
fuck
fuckass
fuckassed
fuckasser
fuckasses
fuckassing
fuckassly
fuckasss
fucked
fuckeded
fuckeder
fuckedes
fuckeding
fuckedly
fuckeds
fucker
fuckered
fuckerer
fuckeres
fuckering
fuckerly
fuckers
fuckes
fuckface
fuckfaceed
fuckfaceer
fuckfacees
fuckfaceing
fuckfacely
fuckfaces
fuckin
fuckined
fuckiner
fuckines
fucking
fuckinged
fuckinger
fuckinges
fuckinging
fuckingly
fuckings
fuckining
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In scleroderma, GERD questionnaires are essential tools
Every rheumatologist ought to be comfortable in using a validated gastrointestinal symptom scale for evaluation of gastroesophageal reflux disease in patients with scleroderma, Tracy M. Frech, MD, declared at the virtual edition of the American College of Rheumatology’s 2020 State-of-the-Art Clinical Symposium.
About 90% of scleroderma patients will develop GI tract involvement during the course of their connective tissue disease. And while any portion of the GI tract from esophagus to anus can be involved, the most common GI manifestation is gastroesophageal reflux disease (GERD), affecting up to 90% of scleroderma patients, observed Dr. Frech, a rheumatologist and director of the systemic sclerosis clinic at the University of Utah and the George E. Wahlen Department of Veterans Affairs Medical Center, both in Salt Lake City.
“It is essential to ask scleroderma patients questions in order to understand their gastrointestinal tract symptoms. The questionnaires are really critical for us to grade the severity and then properly order tests,” she explained. “The goal is symptom identification, ideally with minimal time burden and at no cost, to guide decisions that move our patients’ care forward.”
Three of the most useful validated instruments for assessment of GERD symptoms in scleroderma patients in routine clinical practice are the GerdQ, the University of California, Los Angeles, Scleroderma Clinical Trial Consortium GI Tract Questionnaire (UCLA GIT) 2.0 reflux scale, and the Patient-Reported Outcomes Measurement Information System (PROMIS) reflux scale.
The GerdQ is a six-item, self-administered questionnaire in which patients specify how many days in the past week they have experienced heartburn, regurgitation, nausea, sleep interference, upper abdominal pain, and need for medication. A free online tool is available for calculating the likelihood of having GERD based upon GerdQ score. A score of 8 or more points out of a possible 18 has the highest sensitivity and specificity for diagnosis of GERD.
The UCLA GIT 2.0 – the most commonly used instrument for GI symptom assessment in scleroderma patients – includes 34 items. It takes 6-8 minutes to complete the whole thing, but patients being assessed for GERD only need answer the eight GERD-specific questions. Six of these eight questions are the same as in the GerdQ. One of the two extra questions asks about difficulty in swallowing solid food, which if answered affirmatively warrants early referral to a gastroenterologist. The other question inquires about any food triggers for the reflux, providing an opportunity for a rheumatologist to educate the patient about the importance of avoiding acidic foods, such as tomatoes, and other food and drink generally considered healthy but which actually exacerbate GERD.
The National Institutes of Health PROMIS scale, the newest of the three instruments, is a 60-item questionnaire; however, only 20 questions relate to reflux and dysphagia and are thus germane to a focused GERD assessment in scleroderma.
When a clinical diagnosis of GERD is made in a scleroderma patient based upon symptoms elicited by questionnaire, guidelines recommend a trial of empiric proton pump inhibitor therapy and behavioral interventions, such as raising the head of the bed, in order to confirm the diagnosis. If the patient reports feeling better after these basic interventions, the diagnosis is confirmed. If not, it’s time to make a referral to a gastroenterologist for specialized care, Dr. Frech said.
Dr. Frech was a coinvestigator in an international, prospective, longitudinal study of patient-reported outcomes measures in 116 patients with scleroderma and GERD. All study participants had to complete the UCLA GIT 2.0, the PROMIS reflux scale, and a third patient-reported GERD measure both before and after the therapeutic intervention. The UCLA GIT 2.0 and PROMIS instruments demonstrated similarly robust sensitivity for identifying changes in GERD symptoms after therapeutic intervention.
“It doesn’t really matter what questionnaire we’re using,” according to the rheumatologist. “But I will point out that there is significant overlap in symptoms among GERD, gastroparesis, functional dyspepsia, and eosinophilic esophagitis, all of which cause symptoms of heartburn and regurgitation. So we don’t want to ask these questions just once, we want to make an intervention and then reask the questions to ensure that we’re continuously moving forward with the gastrointestinal tract management plan.”
Dr. Frech reported having no financial conflicts regarding her presentation.
Every rheumatologist ought to be comfortable in using a validated gastrointestinal symptom scale for evaluation of gastroesophageal reflux disease in patients with scleroderma, Tracy M. Frech, MD, declared at the virtual edition of the American College of Rheumatology’s 2020 State-of-the-Art Clinical Symposium.
About 90% of scleroderma patients will develop GI tract involvement during the course of their connective tissue disease. And while any portion of the GI tract from esophagus to anus can be involved, the most common GI manifestation is gastroesophageal reflux disease (GERD), affecting up to 90% of scleroderma patients, observed Dr. Frech, a rheumatologist and director of the systemic sclerosis clinic at the University of Utah and the George E. Wahlen Department of Veterans Affairs Medical Center, both in Salt Lake City.
“It is essential to ask scleroderma patients questions in order to understand their gastrointestinal tract symptoms. The questionnaires are really critical for us to grade the severity and then properly order tests,” she explained. “The goal is symptom identification, ideally with minimal time burden and at no cost, to guide decisions that move our patients’ care forward.”
Three of the most useful validated instruments for assessment of GERD symptoms in scleroderma patients in routine clinical practice are the GerdQ, the University of California, Los Angeles, Scleroderma Clinical Trial Consortium GI Tract Questionnaire (UCLA GIT) 2.0 reflux scale, and the Patient-Reported Outcomes Measurement Information System (PROMIS) reflux scale.
The GerdQ is a six-item, self-administered questionnaire in which patients specify how many days in the past week they have experienced heartburn, regurgitation, nausea, sleep interference, upper abdominal pain, and need for medication. A free online tool is available for calculating the likelihood of having GERD based upon GerdQ score. A score of 8 or more points out of a possible 18 has the highest sensitivity and specificity for diagnosis of GERD.
The UCLA GIT 2.0 – the most commonly used instrument for GI symptom assessment in scleroderma patients – includes 34 items. It takes 6-8 minutes to complete the whole thing, but patients being assessed for GERD only need answer the eight GERD-specific questions. Six of these eight questions are the same as in the GerdQ. One of the two extra questions asks about difficulty in swallowing solid food, which if answered affirmatively warrants early referral to a gastroenterologist. The other question inquires about any food triggers for the reflux, providing an opportunity for a rheumatologist to educate the patient about the importance of avoiding acidic foods, such as tomatoes, and other food and drink generally considered healthy but which actually exacerbate GERD.
The National Institutes of Health PROMIS scale, the newest of the three instruments, is a 60-item questionnaire; however, only 20 questions relate to reflux and dysphagia and are thus germane to a focused GERD assessment in scleroderma.
When a clinical diagnosis of GERD is made in a scleroderma patient based upon symptoms elicited by questionnaire, guidelines recommend a trial of empiric proton pump inhibitor therapy and behavioral interventions, such as raising the head of the bed, in order to confirm the diagnosis. If the patient reports feeling better after these basic interventions, the diagnosis is confirmed. If not, it’s time to make a referral to a gastroenterologist for specialized care, Dr. Frech said.
Dr. Frech was a coinvestigator in an international, prospective, longitudinal study of patient-reported outcomes measures in 116 patients with scleroderma and GERD. All study participants had to complete the UCLA GIT 2.0, the PROMIS reflux scale, and a third patient-reported GERD measure both before and after the therapeutic intervention. The UCLA GIT 2.0 and PROMIS instruments demonstrated similarly robust sensitivity for identifying changes in GERD symptoms after therapeutic intervention.
“It doesn’t really matter what questionnaire we’re using,” according to the rheumatologist. “But I will point out that there is significant overlap in symptoms among GERD, gastroparesis, functional dyspepsia, and eosinophilic esophagitis, all of which cause symptoms of heartburn and regurgitation. So we don’t want to ask these questions just once, we want to make an intervention and then reask the questions to ensure that we’re continuously moving forward with the gastrointestinal tract management plan.”
Dr. Frech reported having no financial conflicts regarding her presentation.
Every rheumatologist ought to be comfortable in using a validated gastrointestinal symptom scale for evaluation of gastroesophageal reflux disease in patients with scleroderma, Tracy M. Frech, MD, declared at the virtual edition of the American College of Rheumatology’s 2020 State-of-the-Art Clinical Symposium.
About 90% of scleroderma patients will develop GI tract involvement during the course of their connective tissue disease. And while any portion of the GI tract from esophagus to anus can be involved, the most common GI manifestation is gastroesophageal reflux disease (GERD), affecting up to 90% of scleroderma patients, observed Dr. Frech, a rheumatologist and director of the systemic sclerosis clinic at the University of Utah and the George E. Wahlen Department of Veterans Affairs Medical Center, both in Salt Lake City.
“It is essential to ask scleroderma patients questions in order to understand their gastrointestinal tract symptoms. The questionnaires are really critical for us to grade the severity and then properly order tests,” she explained. “The goal is symptom identification, ideally with minimal time burden and at no cost, to guide decisions that move our patients’ care forward.”
Three of the most useful validated instruments for assessment of GERD symptoms in scleroderma patients in routine clinical practice are the GerdQ, the University of California, Los Angeles, Scleroderma Clinical Trial Consortium GI Tract Questionnaire (UCLA GIT) 2.0 reflux scale, and the Patient-Reported Outcomes Measurement Information System (PROMIS) reflux scale.
The GerdQ is a six-item, self-administered questionnaire in which patients specify how many days in the past week they have experienced heartburn, regurgitation, nausea, sleep interference, upper abdominal pain, and need for medication. A free online tool is available for calculating the likelihood of having GERD based upon GerdQ score. A score of 8 or more points out of a possible 18 has the highest sensitivity and specificity for diagnosis of GERD.
The UCLA GIT 2.0 – the most commonly used instrument for GI symptom assessment in scleroderma patients – includes 34 items. It takes 6-8 minutes to complete the whole thing, but patients being assessed for GERD only need answer the eight GERD-specific questions. Six of these eight questions are the same as in the GerdQ. One of the two extra questions asks about difficulty in swallowing solid food, which if answered affirmatively warrants early referral to a gastroenterologist. The other question inquires about any food triggers for the reflux, providing an opportunity for a rheumatologist to educate the patient about the importance of avoiding acidic foods, such as tomatoes, and other food and drink generally considered healthy but which actually exacerbate GERD.
The National Institutes of Health PROMIS scale, the newest of the three instruments, is a 60-item questionnaire; however, only 20 questions relate to reflux and dysphagia and are thus germane to a focused GERD assessment in scleroderma.
When a clinical diagnosis of GERD is made in a scleroderma patient based upon symptoms elicited by questionnaire, guidelines recommend a trial of empiric proton pump inhibitor therapy and behavioral interventions, such as raising the head of the bed, in order to confirm the diagnosis. If the patient reports feeling better after these basic interventions, the diagnosis is confirmed. If not, it’s time to make a referral to a gastroenterologist for specialized care, Dr. Frech said.
Dr. Frech was a coinvestigator in an international, prospective, longitudinal study of patient-reported outcomes measures in 116 patients with scleroderma and GERD. All study participants had to complete the UCLA GIT 2.0, the PROMIS reflux scale, and a third patient-reported GERD measure both before and after the therapeutic intervention. The UCLA GIT 2.0 and PROMIS instruments demonstrated similarly robust sensitivity for identifying changes in GERD symptoms after therapeutic intervention.
“It doesn’t really matter what questionnaire we’re using,” according to the rheumatologist. “But I will point out that there is significant overlap in symptoms among GERD, gastroparesis, functional dyspepsia, and eosinophilic esophagitis, all of which cause symptoms of heartburn and regurgitation. So we don’t want to ask these questions just once, we want to make an intervention and then reask the questions to ensure that we’re continuously moving forward with the gastrointestinal tract management plan.”
Dr. Frech reported having no financial conflicts regarding her presentation.
FROM SOTA 2020
First reported U.S. case of COVID-19 linked to Guillain-Barré syndrome
further supporting a link between the virus and neurologic complications, including GBS.
Physicians in China reported the first case of COVID-19 that initially presented as acute GBS. The patient was a 61-year-old woman returning home from Wuhan during the pandemic.
Subsequently, physicians in Italy reported five cases of GBS in association with COVID-19.
The first U.S. case is described in the June issue of the Journal of Clinical Neuromuscular Disease.
Like cases from China and Italy, the U.S. patient’s symptoms of GBS reportedly occurred within days of being infected with SARS-CoV-2. “This onset is similar to a case report of acute Zika virus infection with concurrent GBS suggesting a parainfectious complication,” first author Sandeep Rana, MD, and colleagues noted.
The 54-year-old man was transferred to Allegheny General Hospital after developing ascending limb weakness and numbness that followed symptoms of a respiratory infection. Two weeks earlier, he initially developed rhinorrhea, odynophagia, fevers, chills, and night sweats. The man reported that his wife had tested positive for COVID-19 and that his symptoms started soon after her illness. The man also tested positive for COVID-19.
His deficits were characterized by quadriparesis and areflexia, burning dysesthesias, mild ophthalmoparesis, and dysautonomia. He did not have the loss of smell and taste documented in other COVID-19 patients. He briefly required mechanical ventilation and was successfully weaned after receiving a course of intravenous immunoglobulin.
Compared with other cases reported in the literature, the unique clinical features in the U.S. case are urinary retention secondary to dysautonomia and ocular symptoms of diplopia. These highlight the variability in the clinical presentation of GBS associated with COVID-19, the researchers noted.
They added that, with the Pittsburgh patient, electrophysiological findings were typical of demyelinating polyneuropathy seen in patients with GBS. The case series from Italy suggests that axonal variants could be as common in COVID-19–associated GBS.
“Although the number of documented cases internationally is notably small to date, it’s not completely surprising that a COVID-19 diagnosis may lead to a patient developing GBS. The increase of inflammation and inflammatory cells caused by the infection may trigger an irregular immune response that leads to the hallmark symptoms of this neurological disorder,” Dr. Rana said in a news release.
“Since GBS can significantly affect the respiratory system and other vital organs being pushed into overdrive during a COVID-19 immune response, it will be critically important to further investigate and understand this potential connection,” he added.
A version of this article originally appeared on Medscape.com.
further supporting a link between the virus and neurologic complications, including GBS.
Physicians in China reported the first case of COVID-19 that initially presented as acute GBS. The patient was a 61-year-old woman returning home from Wuhan during the pandemic.
Subsequently, physicians in Italy reported five cases of GBS in association with COVID-19.
The first U.S. case is described in the June issue of the Journal of Clinical Neuromuscular Disease.
Like cases from China and Italy, the U.S. patient’s symptoms of GBS reportedly occurred within days of being infected with SARS-CoV-2. “This onset is similar to a case report of acute Zika virus infection with concurrent GBS suggesting a parainfectious complication,” first author Sandeep Rana, MD, and colleagues noted.
The 54-year-old man was transferred to Allegheny General Hospital after developing ascending limb weakness and numbness that followed symptoms of a respiratory infection. Two weeks earlier, he initially developed rhinorrhea, odynophagia, fevers, chills, and night sweats. The man reported that his wife had tested positive for COVID-19 and that his symptoms started soon after her illness. The man also tested positive for COVID-19.
His deficits were characterized by quadriparesis and areflexia, burning dysesthesias, mild ophthalmoparesis, and dysautonomia. He did not have the loss of smell and taste documented in other COVID-19 patients. He briefly required mechanical ventilation and was successfully weaned after receiving a course of intravenous immunoglobulin.
Compared with other cases reported in the literature, the unique clinical features in the U.S. case are urinary retention secondary to dysautonomia and ocular symptoms of diplopia. These highlight the variability in the clinical presentation of GBS associated with COVID-19, the researchers noted.
They added that, with the Pittsburgh patient, electrophysiological findings were typical of demyelinating polyneuropathy seen in patients with GBS. The case series from Italy suggests that axonal variants could be as common in COVID-19–associated GBS.
“Although the number of documented cases internationally is notably small to date, it’s not completely surprising that a COVID-19 diagnosis may lead to a patient developing GBS. The increase of inflammation and inflammatory cells caused by the infection may trigger an irregular immune response that leads to the hallmark symptoms of this neurological disorder,” Dr. Rana said in a news release.
“Since GBS can significantly affect the respiratory system and other vital organs being pushed into overdrive during a COVID-19 immune response, it will be critically important to further investigate and understand this potential connection,” he added.
A version of this article originally appeared on Medscape.com.
further supporting a link between the virus and neurologic complications, including GBS.
Physicians in China reported the first case of COVID-19 that initially presented as acute GBS. The patient was a 61-year-old woman returning home from Wuhan during the pandemic.
Subsequently, physicians in Italy reported five cases of GBS in association with COVID-19.
The first U.S. case is described in the June issue of the Journal of Clinical Neuromuscular Disease.
Like cases from China and Italy, the U.S. patient’s symptoms of GBS reportedly occurred within days of being infected with SARS-CoV-2. “This onset is similar to a case report of acute Zika virus infection with concurrent GBS suggesting a parainfectious complication,” first author Sandeep Rana, MD, and colleagues noted.
The 54-year-old man was transferred to Allegheny General Hospital after developing ascending limb weakness and numbness that followed symptoms of a respiratory infection. Two weeks earlier, he initially developed rhinorrhea, odynophagia, fevers, chills, and night sweats. The man reported that his wife had tested positive for COVID-19 and that his symptoms started soon after her illness. The man also tested positive for COVID-19.
His deficits were characterized by quadriparesis and areflexia, burning dysesthesias, mild ophthalmoparesis, and dysautonomia. He did not have the loss of smell and taste documented in other COVID-19 patients. He briefly required mechanical ventilation and was successfully weaned after receiving a course of intravenous immunoglobulin.
Compared with other cases reported in the literature, the unique clinical features in the U.S. case are urinary retention secondary to dysautonomia and ocular symptoms of diplopia. These highlight the variability in the clinical presentation of GBS associated with COVID-19, the researchers noted.
They added that, with the Pittsburgh patient, electrophysiological findings were typical of demyelinating polyneuropathy seen in patients with GBS. The case series from Italy suggests that axonal variants could be as common in COVID-19–associated GBS.
“Although the number of documented cases internationally is notably small to date, it’s not completely surprising that a COVID-19 diagnosis may lead to a patient developing GBS. The increase of inflammation and inflammatory cells caused by the infection may trigger an irregular immune response that leads to the hallmark symptoms of this neurological disorder,” Dr. Rana said in a news release.
“Since GBS can significantly affect the respiratory system and other vital organs being pushed into overdrive during a COVID-19 immune response, it will be critically important to further investigate and understand this potential connection,” he added.
A version of this article originally appeared on Medscape.com.
What COVID-19 has taught us about senior care
Across the globe, there are marked differences in how countries responded to the COVID-19 outbreak, with varying degrees of success in limiting the spread of the virus. Some countries learned important lessons from previous outbreaks, including SARS and MERS, and put policies in place that contributed to lower infection and death rates from COVID-19 in these countries. Others struggled to respond appropriately to the outbreak.
The United States and most of the world was not affected significantly by SARS and MERS. Hence there is a need for different perspectives and observations on lessons that can be learned from this outbreak to help develop effective strategies and policies for the future. It also makes sense to focus intently on the demographic most affected by COVID-19 – the elderly.
Medical care, for the most part, is governed by protocols that clearly detail processes to be followed for the prevention and treatment of disease. Caring for older patients requires going above and beyond the protocols. That is one of the lessons learned from the COVID-19 pandemic – a wake-up call for a more proactive approach for at-risk patients, in this case everyone over the age of 60 years.
In this context, it is important for medical outreach to continue with the senior population long after the pandemic has run its course. Many seniors, particularly those susceptible to other illnesses or exhibiting ongoing issues, would benefit from a consistent and preplanned pattern of contacts by medical professionals and agencies that work with the aging population. These proactive follow-ups can facilitate prevention and treatment and, at the same time, reduce costs that would otherwise increase when health care is reactive.
Lessons in infectious disease containment
As COVID-19 spread globally, there were contrasting responses from individual countries in their efforts to contain the disease. Unfortunately, Italy suffered from its decision to lock down only specific regions of the country initially. The leadership in Italy may have ignored the advice of medical experts and been caught off guard by the intensity of the spread of COVID-19. In fact, they might not have taken strict actions right away because they did not want their responses to be viewed as an overreaction to the disease.
The government decided to shut down areas where the infection rates were high (“red zones”) rather than implement restrictions nationally. This may have inadvertently increased the spread as Italians vacated those “red zones” for other areas of the country not yet affected by COVID-19. Italy’s decentralized health care system also played a part in the effects of the disease, with some regions demonstrating more success in slowing the reach of the disease. According to an article in the Harvard Business Review, the neighboring regions of Lombardy and Veneto applied similar approaches to social distancing and retail closures. Veneto was more proactive, and its response to the outbreak was multipronged, including putting a “strong emphasis on home diagnosis and care” and “specific efforts to monitor and protect health care and other essential workers.” These measures most likely contributed to a slowdown of the spread of the disease in Veneto’s health care facilities, which lessened the load on medical providers.1
Conversely, Taiwan implemented proactive measures swiftly after learning about COVID-19. Taiwan was impacted adversely by the SARS outbreak in 2003 and, afterward, revised their medical policies and procedures to respond quickly to future infectious disease crises. In the beginning, little was known about COVID-19 or how it spread. However, Taiwan’s swift public health response to COVID-19 included early travel restrictions, patient screening, and quarantining of symptomatic patients. The government emphasized education and created real-time digital updates and alerts sent to their citizens, as well as partnering with media to broadcast crucial proactive health information and quickly disproving false information related to COVID-19. They coordinated with organizations throughout the country to increase supplies of personal protective equipment (PPE).2
Although countries and even cities within a country differ in terms of population demographics, health resources, government policies, and cultural practices, initial success stories have some similarities, including the following:
- Early travel restrictions from countries with positive cases, with some circumstances requiring compulsory quarantine periods and testing before entry.
- Extensive testing and proactive tracing of symptomatic cases early. Contacts of people testing positive were also tested, irrespective of being symptomatic or asymptomatic. If testing kits were unavailable, the contacts were self-quarantined.
- Emphasis on avoiding overburdening hospitals by having the public health infrastructure to divert people exhibiting symptoms, including using public health hotlines to send patients to dedicated testing sites and drive-through testing, rather than have patients presenting to emergency rooms and hospitals. This approach protected medical staff from exposure and allowed the focus to remain on treating severe symptomatic patients.
The vastly different response to the COVID-19 outbreak in these two countries illuminates the need for better preparation in the United States. At the onset of this outbreak, emergency room medical professionals, hospitalists, and outpatient primary care providers did not know how to screen for or treat this virus. Additionally, there was limited information on the most effective contact protocols for medical professionals, patients, and visitors. Finally, the lack of PPE and COVID-19 test kits hindered the U.S. response. Once the country is on the road to recovery from COVID-19, it is imperative to set the groundwork to prepare for future outbreaks and create mechanisms to quickly identify vulnerable populations when outbreaks occur.
Senior care in future infectious disease outbreaks
How can medical providers translate lessons learned from this outbreak into improving the quality of care for seniors? The National Institute on Aging (NIA) maintains a website with information about healthy aging. Seniors and their caregivers can use this website to learn more about chronic diseases, lifestyle modifications, disease prevention, and mental health.
In times of a pandemic, this website provides consistent and accurate information and education. One recommendation for reaching the elderly population during future outbreaks is for NIA to develop and implement strategies to increase the use of the website, including adding more audio and visual interfaces and developing a mobile app. Other recommendations for improving the quality of care for seniors include the following:
1. Identify which populations may be most affected when future outbreaks occur.
2. Consider nontraditional platforms, including social media, for communicating with the general population and for medical providers worldwide to learn from each other about new diseases, including the signs, symptoms, and treatment plans. Some medical professionals created specific WhatsApp groups to communicate, and the World Health Organization sent updated information about COVID-19 to anyone who texted them via WhatsApp.3
3. Create a checklist of signs and symptoms related to current infectious diseases and assess every vulnerable patient.
4. Share these guidelines with medical facilities that treat these populations, such as senior care, assisted living and rehabilitation facilities, hospitals, and outpatient treatment centers. Teach the staff at these medical facilities how to screen patients for signs and symptoms of the disease.
5. Implement social isolation strategies, travel and visitor restrictions, and testing and screening as soon as possible at these medical facilities.
6. Recognize that these strategies may affect the psychological and emotional well-being of seniors, increasing their risk for depression and anxiety and negatively affecting their immunity and mental health. Additionally, the use of PPE, either by the medical providers or the patient, may cause anxiety in seniors and those with mild cognitive impairment.
7. Encourage these medical facilities to improve coping strategies with older patients, such as incorporating communication technology that helps seniors stay connected with their families, and participating in physical and mental exercise, as well as religious activities.
8. Ask these medical facilities to create isolation or quarantine rooms for infected seniors.
9. Work with family members to proactively report to medical professionals any symptoms noticed in their senior relatives. Educate seniors to report symptoms earlier.
10. Offer incentives for medical professionals to conduct on-site testing in primary care offices or senior care facilities instead of sending patients to hospital emergency rooms for evaluation. This will only be effective if there are enough test kits available.
11. Urge insurance companies and Medicare to allow additional medical visits for screening vulnerable populations. Encourage the use of telemedicine in place of in-office visits (preferably billed at the same rate as an in-office visit) where appropriate, especially with nonambulatory patients or those with transportation issues. Many insurance companies, including Medicare, approved COVID-19–related coverage of telemedicine in place of office visits to limit the spread of the disease.
12. Provide community health care and integration and better coordination of local, state, and national health care.
13. Hold regular epidemic and pandemic preparedness exercises in every hospital, nursing home, and assisted living facility.
Proactive health care outreach
It is easier to identify the signs and symptoms of already identified infectious diseases as opposed to a novel one like COVID-19. The United States faced a steep learning curve with COVID-19. Hospitalists and other medical professionals were not able to learn about COVID-19 in a journal. At first, they did not know how to screen patients coming into the ER, how to protect staff, or what the treatment plan was for this new disease. As a result, the medical system experienced disorder and confusion. Investing in community health care and better coordination of local, state, and national health care resources is a priority.
The senior citizen population appears to be most vulnerable to this virus and may be just as vulnerable in future outbreaks. Yet the insights gained from this pandemic can lead to a more comprehensive outreach to senior patients and increased screenings for comorbidities and future contagious diseases. An emphasis on proactive health care and outreach for seniors, with a focus on identifying and treating comorbid conditions, improves the medical care system overall and may prevent or slow future community outbreaks.
Dr. Kasarla is a hospitalist with APOGEE Physicians at Wise Surgical at Parkway in Fort Worth, Tex. He did his internal medicine residency at Mercy Hospital & Medical Center, Chicago. Readers can contact him at madhukarreddy.kasarla@apogeephysicians.com. Dr. Devireddy is a family physician at Positive Health Medical Center, Kingston, Jamaica. Contact him at drjaisheel@gmail.com.
References
1. Pisano GP et al. Lessons from Italy’s response to coronavirus. Harvard Business Review. 2020 Mar 27. https://hbr.org/2020/03/lessons-from-italys-response-to-coronavirus.
2. Tu C. Lessons from Taiwan’s experience with COVID-19. New Atlanticist. 2020 Apr 7. https://atlanticcouncil.org/blogs/new-atlanticist/lessons-from-taiwans-experience-with-covid-19/.
3. Newman LH. WhatsApp is at the center of coronavirus response. WIRED. 2020 Mar 20. https://www.wired.com/story/whatsapp-coronavirus-who-information-app/.
Across the globe, there are marked differences in how countries responded to the COVID-19 outbreak, with varying degrees of success in limiting the spread of the virus. Some countries learned important lessons from previous outbreaks, including SARS and MERS, and put policies in place that contributed to lower infection and death rates from COVID-19 in these countries. Others struggled to respond appropriately to the outbreak.
The United States and most of the world was not affected significantly by SARS and MERS. Hence there is a need for different perspectives and observations on lessons that can be learned from this outbreak to help develop effective strategies and policies for the future. It also makes sense to focus intently on the demographic most affected by COVID-19 – the elderly.
Medical care, for the most part, is governed by protocols that clearly detail processes to be followed for the prevention and treatment of disease. Caring for older patients requires going above and beyond the protocols. That is one of the lessons learned from the COVID-19 pandemic – a wake-up call for a more proactive approach for at-risk patients, in this case everyone over the age of 60 years.
In this context, it is important for medical outreach to continue with the senior population long after the pandemic has run its course. Many seniors, particularly those susceptible to other illnesses or exhibiting ongoing issues, would benefit from a consistent and preplanned pattern of contacts by medical professionals and agencies that work with the aging population. These proactive follow-ups can facilitate prevention and treatment and, at the same time, reduce costs that would otherwise increase when health care is reactive.
Lessons in infectious disease containment
As COVID-19 spread globally, there were contrasting responses from individual countries in their efforts to contain the disease. Unfortunately, Italy suffered from its decision to lock down only specific regions of the country initially. The leadership in Italy may have ignored the advice of medical experts and been caught off guard by the intensity of the spread of COVID-19. In fact, they might not have taken strict actions right away because they did not want their responses to be viewed as an overreaction to the disease.
The government decided to shut down areas where the infection rates were high (“red zones”) rather than implement restrictions nationally. This may have inadvertently increased the spread as Italians vacated those “red zones” for other areas of the country not yet affected by COVID-19. Italy’s decentralized health care system also played a part in the effects of the disease, with some regions demonstrating more success in slowing the reach of the disease. According to an article in the Harvard Business Review, the neighboring regions of Lombardy and Veneto applied similar approaches to social distancing and retail closures. Veneto was more proactive, and its response to the outbreak was multipronged, including putting a “strong emphasis on home diagnosis and care” and “specific efforts to monitor and protect health care and other essential workers.” These measures most likely contributed to a slowdown of the spread of the disease in Veneto’s health care facilities, which lessened the load on medical providers.1
Conversely, Taiwan implemented proactive measures swiftly after learning about COVID-19. Taiwan was impacted adversely by the SARS outbreak in 2003 and, afterward, revised their medical policies and procedures to respond quickly to future infectious disease crises. In the beginning, little was known about COVID-19 or how it spread. However, Taiwan’s swift public health response to COVID-19 included early travel restrictions, patient screening, and quarantining of symptomatic patients. The government emphasized education and created real-time digital updates and alerts sent to their citizens, as well as partnering with media to broadcast crucial proactive health information and quickly disproving false information related to COVID-19. They coordinated with organizations throughout the country to increase supplies of personal protective equipment (PPE).2
Although countries and even cities within a country differ in terms of population demographics, health resources, government policies, and cultural practices, initial success stories have some similarities, including the following:
- Early travel restrictions from countries with positive cases, with some circumstances requiring compulsory quarantine periods and testing before entry.
- Extensive testing and proactive tracing of symptomatic cases early. Contacts of people testing positive were also tested, irrespective of being symptomatic or asymptomatic. If testing kits were unavailable, the contacts were self-quarantined.
- Emphasis on avoiding overburdening hospitals by having the public health infrastructure to divert people exhibiting symptoms, including using public health hotlines to send patients to dedicated testing sites and drive-through testing, rather than have patients presenting to emergency rooms and hospitals. This approach protected medical staff from exposure and allowed the focus to remain on treating severe symptomatic patients.
The vastly different response to the COVID-19 outbreak in these two countries illuminates the need for better preparation in the United States. At the onset of this outbreak, emergency room medical professionals, hospitalists, and outpatient primary care providers did not know how to screen for or treat this virus. Additionally, there was limited information on the most effective contact protocols for medical professionals, patients, and visitors. Finally, the lack of PPE and COVID-19 test kits hindered the U.S. response. Once the country is on the road to recovery from COVID-19, it is imperative to set the groundwork to prepare for future outbreaks and create mechanisms to quickly identify vulnerable populations when outbreaks occur.
Senior care in future infectious disease outbreaks
How can medical providers translate lessons learned from this outbreak into improving the quality of care for seniors? The National Institute on Aging (NIA) maintains a website with information about healthy aging. Seniors and their caregivers can use this website to learn more about chronic diseases, lifestyle modifications, disease prevention, and mental health.
In times of a pandemic, this website provides consistent and accurate information and education. One recommendation for reaching the elderly population during future outbreaks is for NIA to develop and implement strategies to increase the use of the website, including adding more audio and visual interfaces and developing a mobile app. Other recommendations for improving the quality of care for seniors include the following:
1. Identify which populations may be most affected when future outbreaks occur.
2. Consider nontraditional platforms, including social media, for communicating with the general population and for medical providers worldwide to learn from each other about new diseases, including the signs, symptoms, and treatment plans. Some medical professionals created specific WhatsApp groups to communicate, and the World Health Organization sent updated information about COVID-19 to anyone who texted them via WhatsApp.3
3. Create a checklist of signs and symptoms related to current infectious diseases and assess every vulnerable patient.
4. Share these guidelines with medical facilities that treat these populations, such as senior care, assisted living and rehabilitation facilities, hospitals, and outpatient treatment centers. Teach the staff at these medical facilities how to screen patients for signs and symptoms of the disease.
5. Implement social isolation strategies, travel and visitor restrictions, and testing and screening as soon as possible at these medical facilities.
6. Recognize that these strategies may affect the psychological and emotional well-being of seniors, increasing their risk for depression and anxiety and negatively affecting their immunity and mental health. Additionally, the use of PPE, either by the medical providers or the patient, may cause anxiety in seniors and those with mild cognitive impairment.
7. Encourage these medical facilities to improve coping strategies with older patients, such as incorporating communication technology that helps seniors stay connected with their families, and participating in physical and mental exercise, as well as religious activities.
8. Ask these medical facilities to create isolation or quarantine rooms for infected seniors.
9. Work with family members to proactively report to medical professionals any symptoms noticed in their senior relatives. Educate seniors to report symptoms earlier.
10. Offer incentives for medical professionals to conduct on-site testing in primary care offices or senior care facilities instead of sending patients to hospital emergency rooms for evaluation. This will only be effective if there are enough test kits available.
11. Urge insurance companies and Medicare to allow additional medical visits for screening vulnerable populations. Encourage the use of telemedicine in place of in-office visits (preferably billed at the same rate as an in-office visit) where appropriate, especially with nonambulatory patients or those with transportation issues. Many insurance companies, including Medicare, approved COVID-19–related coverage of telemedicine in place of office visits to limit the spread of the disease.
12. Provide community health care and integration and better coordination of local, state, and national health care.
13. Hold regular epidemic and pandemic preparedness exercises in every hospital, nursing home, and assisted living facility.
Proactive health care outreach
It is easier to identify the signs and symptoms of already identified infectious diseases as opposed to a novel one like COVID-19. The United States faced a steep learning curve with COVID-19. Hospitalists and other medical professionals were not able to learn about COVID-19 in a journal. At first, they did not know how to screen patients coming into the ER, how to protect staff, or what the treatment plan was for this new disease. As a result, the medical system experienced disorder and confusion. Investing in community health care and better coordination of local, state, and national health care resources is a priority.
The senior citizen population appears to be most vulnerable to this virus and may be just as vulnerable in future outbreaks. Yet the insights gained from this pandemic can lead to a more comprehensive outreach to senior patients and increased screenings for comorbidities and future contagious diseases. An emphasis on proactive health care and outreach for seniors, with a focus on identifying and treating comorbid conditions, improves the medical care system overall and may prevent or slow future community outbreaks.
Dr. Kasarla is a hospitalist with APOGEE Physicians at Wise Surgical at Parkway in Fort Worth, Tex. He did his internal medicine residency at Mercy Hospital & Medical Center, Chicago. Readers can contact him at madhukarreddy.kasarla@apogeephysicians.com. Dr. Devireddy is a family physician at Positive Health Medical Center, Kingston, Jamaica. Contact him at drjaisheel@gmail.com.
References
1. Pisano GP et al. Lessons from Italy’s response to coronavirus. Harvard Business Review. 2020 Mar 27. https://hbr.org/2020/03/lessons-from-italys-response-to-coronavirus.
2. Tu C. Lessons from Taiwan’s experience with COVID-19. New Atlanticist. 2020 Apr 7. https://atlanticcouncil.org/blogs/new-atlanticist/lessons-from-taiwans-experience-with-covid-19/.
3. Newman LH. WhatsApp is at the center of coronavirus response. WIRED. 2020 Mar 20. https://www.wired.com/story/whatsapp-coronavirus-who-information-app/.
Across the globe, there are marked differences in how countries responded to the COVID-19 outbreak, with varying degrees of success in limiting the spread of the virus. Some countries learned important lessons from previous outbreaks, including SARS and MERS, and put policies in place that contributed to lower infection and death rates from COVID-19 in these countries. Others struggled to respond appropriately to the outbreak.
The United States and most of the world was not affected significantly by SARS and MERS. Hence there is a need for different perspectives and observations on lessons that can be learned from this outbreak to help develop effective strategies and policies for the future. It also makes sense to focus intently on the demographic most affected by COVID-19 – the elderly.
Medical care, for the most part, is governed by protocols that clearly detail processes to be followed for the prevention and treatment of disease. Caring for older patients requires going above and beyond the protocols. That is one of the lessons learned from the COVID-19 pandemic – a wake-up call for a more proactive approach for at-risk patients, in this case everyone over the age of 60 years.
In this context, it is important for medical outreach to continue with the senior population long after the pandemic has run its course. Many seniors, particularly those susceptible to other illnesses or exhibiting ongoing issues, would benefit from a consistent and preplanned pattern of contacts by medical professionals and agencies that work with the aging population. These proactive follow-ups can facilitate prevention and treatment and, at the same time, reduce costs that would otherwise increase when health care is reactive.
Lessons in infectious disease containment
As COVID-19 spread globally, there were contrasting responses from individual countries in their efforts to contain the disease. Unfortunately, Italy suffered from its decision to lock down only specific regions of the country initially. The leadership in Italy may have ignored the advice of medical experts and been caught off guard by the intensity of the spread of COVID-19. In fact, they might not have taken strict actions right away because they did not want their responses to be viewed as an overreaction to the disease.
The government decided to shut down areas where the infection rates were high (“red zones”) rather than implement restrictions nationally. This may have inadvertently increased the spread as Italians vacated those “red zones” for other areas of the country not yet affected by COVID-19. Italy’s decentralized health care system also played a part in the effects of the disease, with some regions demonstrating more success in slowing the reach of the disease. According to an article in the Harvard Business Review, the neighboring regions of Lombardy and Veneto applied similar approaches to social distancing and retail closures. Veneto was more proactive, and its response to the outbreak was multipronged, including putting a “strong emphasis on home diagnosis and care” and “specific efforts to monitor and protect health care and other essential workers.” These measures most likely contributed to a slowdown of the spread of the disease in Veneto’s health care facilities, which lessened the load on medical providers.1
Conversely, Taiwan implemented proactive measures swiftly after learning about COVID-19. Taiwan was impacted adversely by the SARS outbreak in 2003 and, afterward, revised their medical policies and procedures to respond quickly to future infectious disease crises. In the beginning, little was known about COVID-19 or how it spread. However, Taiwan’s swift public health response to COVID-19 included early travel restrictions, patient screening, and quarantining of symptomatic patients. The government emphasized education and created real-time digital updates and alerts sent to their citizens, as well as partnering with media to broadcast crucial proactive health information and quickly disproving false information related to COVID-19. They coordinated with organizations throughout the country to increase supplies of personal protective equipment (PPE).2
Although countries and even cities within a country differ in terms of population demographics, health resources, government policies, and cultural practices, initial success stories have some similarities, including the following:
- Early travel restrictions from countries with positive cases, with some circumstances requiring compulsory quarantine periods and testing before entry.
- Extensive testing and proactive tracing of symptomatic cases early. Contacts of people testing positive were also tested, irrespective of being symptomatic or asymptomatic. If testing kits were unavailable, the contacts were self-quarantined.
- Emphasis on avoiding overburdening hospitals by having the public health infrastructure to divert people exhibiting symptoms, including using public health hotlines to send patients to dedicated testing sites and drive-through testing, rather than have patients presenting to emergency rooms and hospitals. This approach protected medical staff from exposure and allowed the focus to remain on treating severe symptomatic patients.
The vastly different response to the COVID-19 outbreak in these two countries illuminates the need for better preparation in the United States. At the onset of this outbreak, emergency room medical professionals, hospitalists, and outpatient primary care providers did not know how to screen for or treat this virus. Additionally, there was limited information on the most effective contact protocols for medical professionals, patients, and visitors. Finally, the lack of PPE and COVID-19 test kits hindered the U.S. response. Once the country is on the road to recovery from COVID-19, it is imperative to set the groundwork to prepare for future outbreaks and create mechanisms to quickly identify vulnerable populations when outbreaks occur.
Senior care in future infectious disease outbreaks
How can medical providers translate lessons learned from this outbreak into improving the quality of care for seniors? The National Institute on Aging (NIA) maintains a website with information about healthy aging. Seniors and their caregivers can use this website to learn more about chronic diseases, lifestyle modifications, disease prevention, and mental health.
In times of a pandemic, this website provides consistent and accurate information and education. One recommendation for reaching the elderly population during future outbreaks is for NIA to develop and implement strategies to increase the use of the website, including adding more audio and visual interfaces and developing a mobile app. Other recommendations for improving the quality of care for seniors include the following:
1. Identify which populations may be most affected when future outbreaks occur.
2. Consider nontraditional platforms, including social media, for communicating with the general population and for medical providers worldwide to learn from each other about new diseases, including the signs, symptoms, and treatment plans. Some medical professionals created specific WhatsApp groups to communicate, and the World Health Organization sent updated information about COVID-19 to anyone who texted them via WhatsApp.3
3. Create a checklist of signs and symptoms related to current infectious diseases and assess every vulnerable patient.
4. Share these guidelines with medical facilities that treat these populations, such as senior care, assisted living and rehabilitation facilities, hospitals, and outpatient treatment centers. Teach the staff at these medical facilities how to screen patients for signs and symptoms of the disease.
5. Implement social isolation strategies, travel and visitor restrictions, and testing and screening as soon as possible at these medical facilities.
6. Recognize that these strategies may affect the psychological and emotional well-being of seniors, increasing their risk for depression and anxiety and negatively affecting their immunity and mental health. Additionally, the use of PPE, either by the medical providers or the patient, may cause anxiety in seniors and those with mild cognitive impairment.
7. Encourage these medical facilities to improve coping strategies with older patients, such as incorporating communication technology that helps seniors stay connected with their families, and participating in physical and mental exercise, as well as religious activities.
8. Ask these medical facilities to create isolation or quarantine rooms for infected seniors.
9. Work with family members to proactively report to medical professionals any symptoms noticed in their senior relatives. Educate seniors to report symptoms earlier.
10. Offer incentives for medical professionals to conduct on-site testing in primary care offices or senior care facilities instead of sending patients to hospital emergency rooms for evaluation. This will only be effective if there are enough test kits available.
11. Urge insurance companies and Medicare to allow additional medical visits for screening vulnerable populations. Encourage the use of telemedicine in place of in-office visits (preferably billed at the same rate as an in-office visit) where appropriate, especially with nonambulatory patients or those with transportation issues. Many insurance companies, including Medicare, approved COVID-19–related coverage of telemedicine in place of office visits to limit the spread of the disease.
12. Provide community health care and integration and better coordination of local, state, and national health care.
13. Hold regular epidemic and pandemic preparedness exercises in every hospital, nursing home, and assisted living facility.
Proactive health care outreach
It is easier to identify the signs and symptoms of already identified infectious diseases as opposed to a novel one like COVID-19. The United States faced a steep learning curve with COVID-19. Hospitalists and other medical professionals were not able to learn about COVID-19 in a journal. At first, they did not know how to screen patients coming into the ER, how to protect staff, or what the treatment plan was for this new disease. As a result, the medical system experienced disorder and confusion. Investing in community health care and better coordination of local, state, and national health care resources is a priority.
The senior citizen population appears to be most vulnerable to this virus and may be just as vulnerable in future outbreaks. Yet the insights gained from this pandemic can lead to a more comprehensive outreach to senior patients and increased screenings for comorbidities and future contagious diseases. An emphasis on proactive health care and outreach for seniors, with a focus on identifying and treating comorbid conditions, improves the medical care system overall and may prevent or slow future community outbreaks.
Dr. Kasarla is a hospitalist with APOGEE Physicians at Wise Surgical at Parkway in Fort Worth, Tex. He did his internal medicine residency at Mercy Hospital & Medical Center, Chicago. Readers can contact him at madhukarreddy.kasarla@apogeephysicians.com. Dr. Devireddy is a family physician at Positive Health Medical Center, Kingston, Jamaica. Contact him at drjaisheel@gmail.com.
References
1. Pisano GP et al. Lessons from Italy’s response to coronavirus. Harvard Business Review. 2020 Mar 27. https://hbr.org/2020/03/lessons-from-italys-response-to-coronavirus.
2. Tu C. Lessons from Taiwan’s experience with COVID-19. New Atlanticist. 2020 Apr 7. https://atlanticcouncil.org/blogs/new-atlanticist/lessons-from-taiwans-experience-with-covid-19/.
3. Newman LH. WhatsApp is at the center of coronavirus response. WIRED. 2020 Mar 20. https://www.wired.com/story/whatsapp-coronavirus-who-information-app/.
Telehealth and medical liability
The COVID-19 pandemic has led to the rapid uptake of telehealth nationwide in primary care and specialty practices. Over the last few months many practices have actually performed more telehealth visits than traditional in-person visits. The use of telehealth, which had been increasing slowly for the last few years, accelerated rapidly during the pandemic. Long term, telehealth has the potential to increase access to primary care and specialists, and make follow-up easier for many patients, changing how health care is delivered to millions of patients throughout the world.
Since telehealth will be a regular part of our practices from now on, it is important for clinicians to recognize how telehealth visits are viewed in a legal arena.
As is often the case with technological advances, the law needs time to adapt. Will a health care provider treating a patient using telemedicine be held to the same standard of care applicable to an in-person encounter? Stated differently, will consideration be given to the obvious limitations imposed by a telemedicine exam?
Standard of care in medical malpractice cases
The central question in most medical malpractice cases is whether the provider complied with the generally accepted standard of care when evaluating, diagnosing, or treating a patient. This standard typically takes into consideration the provider’s particular specialty as well as all the circumstances surrounding the encounter.1 Medical providers, not state legislators, usually define the standard of care for medical professionals. In malpractice cases, medical experts explain the applicable standard of care to the jury and guide its determination of whether, in the particular case, the standard of care was met. In this way, the law has long recognized that the medical profession itself is best suited to establish the appropriate standards of care under any particular set of circumstances. This standard of care is often referred to as the “reasonable professional under the circumstances” standard of care.
Telemedicine standard of care
Despite the fact that the complex and often nebulous concept of standard of care has been traditionally left to the medical experts to define, state legislators and regulators throughout the nation have chosen to weigh in on this issue in the context of telemedicine. Most states with telemedicine regulations have followed the model policy adopted by the Federation of State Medical Boards in April 2014 which states that “[t]reatment and consultation recommendations made in an online setting … will be held to the same standards of appropriate practice as those in traditional (in-person) settings.”2 States that have adopted this model policy have effectively created a “legal fiction” requiring a jury to ignore the fact that the care was provided virtually by telemedicine technologies and instead assume that the physician treated the patient in person, i.e, applying an “in-person” standard of care. Hawaii appears to be the lone notable exception. Its telemedicine law recognizes that an in-person standard of care should not be applied if there was not a face-to-face visit.3
Proponents of the in-person telemedicine standard claim that it is necessary to ensure patient safety, thus justifying the “legal fiction.” Holding the provider to the in-person standard, it is argued, forces the physician to err on the side of caution and require an actual in-person encounter to ensure the advantages of sight, touch, and sense of things are fully available.4 This discourages the use of telemedicine and deprives the population of its many benefits.
Telemedicine can overcome geographical barriers, increase clinical support, improve health outcomes, reduce health care costs, encourage patient input, reduce travel, and foster continuity of care. The pandemic, which has significantly limited the ability of providers to see patients in person, only underscores the benefits of telemedicine.
The legislatively imposed in-person telemedicine standard of care should be replaced with the “reasonable professional under the circumstances” standard in order to fairly judge physicians’ care and promote overall population health. The “reasonable professional under the circumstances” standard has applied to physicians and other health care professionals outside of telemedicine for decades, and it has served the medical community and public well. It is unfortunate that legislators felt the need to weigh in and define a distinctly different standard of care for telemedicine than for the rest of medicine, as this may present unforeseen obstacles to the use of telemedicine.
The in-person telemedicine standard of care remains a significant barrier for long-term telemedicine. Eliminating this legal fiction has the potential to further expand physicians’ use of telemedicine and fulfill its promise of improving access to care and improving population health.
Mr. Horner (partner), Mr. Milewski (partner), and Mr. Gajer (associate) are attorneys with White and Williams. They specialize in defending health care providers in medical malpractice lawsuits and other health care–related matters. Dr. Skolnik is professor of family and community Medicine at the Sidney Kimmel Medical College, Philadelphia, and associate director of the family medicine residency program at Abington (Pa.) Jefferson Health. Follow Dr. Skolnik, and feel free to submit questions to him on Twitter: @neilskolnik. The authors have no financial conflicts related to the content of this piece.
References
1. Cowan v. Doering, 111 N.J. 451-62,.1988.
2. Model Policy For The Appropriate Use Of Telemedicine Technologies In The Practice Of Medicine. State Medical Boards Appropriate Regulation of Telemedicine. April 2014..
3. Haw. Rev. Stat. Ann. § 453-1.3(c).
4. Kaspar BJ. Iowa Law Review. 2014 Jan;99:839-59.
The COVID-19 pandemic has led to the rapid uptake of telehealth nationwide in primary care and specialty practices. Over the last few months many practices have actually performed more telehealth visits than traditional in-person visits. The use of telehealth, which had been increasing slowly for the last few years, accelerated rapidly during the pandemic. Long term, telehealth has the potential to increase access to primary care and specialists, and make follow-up easier for many patients, changing how health care is delivered to millions of patients throughout the world.
Since telehealth will be a regular part of our practices from now on, it is important for clinicians to recognize how telehealth visits are viewed in a legal arena.
As is often the case with technological advances, the law needs time to adapt. Will a health care provider treating a patient using telemedicine be held to the same standard of care applicable to an in-person encounter? Stated differently, will consideration be given to the obvious limitations imposed by a telemedicine exam?
Standard of care in medical malpractice cases
The central question in most medical malpractice cases is whether the provider complied with the generally accepted standard of care when evaluating, diagnosing, or treating a patient. This standard typically takes into consideration the provider’s particular specialty as well as all the circumstances surrounding the encounter.1 Medical providers, not state legislators, usually define the standard of care for medical professionals. In malpractice cases, medical experts explain the applicable standard of care to the jury and guide its determination of whether, in the particular case, the standard of care was met. In this way, the law has long recognized that the medical profession itself is best suited to establish the appropriate standards of care under any particular set of circumstances. This standard of care is often referred to as the “reasonable professional under the circumstances” standard of care.
Telemedicine standard of care
Despite the fact that the complex and often nebulous concept of standard of care has been traditionally left to the medical experts to define, state legislators and regulators throughout the nation have chosen to weigh in on this issue in the context of telemedicine. Most states with telemedicine regulations have followed the model policy adopted by the Federation of State Medical Boards in April 2014 which states that “[t]reatment and consultation recommendations made in an online setting … will be held to the same standards of appropriate practice as those in traditional (in-person) settings.”2 States that have adopted this model policy have effectively created a “legal fiction” requiring a jury to ignore the fact that the care was provided virtually by telemedicine technologies and instead assume that the physician treated the patient in person, i.e, applying an “in-person” standard of care. Hawaii appears to be the lone notable exception. Its telemedicine law recognizes that an in-person standard of care should not be applied if there was not a face-to-face visit.3
Proponents of the in-person telemedicine standard claim that it is necessary to ensure patient safety, thus justifying the “legal fiction.” Holding the provider to the in-person standard, it is argued, forces the physician to err on the side of caution and require an actual in-person encounter to ensure the advantages of sight, touch, and sense of things are fully available.4 This discourages the use of telemedicine and deprives the population of its many benefits.
Telemedicine can overcome geographical barriers, increase clinical support, improve health outcomes, reduce health care costs, encourage patient input, reduce travel, and foster continuity of care. The pandemic, which has significantly limited the ability of providers to see patients in person, only underscores the benefits of telemedicine.
The legislatively imposed in-person telemedicine standard of care should be replaced with the “reasonable professional under the circumstances” standard in order to fairly judge physicians’ care and promote overall population health. The “reasonable professional under the circumstances” standard has applied to physicians and other health care professionals outside of telemedicine for decades, and it has served the medical community and public well. It is unfortunate that legislators felt the need to weigh in and define a distinctly different standard of care for telemedicine than for the rest of medicine, as this may present unforeseen obstacles to the use of telemedicine.
The in-person telemedicine standard of care remains a significant barrier for long-term telemedicine. Eliminating this legal fiction has the potential to further expand physicians’ use of telemedicine and fulfill its promise of improving access to care and improving population health.
Mr. Horner (partner), Mr. Milewski (partner), and Mr. Gajer (associate) are attorneys with White and Williams. They specialize in defending health care providers in medical malpractice lawsuits and other health care–related matters. Dr. Skolnik is professor of family and community Medicine at the Sidney Kimmel Medical College, Philadelphia, and associate director of the family medicine residency program at Abington (Pa.) Jefferson Health. Follow Dr. Skolnik, and feel free to submit questions to him on Twitter: @neilskolnik. The authors have no financial conflicts related to the content of this piece.
References
1. Cowan v. Doering, 111 N.J. 451-62,.1988.
2. Model Policy For The Appropriate Use Of Telemedicine Technologies In The Practice Of Medicine. State Medical Boards Appropriate Regulation of Telemedicine. April 2014..
3. Haw. Rev. Stat. Ann. § 453-1.3(c).
4. Kaspar BJ. Iowa Law Review. 2014 Jan;99:839-59.
The COVID-19 pandemic has led to the rapid uptake of telehealth nationwide in primary care and specialty practices. Over the last few months many practices have actually performed more telehealth visits than traditional in-person visits. The use of telehealth, which had been increasing slowly for the last few years, accelerated rapidly during the pandemic. Long term, telehealth has the potential to increase access to primary care and specialists, and make follow-up easier for many patients, changing how health care is delivered to millions of patients throughout the world.
Since telehealth will be a regular part of our practices from now on, it is important for clinicians to recognize how telehealth visits are viewed in a legal arena.
As is often the case with technological advances, the law needs time to adapt. Will a health care provider treating a patient using telemedicine be held to the same standard of care applicable to an in-person encounter? Stated differently, will consideration be given to the obvious limitations imposed by a telemedicine exam?
Standard of care in medical malpractice cases
The central question in most medical malpractice cases is whether the provider complied with the generally accepted standard of care when evaluating, diagnosing, or treating a patient. This standard typically takes into consideration the provider’s particular specialty as well as all the circumstances surrounding the encounter.1 Medical providers, not state legislators, usually define the standard of care for medical professionals. In malpractice cases, medical experts explain the applicable standard of care to the jury and guide its determination of whether, in the particular case, the standard of care was met. In this way, the law has long recognized that the medical profession itself is best suited to establish the appropriate standards of care under any particular set of circumstances. This standard of care is often referred to as the “reasonable professional under the circumstances” standard of care.
Telemedicine standard of care
Despite the fact that the complex and often nebulous concept of standard of care has been traditionally left to the medical experts to define, state legislators and regulators throughout the nation have chosen to weigh in on this issue in the context of telemedicine. Most states with telemedicine regulations have followed the model policy adopted by the Federation of State Medical Boards in April 2014 which states that “[t]reatment and consultation recommendations made in an online setting … will be held to the same standards of appropriate practice as those in traditional (in-person) settings.”2 States that have adopted this model policy have effectively created a “legal fiction” requiring a jury to ignore the fact that the care was provided virtually by telemedicine technologies and instead assume that the physician treated the patient in person, i.e, applying an “in-person” standard of care. Hawaii appears to be the lone notable exception. Its telemedicine law recognizes that an in-person standard of care should not be applied if there was not a face-to-face visit.3
Proponents of the in-person telemedicine standard claim that it is necessary to ensure patient safety, thus justifying the “legal fiction.” Holding the provider to the in-person standard, it is argued, forces the physician to err on the side of caution and require an actual in-person encounter to ensure the advantages of sight, touch, and sense of things are fully available.4 This discourages the use of telemedicine and deprives the population of its many benefits.
Telemedicine can overcome geographical barriers, increase clinical support, improve health outcomes, reduce health care costs, encourage patient input, reduce travel, and foster continuity of care. The pandemic, which has significantly limited the ability of providers to see patients in person, only underscores the benefits of telemedicine.
The legislatively imposed in-person telemedicine standard of care should be replaced with the “reasonable professional under the circumstances” standard in order to fairly judge physicians’ care and promote overall population health. The “reasonable professional under the circumstances” standard has applied to physicians and other health care professionals outside of telemedicine for decades, and it has served the medical community and public well. It is unfortunate that legislators felt the need to weigh in and define a distinctly different standard of care for telemedicine than for the rest of medicine, as this may present unforeseen obstacles to the use of telemedicine.
The in-person telemedicine standard of care remains a significant barrier for long-term telemedicine. Eliminating this legal fiction has the potential to further expand physicians’ use of telemedicine and fulfill its promise of improving access to care and improving population health.
Mr. Horner (partner), Mr. Milewski (partner), and Mr. Gajer (associate) are attorneys with White and Williams. They specialize in defending health care providers in medical malpractice lawsuits and other health care–related matters. Dr. Skolnik is professor of family and community Medicine at the Sidney Kimmel Medical College, Philadelphia, and associate director of the family medicine residency program at Abington (Pa.) Jefferson Health. Follow Dr. Skolnik, and feel free to submit questions to him on Twitter: @neilskolnik. The authors have no financial conflicts related to the content of this piece.
References
1. Cowan v. Doering, 111 N.J. 451-62,.1988.
2. Model Policy For The Appropriate Use Of Telemedicine Technologies In The Practice Of Medicine. State Medical Boards Appropriate Regulation of Telemedicine. April 2014..
3. Haw. Rev. Stat. Ann. § 453-1.3(c).
4. Kaspar BJ. Iowa Law Review. 2014 Jan;99:839-59.
COVID-19: Medicare data show long hospital stays, disparities
according to a new analysis by the Centers for Medicare & Medicaid Services.
CMS encounter and claims data show almost 110,000 hospital stays for COVID-19 from Jan. 1 to May 16, 2020. Of the longer admissions, 18% were 8-10 days, 16% were 11-15 days, and another 16% were 16 days or longer, the CMS reported in a preliminary data snapshot released June 22.
The hospitalization rate for the Medicare population was 175 per 100,000 as of May 16, but the CMS data show a number of disparities involving race/ethnicity and other demographic characteristics were uncovered, such as the following:
- Black patients were hospitalized for COVID-19 at a much higher rate, at 465 per 100,000 beneficiaries, than were Hispanics (258), Asians (187), and whites (123).
- Residents of urban/suburban areas had a much higher hospitalization rate than did those living in rural areas: 205 versus 57 per 100,000.
- Beneficiaries enrolled in both Medicare and Medicaid had 473 hospitalizations per 100,000, but the rate for those with Medicare only was 112.
“The disparities in the data reflect longstanding challenges facing minority communities and low-income older adults, many of whom face structural challenges to their health that go far beyond what is traditionally considered ‘medical,’ ” CMS Administrator Seema Verma said in a separate statement.
according to a new analysis by the Centers for Medicare & Medicaid Services.
CMS encounter and claims data show almost 110,000 hospital stays for COVID-19 from Jan. 1 to May 16, 2020. Of the longer admissions, 18% were 8-10 days, 16% were 11-15 days, and another 16% were 16 days or longer, the CMS reported in a preliminary data snapshot released June 22.
The hospitalization rate for the Medicare population was 175 per 100,000 as of May 16, but the CMS data show a number of disparities involving race/ethnicity and other demographic characteristics were uncovered, such as the following:
- Black patients were hospitalized for COVID-19 at a much higher rate, at 465 per 100,000 beneficiaries, than were Hispanics (258), Asians (187), and whites (123).
- Residents of urban/suburban areas had a much higher hospitalization rate than did those living in rural areas: 205 versus 57 per 100,000.
- Beneficiaries enrolled in both Medicare and Medicaid had 473 hospitalizations per 100,000, but the rate for those with Medicare only was 112.
“The disparities in the data reflect longstanding challenges facing minority communities and low-income older adults, many of whom face structural challenges to their health that go far beyond what is traditionally considered ‘medical,’ ” CMS Administrator Seema Verma said in a separate statement.
according to a new analysis by the Centers for Medicare & Medicaid Services.
CMS encounter and claims data show almost 110,000 hospital stays for COVID-19 from Jan. 1 to May 16, 2020. Of the longer admissions, 18% were 8-10 days, 16% were 11-15 days, and another 16% were 16 days or longer, the CMS reported in a preliminary data snapshot released June 22.
The hospitalization rate for the Medicare population was 175 per 100,000 as of May 16, but the CMS data show a number of disparities involving race/ethnicity and other demographic characteristics were uncovered, such as the following:
- Black patients were hospitalized for COVID-19 at a much higher rate, at 465 per 100,000 beneficiaries, than were Hispanics (258), Asians (187), and whites (123).
- Residents of urban/suburban areas had a much higher hospitalization rate than did those living in rural areas: 205 versus 57 per 100,000.
- Beneficiaries enrolled in both Medicare and Medicaid had 473 hospitalizations per 100,000, but the rate for those with Medicare only was 112.
“The disparities in the data reflect longstanding challenges facing minority communities and low-income older adults, many of whom face structural challenges to their health that go far beyond what is traditionally considered ‘medical,’ ” CMS Administrator Seema Verma said in a separate statement.
Inside Mercy’s mission to care for non-COVID patients in Los Angeles
When the hospital ship USNS Mercy departed San Diego’s Naval Station North Island on March 23, 2020, to support the Department of Defense efforts in Los Angeles during the coronavirus outbreak, Commander Erin Blevins remembers the crew’s excitement was palpable.
“We normally do partnerships abroad and respond to tsunamis and earthquakes,” said Cdr. Blevins, MD, a pediatric hematologist-oncologist who served as director of medical services for the mission. “This was a slight change in situation, but still disaster relief in the form of a pandemic. We switched our mindset to putting together the best experts for an infectious disease pandemic versus an earthquake disaster relief.”
A new mission
The 1,000-bed Mercy ship – a converted San Clemente–class oil tanker that was delivered in 1986 – spent nearly 50 days pier side in Los Angeles as a referral hospital for non–COVID-19 patients, so that clinicians at Los Angeles area hospitals could care for an anticipated surge of COVID-19 patients. “We went into it with expectations of, ‘We’ll treat as many patients as you need us to take,” Cdr. Blevins recalled. “I don’t even think Los Angeles [health officials] knew exactly where they were going to peak and what the need was going to be.”
Between March 29 and May 15, about 1,071 medical personnel aboard the Mercy cared for 77 patients with an average age of 53 years who were referred from 11 Los Angeles area hospitals. The physicians, nurses, and other medical support personnel were drawn from military treatment facilities across the country. “We had additional people join us as we scoped the mission to be more medically heavy and surgically light,” said Captain John Rotruck, MD, an anesthesiologist who is commanding officer of Mercy’s medical treatment facility. “We did adjust to make sure that we had the right staffing mix to meet the parameters that we were assigned. That was the crux of the change: a change in flavors of staffing to ensure that we focused on ICU and ward medical care as opposed to very heavy surgical care in support of a combat operation.”
About 10% of the team consisted of reservists who volunteered for the mission. “There’s no way you could have walked around the ship and known who was active duty and who was reservist,” said Capt. Rotruck, who was formerly chief of staff at Walter Reed National Military Medical Center, Bethesda, Md. “They worked together so well, and I think that marriage of active duty who are used to working in a military medical treatment facility – in our case, a Navy medical treatment facility – together with our reservist physician colleagues who work in civilian facilities around the country, was beneficial. It was a synergistic relationship. I think both sides walked away learning quite a bit from each other.”
Start with screening
All crew members underwent a temperature check and completed a health screening questionnaire: once before departing their home of record and again before boarding Mercy. Based on those results, crew members and medical staff were screened for COVID-19 and tested as needed in order to minimize the risk of an outbreak aboard the ship.
Fewer than 1% of crew members developed COVID-19 or tested positive for the virus during the mission, according to Capt. Rotruck. Affected individuals were isolated and quarantined. “All staff have recovered and are doing well,” he said.
Mercy personnel worked with local health officials to ensure that all patients transferred to the ship tested negative for COVID-19. Physicians aboard the Mercy then worked directly with the patients’ civilian physician to ensure a safe and thorough turnover process before the patients were transferred.
From basic medical to trauma care
Care aboard the ship, which consists of open-bay medical wards, ranged from basic medical and surgical care to critical care and trauma. The most common procedures were cholecystectomies and orthopedic procedures, and the average length of stay was 4-5 days, according to Cdr. Blevins. Over the course of the mission, the medical professionals conducted 36 surgeries, 77 x-ray exams, 26 CT scans, and administered hundreds of ancillary studies ranging from routine labs to high-end x-rays and blood transfusion support.
“Within our ICU, we did have some end-of-life patients who ended up dying on our ship in comfort care,” Cdr. Blevins said. “Fortunately, we had a wonderful ICU team who had a great deal of experience with end-of-life care and were able to take care of these patients very comfortably and ensure good communication with family and loved ones during that time. In most instances we tried to make sure that people got to FaceTime or video chat with their loved one before they passed away.”
The Mercy, which includes 12 operating rooms, four x-ray units, and one CAT-scan unit, was not equipped to deliver pediatric or obstetrical care. Other unavailable services included psychiatry, oncology, cardiac and thoracic surgery, nuclear medicine, MRI, mammography, electrophysiology, cardiac catheterization, negative-pressure isolation, speech therapy, and occupational therapy.
Not your typical hospital experience
But for patients who did receive medical care aboard the Mercy – which made three 150-day deployments in recent years for the military-led humanitarian response known as Pacific Partnership in 2015, 2016, and 2018 – it was an experience that they are unlikely to forget.
“Every time a patient left the ship, our team on the ground surveyed them to see how their experience was and see what we could do to improve,” Cdr. Blevins said. “Across the board, they were all very appreciative of the medical care. We had a couple of veterans on board. They got [USNS Mercy] hats on their way out and seemed to very much enjoy a slightly different experience than they would get at a regular hospital.”
Capt. Rotruck added that the enthusiasm crew members had for supporting fellow Americans “really energized our team and really saturated that caring aspect of the people who interacted directly with patients,” he said. “It wasn’t just the physicians and nurses, but it was the staff delivering the food and coming to take blood samples and every other interaction that the patients had with our team. I think they really felt that enthusiasm for being there and supporting our neighbors in LA [Los Angeles].”
Crew life aboard the Mercy
Just as with any hospital on shore, personnel aboard the Mercy practiced preventive hygiene measures recommended by the Centers for Disease Control and Prevention to help prevent the spread of COVID-19, such as wearing cloth face masks, spacing out tables in the dining hall, closing indoor gyms, and devising creative ways to stay physically fit. Popular options included jogging around the perimeter of the ship and practicing yoga and calisthenics on the deck, “making sure you were physically distanced appropriately, and when you were done, putting your mask back on,” Cdr. Blevins said. Others supplemented their workouts with a pull-up bar on the deck. “In addition, we have a series of ramps that run on the starboard side of the ship that we can use for patient movement with litters on wheels or patient beds,” Capt. Rotruck said. “The uphill portion of those ramps represents a good workout opportunity as well.”
Downtime in an era of physical distancing also afforded crew members the opportunity to call or FaceTime with loved ones, watch streamed TV shows and movies, and work on their own professional development. Some continued with coursework for online degree programs offered by colleges and universities they were enrolled in, while some enlisted personnel used the time to complete the Navy Enlisted Warfare Qualification Programs Instruction, which issues the basic overarching requirements for the qualification and designation of all enlisted warfare programs.
“As you can imagine, people spend a lot of time learning how the ship works and how it integrates into larger naval forces and so forth,” Capt. Rotruck said. “Not just our ship but also other ships: their weapons systems and defense mechanisms and navigation systems. We had people spending a significant amount of time working on that. We had people complete their Enlisted Surface Warfare qualification while we were on the mission.”
End of the mission
Mercy returned to its home base in San Diego on May 15, but about 60 medical personnel stayed behind in Los Angeles to support Federal Emergency Management Agency (FEMA), state, and local health care professionals. Some worked at a site where clinicians provided care for COVID-19–positive patients who had been transferred from area skilled nursing facilities.
In addition, a team consisting of one nurse and five corpsmen “would go out to individual skilled nursing facilities and mainly conduct assessments and training, such as training in donning proper PPE [personal protective equipment] and determining what needs they had,” Capt. Rotruck said. “They met those needs if possible or [communicated with California officials] and let them know what the requirements were and what the needs were in that facility.” The assignment for those who stayed behind ended on May 31.
On the opposite coast, Mercy’s sister ship, USNS Comfort, arrived in New York Harbor from Norfolk, Va., on March 30 and spent 3½ weeks assisting area hospitals in the COVID-19 pandemic fight. A few days into the mission, Comfort’s internal spaces were reconfigured to create separate COVID-negative and COVID-positive sections. Medical teams aboard the ship cared for a total of 182 patients during the assignment.
Looking back on Mercy’s mission, Cdr. Blevins marveled at the sense of teamwork that unfolded. “We have quarterly training exercises with a core set of personnel, [and] we train getting ready for activation in 5 days,” she said. “All of that training kicks in and it comes to fruition in a mission like this. It was terrific to see a group of very disparate subject matter experts from all over the country come together with one purpose: which was to serve our own country during the pandemic.”
Capt. Rotruck pointed out that the experience enabled enlisted and nonenlisted physicians to maintain their skill sets during a time when military and civilian hospitals had stopped doing elective procedures and routine appointments. “The fact that those people were able to come on board the ship and continue to conduct their medical practice and maintain their skills and competencies in an environment that they weren’t quite used to is great,” he said. “Otherwise, some of those medical personnel would have been sitting idle, wherever they were from. This is the power of Navy medicine on behalf of our country.”
When the hospital ship USNS Mercy departed San Diego’s Naval Station North Island on March 23, 2020, to support the Department of Defense efforts in Los Angeles during the coronavirus outbreak, Commander Erin Blevins remembers the crew’s excitement was palpable.
“We normally do partnerships abroad and respond to tsunamis and earthquakes,” said Cdr. Blevins, MD, a pediatric hematologist-oncologist who served as director of medical services for the mission. “This was a slight change in situation, but still disaster relief in the form of a pandemic. We switched our mindset to putting together the best experts for an infectious disease pandemic versus an earthquake disaster relief.”
A new mission
The 1,000-bed Mercy ship – a converted San Clemente–class oil tanker that was delivered in 1986 – spent nearly 50 days pier side in Los Angeles as a referral hospital for non–COVID-19 patients, so that clinicians at Los Angeles area hospitals could care for an anticipated surge of COVID-19 patients. “We went into it with expectations of, ‘We’ll treat as many patients as you need us to take,” Cdr. Blevins recalled. “I don’t even think Los Angeles [health officials] knew exactly where they were going to peak and what the need was going to be.”
Between March 29 and May 15, about 1,071 medical personnel aboard the Mercy cared for 77 patients with an average age of 53 years who were referred from 11 Los Angeles area hospitals. The physicians, nurses, and other medical support personnel were drawn from military treatment facilities across the country. “We had additional people join us as we scoped the mission to be more medically heavy and surgically light,” said Captain John Rotruck, MD, an anesthesiologist who is commanding officer of Mercy’s medical treatment facility. “We did adjust to make sure that we had the right staffing mix to meet the parameters that we were assigned. That was the crux of the change: a change in flavors of staffing to ensure that we focused on ICU and ward medical care as opposed to very heavy surgical care in support of a combat operation.”
About 10% of the team consisted of reservists who volunteered for the mission. “There’s no way you could have walked around the ship and known who was active duty and who was reservist,” said Capt. Rotruck, who was formerly chief of staff at Walter Reed National Military Medical Center, Bethesda, Md. “They worked together so well, and I think that marriage of active duty who are used to working in a military medical treatment facility – in our case, a Navy medical treatment facility – together with our reservist physician colleagues who work in civilian facilities around the country, was beneficial. It was a synergistic relationship. I think both sides walked away learning quite a bit from each other.”
Start with screening
All crew members underwent a temperature check and completed a health screening questionnaire: once before departing their home of record and again before boarding Mercy. Based on those results, crew members and medical staff were screened for COVID-19 and tested as needed in order to minimize the risk of an outbreak aboard the ship.
Fewer than 1% of crew members developed COVID-19 or tested positive for the virus during the mission, according to Capt. Rotruck. Affected individuals were isolated and quarantined. “All staff have recovered and are doing well,” he said.
Mercy personnel worked with local health officials to ensure that all patients transferred to the ship tested negative for COVID-19. Physicians aboard the Mercy then worked directly with the patients’ civilian physician to ensure a safe and thorough turnover process before the patients were transferred.
From basic medical to trauma care
Care aboard the ship, which consists of open-bay medical wards, ranged from basic medical and surgical care to critical care and trauma. The most common procedures were cholecystectomies and orthopedic procedures, and the average length of stay was 4-5 days, according to Cdr. Blevins. Over the course of the mission, the medical professionals conducted 36 surgeries, 77 x-ray exams, 26 CT scans, and administered hundreds of ancillary studies ranging from routine labs to high-end x-rays and blood transfusion support.
“Within our ICU, we did have some end-of-life patients who ended up dying on our ship in comfort care,” Cdr. Blevins said. “Fortunately, we had a wonderful ICU team who had a great deal of experience with end-of-life care and were able to take care of these patients very comfortably and ensure good communication with family and loved ones during that time. In most instances we tried to make sure that people got to FaceTime or video chat with their loved one before they passed away.”
The Mercy, which includes 12 operating rooms, four x-ray units, and one CAT-scan unit, was not equipped to deliver pediatric or obstetrical care. Other unavailable services included psychiatry, oncology, cardiac and thoracic surgery, nuclear medicine, MRI, mammography, electrophysiology, cardiac catheterization, negative-pressure isolation, speech therapy, and occupational therapy.
Not your typical hospital experience
But for patients who did receive medical care aboard the Mercy – which made three 150-day deployments in recent years for the military-led humanitarian response known as Pacific Partnership in 2015, 2016, and 2018 – it was an experience that they are unlikely to forget.
“Every time a patient left the ship, our team on the ground surveyed them to see how their experience was and see what we could do to improve,” Cdr. Blevins said. “Across the board, they were all very appreciative of the medical care. We had a couple of veterans on board. They got [USNS Mercy] hats on their way out and seemed to very much enjoy a slightly different experience than they would get at a regular hospital.”
Capt. Rotruck added that the enthusiasm crew members had for supporting fellow Americans “really energized our team and really saturated that caring aspect of the people who interacted directly with patients,” he said. “It wasn’t just the physicians and nurses, but it was the staff delivering the food and coming to take blood samples and every other interaction that the patients had with our team. I think they really felt that enthusiasm for being there and supporting our neighbors in LA [Los Angeles].”
Crew life aboard the Mercy
Just as with any hospital on shore, personnel aboard the Mercy practiced preventive hygiene measures recommended by the Centers for Disease Control and Prevention to help prevent the spread of COVID-19, such as wearing cloth face masks, spacing out tables in the dining hall, closing indoor gyms, and devising creative ways to stay physically fit. Popular options included jogging around the perimeter of the ship and practicing yoga and calisthenics on the deck, “making sure you were physically distanced appropriately, and when you were done, putting your mask back on,” Cdr. Blevins said. Others supplemented their workouts with a pull-up bar on the deck. “In addition, we have a series of ramps that run on the starboard side of the ship that we can use for patient movement with litters on wheels or patient beds,” Capt. Rotruck said. “The uphill portion of those ramps represents a good workout opportunity as well.”
Downtime in an era of physical distancing also afforded crew members the opportunity to call or FaceTime with loved ones, watch streamed TV shows and movies, and work on their own professional development. Some continued with coursework for online degree programs offered by colleges and universities they were enrolled in, while some enlisted personnel used the time to complete the Navy Enlisted Warfare Qualification Programs Instruction, which issues the basic overarching requirements for the qualification and designation of all enlisted warfare programs.
“As you can imagine, people spend a lot of time learning how the ship works and how it integrates into larger naval forces and so forth,” Capt. Rotruck said. “Not just our ship but also other ships: their weapons systems and defense mechanisms and navigation systems. We had people spending a significant amount of time working on that. We had people complete their Enlisted Surface Warfare qualification while we were on the mission.”
End of the mission
Mercy returned to its home base in San Diego on May 15, but about 60 medical personnel stayed behind in Los Angeles to support Federal Emergency Management Agency (FEMA), state, and local health care professionals. Some worked at a site where clinicians provided care for COVID-19–positive patients who had been transferred from area skilled nursing facilities.
In addition, a team consisting of one nurse and five corpsmen “would go out to individual skilled nursing facilities and mainly conduct assessments and training, such as training in donning proper PPE [personal protective equipment] and determining what needs they had,” Capt. Rotruck said. “They met those needs if possible or [communicated with California officials] and let them know what the requirements were and what the needs were in that facility.” The assignment for those who stayed behind ended on May 31.
On the opposite coast, Mercy’s sister ship, USNS Comfort, arrived in New York Harbor from Norfolk, Va., on March 30 and spent 3½ weeks assisting area hospitals in the COVID-19 pandemic fight. A few days into the mission, Comfort’s internal spaces were reconfigured to create separate COVID-negative and COVID-positive sections. Medical teams aboard the ship cared for a total of 182 patients during the assignment.
Looking back on Mercy’s mission, Cdr. Blevins marveled at the sense of teamwork that unfolded. “We have quarterly training exercises with a core set of personnel, [and] we train getting ready for activation in 5 days,” she said. “All of that training kicks in and it comes to fruition in a mission like this. It was terrific to see a group of very disparate subject matter experts from all over the country come together with one purpose: which was to serve our own country during the pandemic.”
Capt. Rotruck pointed out that the experience enabled enlisted and nonenlisted physicians to maintain their skill sets during a time when military and civilian hospitals had stopped doing elective procedures and routine appointments. “The fact that those people were able to come on board the ship and continue to conduct their medical practice and maintain their skills and competencies in an environment that they weren’t quite used to is great,” he said. “Otherwise, some of those medical personnel would have been sitting idle, wherever they were from. This is the power of Navy medicine on behalf of our country.”
When the hospital ship USNS Mercy departed San Diego’s Naval Station North Island on March 23, 2020, to support the Department of Defense efforts in Los Angeles during the coronavirus outbreak, Commander Erin Blevins remembers the crew’s excitement was palpable.
“We normally do partnerships abroad and respond to tsunamis and earthquakes,” said Cdr. Blevins, MD, a pediatric hematologist-oncologist who served as director of medical services for the mission. “This was a slight change in situation, but still disaster relief in the form of a pandemic. We switched our mindset to putting together the best experts for an infectious disease pandemic versus an earthquake disaster relief.”
A new mission
The 1,000-bed Mercy ship – a converted San Clemente–class oil tanker that was delivered in 1986 – spent nearly 50 days pier side in Los Angeles as a referral hospital for non–COVID-19 patients, so that clinicians at Los Angeles area hospitals could care for an anticipated surge of COVID-19 patients. “We went into it with expectations of, ‘We’ll treat as many patients as you need us to take,” Cdr. Blevins recalled. “I don’t even think Los Angeles [health officials] knew exactly where they were going to peak and what the need was going to be.”
Between March 29 and May 15, about 1,071 medical personnel aboard the Mercy cared for 77 patients with an average age of 53 years who were referred from 11 Los Angeles area hospitals. The physicians, nurses, and other medical support personnel were drawn from military treatment facilities across the country. “We had additional people join us as we scoped the mission to be more medically heavy and surgically light,” said Captain John Rotruck, MD, an anesthesiologist who is commanding officer of Mercy’s medical treatment facility. “We did adjust to make sure that we had the right staffing mix to meet the parameters that we were assigned. That was the crux of the change: a change in flavors of staffing to ensure that we focused on ICU and ward medical care as opposed to very heavy surgical care in support of a combat operation.”
About 10% of the team consisted of reservists who volunteered for the mission. “There’s no way you could have walked around the ship and known who was active duty and who was reservist,” said Capt. Rotruck, who was formerly chief of staff at Walter Reed National Military Medical Center, Bethesda, Md. “They worked together so well, and I think that marriage of active duty who are used to working in a military medical treatment facility – in our case, a Navy medical treatment facility – together with our reservist physician colleagues who work in civilian facilities around the country, was beneficial. It was a synergistic relationship. I think both sides walked away learning quite a bit from each other.”
Start with screening
All crew members underwent a temperature check and completed a health screening questionnaire: once before departing their home of record and again before boarding Mercy. Based on those results, crew members and medical staff were screened for COVID-19 and tested as needed in order to minimize the risk of an outbreak aboard the ship.
Fewer than 1% of crew members developed COVID-19 or tested positive for the virus during the mission, according to Capt. Rotruck. Affected individuals were isolated and quarantined. “All staff have recovered and are doing well,” he said.
Mercy personnel worked with local health officials to ensure that all patients transferred to the ship tested negative for COVID-19. Physicians aboard the Mercy then worked directly with the patients’ civilian physician to ensure a safe and thorough turnover process before the patients were transferred.
From basic medical to trauma care
Care aboard the ship, which consists of open-bay medical wards, ranged from basic medical and surgical care to critical care and trauma. The most common procedures were cholecystectomies and orthopedic procedures, and the average length of stay was 4-5 days, according to Cdr. Blevins. Over the course of the mission, the medical professionals conducted 36 surgeries, 77 x-ray exams, 26 CT scans, and administered hundreds of ancillary studies ranging from routine labs to high-end x-rays and blood transfusion support.
“Within our ICU, we did have some end-of-life patients who ended up dying on our ship in comfort care,” Cdr. Blevins said. “Fortunately, we had a wonderful ICU team who had a great deal of experience with end-of-life care and were able to take care of these patients very comfortably and ensure good communication with family and loved ones during that time. In most instances we tried to make sure that people got to FaceTime or video chat with their loved one before they passed away.”
The Mercy, which includes 12 operating rooms, four x-ray units, and one CAT-scan unit, was not equipped to deliver pediatric or obstetrical care. Other unavailable services included psychiatry, oncology, cardiac and thoracic surgery, nuclear medicine, MRI, mammography, electrophysiology, cardiac catheterization, negative-pressure isolation, speech therapy, and occupational therapy.
Not your typical hospital experience
But for patients who did receive medical care aboard the Mercy – which made three 150-day deployments in recent years for the military-led humanitarian response known as Pacific Partnership in 2015, 2016, and 2018 – it was an experience that they are unlikely to forget.
“Every time a patient left the ship, our team on the ground surveyed them to see how their experience was and see what we could do to improve,” Cdr. Blevins said. “Across the board, they were all very appreciative of the medical care. We had a couple of veterans on board. They got [USNS Mercy] hats on their way out and seemed to very much enjoy a slightly different experience than they would get at a regular hospital.”
Capt. Rotruck added that the enthusiasm crew members had for supporting fellow Americans “really energized our team and really saturated that caring aspect of the people who interacted directly with patients,” he said. “It wasn’t just the physicians and nurses, but it was the staff delivering the food and coming to take blood samples and every other interaction that the patients had with our team. I think they really felt that enthusiasm for being there and supporting our neighbors in LA [Los Angeles].”
Crew life aboard the Mercy
Just as with any hospital on shore, personnel aboard the Mercy practiced preventive hygiene measures recommended by the Centers for Disease Control and Prevention to help prevent the spread of COVID-19, such as wearing cloth face masks, spacing out tables in the dining hall, closing indoor gyms, and devising creative ways to stay physically fit. Popular options included jogging around the perimeter of the ship and practicing yoga and calisthenics on the deck, “making sure you were physically distanced appropriately, and when you were done, putting your mask back on,” Cdr. Blevins said. Others supplemented their workouts with a pull-up bar on the deck. “In addition, we have a series of ramps that run on the starboard side of the ship that we can use for patient movement with litters on wheels or patient beds,” Capt. Rotruck said. “The uphill portion of those ramps represents a good workout opportunity as well.”
Downtime in an era of physical distancing also afforded crew members the opportunity to call or FaceTime with loved ones, watch streamed TV shows and movies, and work on their own professional development. Some continued with coursework for online degree programs offered by colleges and universities they were enrolled in, while some enlisted personnel used the time to complete the Navy Enlisted Warfare Qualification Programs Instruction, which issues the basic overarching requirements for the qualification and designation of all enlisted warfare programs.
“As you can imagine, people spend a lot of time learning how the ship works and how it integrates into larger naval forces and so forth,” Capt. Rotruck said. “Not just our ship but also other ships: their weapons systems and defense mechanisms and navigation systems. We had people spending a significant amount of time working on that. We had people complete their Enlisted Surface Warfare qualification while we were on the mission.”
End of the mission
Mercy returned to its home base in San Diego on May 15, but about 60 medical personnel stayed behind in Los Angeles to support Federal Emergency Management Agency (FEMA), state, and local health care professionals. Some worked at a site where clinicians provided care for COVID-19–positive patients who had been transferred from area skilled nursing facilities.
In addition, a team consisting of one nurse and five corpsmen “would go out to individual skilled nursing facilities and mainly conduct assessments and training, such as training in donning proper PPE [personal protective equipment] and determining what needs they had,” Capt. Rotruck said. “They met those needs if possible or [communicated with California officials] and let them know what the requirements were and what the needs were in that facility.” The assignment for those who stayed behind ended on May 31.
On the opposite coast, Mercy’s sister ship, USNS Comfort, arrived in New York Harbor from Norfolk, Va., on March 30 and spent 3½ weeks assisting area hospitals in the COVID-19 pandemic fight. A few days into the mission, Comfort’s internal spaces were reconfigured to create separate COVID-negative and COVID-positive sections. Medical teams aboard the ship cared for a total of 182 patients during the assignment.
Looking back on Mercy’s mission, Cdr. Blevins marveled at the sense of teamwork that unfolded. “We have quarterly training exercises with a core set of personnel, [and] we train getting ready for activation in 5 days,” she said. “All of that training kicks in and it comes to fruition in a mission like this. It was terrific to see a group of very disparate subject matter experts from all over the country come together with one purpose: which was to serve our own country during the pandemic.”
Capt. Rotruck pointed out that the experience enabled enlisted and nonenlisted physicians to maintain their skill sets during a time when military and civilian hospitals had stopped doing elective procedures and routine appointments. “The fact that those people were able to come on board the ship and continue to conduct their medical practice and maintain their skills and competencies in an environment that they weren’t quite used to is great,” he said. “Otherwise, some of those medical personnel would have been sitting idle, wherever they were from. This is the power of Navy medicine on behalf of our country.”
Guidance on infection prevention for health care personnel
As we reopen our offices we are faced with the challenge of determining the best way to do it safely – protecting ourselves, our staff, and our patients.
In this column we will focus on selected details of the recommendations from IDSA and the CDC that may be helpful in primary care offices.
Face masks
Many clinicians have asked whether a physician should use a mask while seeing patients without COVID-19 in the office, and if yes, which type. The IDSA guideline states that mask usage is imperative for reducing the risk of health care workers contracting COVID-19.1 The evidence is derived from a number of sources, including a retrospective study from Wuhan (China) University that examined two groups of health care workers during the outbreak. The first group wore N95 masks and washed their hands frequently, while the second group did not wear masks and washed their hands less frequently. In the group that took greater actions to protect themselves, none of the 493 staff members contracted COVID-19, compared with 10 of 213 staff members in the other group. The decrease in infection rate occurred in the group that wore masks despite the fact that this group had 733% more exposure to COVID-19 patients.2 Further evidence came from a case-control study done in hospitals in Hong Kong during the 2003 SARS-CoV outbreak.3 This study showed that mask wearing was the most significant intervention for reducing infection, followed by gowning, and then handwashing. These findings make it clear that mask usage is a must for all health care providers who may be caring for patients who could have COVID-19.
The guideline also reviews evidence about the use of surgical masks versus N95 masks. On reviewing indirect evidence from the SARS-CoV epidemic, IDSA found that wearing any mask – surgical or N95 – led to a large reduction in the risk of developing an infection. In this systematic review of five observational studies in health care personnel, for those wearing surgical masks, the odds ratio for developing an infection was 0.13 (95% CI, 0.03-0.62), and for those wearing N95 masks, the odds ratio was 0.12 (95% CI, 0.06-0.26). There was not a significant difference between risk reductions for those who wore surgical masks and N95 masks, respectively.1,4 The IDSA guideline panel recommended “that health care personnel caring for patients with suspected or known COVID-19 use either a surgical mask or N95 respirator ... as part of appropriate PPE.” Since there is not a significant difference in outcomes between those who use surgical masks and those who use N95 respirators, and the IDSA guideline states either type of mask is considered appropriate when taking care of patients with suspected or known COVID-19, in our opinion, use of surgical masks rather than N95s is sufficient when performing low-risk activities. Such activities include seeing patients who do not have a high likelihood of COVID-19 in the office setting.
The IDSA recommendation also discusses universal masking, defined as both patients and clinicians wearing masks. The recommendation is supported by the findings of a study in which universal mask usage was used to prevent the spread of H1N 1 during the 2009 outbreak. In this study of staff members and patients exposed to H1N1 who all wore masks, only 0.48% of 836 acquired infection. In the same study, not wearing a mask by either the provider or patient increased the risk of infection.5 Also, in a prospective study of hematopoietic stem cell transplant patients, universal masking caused infection rates to drop from 10.3% to 4.4%.6
The IDSA guideline states the following: “There may be some, albeit uncertain, benefit to universal masking in the absence of resource constraints. However, the benefits of universal masking with surgical masks should be weighed against the risk of increasing the PPE burn rate and contextualized to the background COVID-19 prevalence rate for asymptomatic or minimally symptomatic HCPs [health care providers] and visitors.”1
The CDC’s guidance statement says the following: “Continued community transmission has increased the number of individuals potentially exposed to and infectious with SARS-CoV-2. Fever and symptom screening have proven to be relatively ineffective in identifying all infected individuals, including HCPs. Symptom screening also will not identify individuals who are infected but otherwise asymptomatic or pre-symptomatic; additional interventions are needed to limit the unrecognized introduction of SARS-CoV-2 into healthcare settings by these individuals. As part of aggressive source control measures, healthcare facilities should consider implementing policies requiring everyone entering the facility to wear a cloth face covering (if tolerated) while in the building, regardless of symptoms.”7
It is our opinion, based on the CDC and IDSA recommendations, that both clinicians and patients should be required to wear masks when patients are seen in the office if possible. Many offices have instituted a policy that says, if a patient refuses to wear a mask during an office visit, then the patient will not be seen.
Eye protection
Many clinicians are uncertain about whether eye protection needs to be used when seeing asymptomatic patients. The IDSA acknowledges that there are not studies that have looked critically at eye protection, but the society also acknowledges “appropriate personal protective equipment includes, in addition to a mask or respirator, eye protection, gown and gloves.”1 In addition, the CDC recommends that, for healthcare workers located in areas with moderate or higher prevalence of COVID-19, HCPs should wear eye protection in addition to facemasks since they may encounter asymptomatic individuals with COVID-19.
Gowns and gloves
Gowns and gloves are recommended as a part of personal protective gear when caring for patients who have COVID-19. The IDSA guideline is clear in its recommendations, but does not cite evidence for having no gloves versus having gloves. Furthermore, they state that the evidence is insufficient to recommend double gloves, with the top glove used to take off a personal protective gown, and the inner glove discarded after the gown is removed. The CDC do not make recommendations for routine use of gloves in the care of patients who do not have COVID-19, even in areas where there may be asymptomatic COVID-19, and recommends standard precautions, specifically practicing hand hygiene before and after patient contact.8
The Bottom Line
When seeing patients with COVID-19, N-95 masks, goggles or face shields, gowns, and gloves should be used, with hand hygiene routinely practiced before and after seeing patients. For offices seeing patients not suspected of having COVID-19, the IDSA guideline clarifies that there is not a statistical difference in acquisition of infection with the use of surgical face masks vs N95 respirators. According to the CDC recommendations, eye protection in addition to facemasks should be used by the health care provider, and masks should be worn by patients. Hand hygiene should be used routinely before and after all patient contact. With use of these approaches, it should be safe for offices to reopen and see patients.
Neil Skolnik, MD, is professor of family and community medicine at the Thomas Jefferson University, Philadelphia, and associate director of the Family Medicine Residency Program at Abington (Pa.) Jefferson Health. Jeffrey Matthews, DO, is a second-year resident in the Family Medicine Residency at Abington Jefferson Health. For questions or comments, feel free to contact Dr. Skolnik on Twitter @NeilSkolnik.
References
1. Lynch JB, Davitkov P, Anderson DJ, et al. COVID-19 Guideline, Part 2: Infection Prevention. IDSA Home. https://www.idsociety.org/practice-guideline/covid-19-guideline-infection-prevention/. April 27, 2020. Accessed June 10, 2020.
2. J Hosp Infect. 2020 May;105(1):104-5.
3. Lancet. 2003;361(9368):1519-20.
4. Influenza Other Respir Viruses. 2020 Apr 4. doi: 2020;10.1111/irv.12745.
5. J Hosp Infect. 2010;74(3):271-7.
6. Clin Infect Dis. 2016;63(8):999-1006.
7. Centers for Disease Control and Prevention. Interim Infection Prevention and Control Recommendations for Patients with Suspected or Confirmed Coronavirus Disease 2019 (COVID-19) in Healthcare Settings. https://www.cdc.gov/coronavirus/2019-ncov/hcp/infection-control-recommendations.html. Accessed Jun 16, 2020.
8. Centers for Disease Control and Prevention. Healthcare Infection Prevention and Control FAQs for COVID-19. https://www.cdc.gov/coronavirus/2019-ncov/hcp/infection-control-faq.html. Accessed June 15, 2020.
As we reopen our offices we are faced with the challenge of determining the best way to do it safely – protecting ourselves, our staff, and our patients.
In this column we will focus on selected details of the recommendations from IDSA and the CDC that may be helpful in primary care offices.
Face masks
Many clinicians have asked whether a physician should use a mask while seeing patients without COVID-19 in the office, and if yes, which type. The IDSA guideline states that mask usage is imperative for reducing the risk of health care workers contracting COVID-19.1 The evidence is derived from a number of sources, including a retrospective study from Wuhan (China) University that examined two groups of health care workers during the outbreak. The first group wore N95 masks and washed their hands frequently, while the second group did not wear masks and washed their hands less frequently. In the group that took greater actions to protect themselves, none of the 493 staff members contracted COVID-19, compared with 10 of 213 staff members in the other group. The decrease in infection rate occurred in the group that wore masks despite the fact that this group had 733% more exposure to COVID-19 patients.2 Further evidence came from a case-control study done in hospitals in Hong Kong during the 2003 SARS-CoV outbreak.3 This study showed that mask wearing was the most significant intervention for reducing infection, followed by gowning, and then handwashing. These findings make it clear that mask usage is a must for all health care providers who may be caring for patients who could have COVID-19.
The guideline also reviews evidence about the use of surgical masks versus N95 masks. On reviewing indirect evidence from the SARS-CoV epidemic, IDSA found that wearing any mask – surgical or N95 – led to a large reduction in the risk of developing an infection. In this systematic review of five observational studies in health care personnel, for those wearing surgical masks, the odds ratio for developing an infection was 0.13 (95% CI, 0.03-0.62), and for those wearing N95 masks, the odds ratio was 0.12 (95% CI, 0.06-0.26). There was not a significant difference between risk reductions for those who wore surgical masks and N95 masks, respectively.1,4 The IDSA guideline panel recommended “that health care personnel caring for patients with suspected or known COVID-19 use either a surgical mask or N95 respirator ... as part of appropriate PPE.” Since there is not a significant difference in outcomes between those who use surgical masks and those who use N95 respirators, and the IDSA guideline states either type of mask is considered appropriate when taking care of patients with suspected or known COVID-19, in our opinion, use of surgical masks rather than N95s is sufficient when performing low-risk activities. Such activities include seeing patients who do not have a high likelihood of COVID-19 in the office setting.
The IDSA recommendation also discusses universal masking, defined as both patients and clinicians wearing masks. The recommendation is supported by the findings of a study in which universal mask usage was used to prevent the spread of H1N 1 during the 2009 outbreak. In this study of staff members and patients exposed to H1N1 who all wore masks, only 0.48% of 836 acquired infection. In the same study, not wearing a mask by either the provider or patient increased the risk of infection.5 Also, in a prospective study of hematopoietic stem cell transplant patients, universal masking caused infection rates to drop from 10.3% to 4.4%.6
The IDSA guideline states the following: “There may be some, albeit uncertain, benefit to universal masking in the absence of resource constraints. However, the benefits of universal masking with surgical masks should be weighed against the risk of increasing the PPE burn rate and contextualized to the background COVID-19 prevalence rate for asymptomatic or minimally symptomatic HCPs [health care providers] and visitors.”1
The CDC’s guidance statement says the following: “Continued community transmission has increased the number of individuals potentially exposed to and infectious with SARS-CoV-2. Fever and symptom screening have proven to be relatively ineffective in identifying all infected individuals, including HCPs. Symptom screening also will not identify individuals who are infected but otherwise asymptomatic or pre-symptomatic; additional interventions are needed to limit the unrecognized introduction of SARS-CoV-2 into healthcare settings by these individuals. As part of aggressive source control measures, healthcare facilities should consider implementing policies requiring everyone entering the facility to wear a cloth face covering (if tolerated) while in the building, regardless of symptoms.”7
It is our opinion, based on the CDC and IDSA recommendations, that both clinicians and patients should be required to wear masks when patients are seen in the office if possible. Many offices have instituted a policy that says, if a patient refuses to wear a mask during an office visit, then the patient will not be seen.
Eye protection
Many clinicians are uncertain about whether eye protection needs to be used when seeing asymptomatic patients. The IDSA acknowledges that there are not studies that have looked critically at eye protection, but the society also acknowledges “appropriate personal protective equipment includes, in addition to a mask or respirator, eye protection, gown and gloves.”1 In addition, the CDC recommends that, for healthcare workers located in areas with moderate or higher prevalence of COVID-19, HCPs should wear eye protection in addition to facemasks since they may encounter asymptomatic individuals with COVID-19.
Gowns and gloves
Gowns and gloves are recommended as a part of personal protective gear when caring for patients who have COVID-19. The IDSA guideline is clear in its recommendations, but does not cite evidence for having no gloves versus having gloves. Furthermore, they state that the evidence is insufficient to recommend double gloves, with the top glove used to take off a personal protective gown, and the inner glove discarded after the gown is removed. The CDC do not make recommendations for routine use of gloves in the care of patients who do not have COVID-19, even in areas where there may be asymptomatic COVID-19, and recommends standard precautions, specifically practicing hand hygiene before and after patient contact.8
The Bottom Line
When seeing patients with COVID-19, N-95 masks, goggles or face shields, gowns, and gloves should be used, with hand hygiene routinely practiced before and after seeing patients. For offices seeing patients not suspected of having COVID-19, the IDSA guideline clarifies that there is not a statistical difference in acquisition of infection with the use of surgical face masks vs N95 respirators. According to the CDC recommendations, eye protection in addition to facemasks should be used by the health care provider, and masks should be worn by patients. Hand hygiene should be used routinely before and after all patient contact. With use of these approaches, it should be safe for offices to reopen and see patients.
Neil Skolnik, MD, is professor of family and community medicine at the Thomas Jefferson University, Philadelphia, and associate director of the Family Medicine Residency Program at Abington (Pa.) Jefferson Health. Jeffrey Matthews, DO, is a second-year resident in the Family Medicine Residency at Abington Jefferson Health. For questions or comments, feel free to contact Dr. Skolnik on Twitter @NeilSkolnik.
References
1. Lynch JB, Davitkov P, Anderson DJ, et al. COVID-19 Guideline, Part 2: Infection Prevention. IDSA Home. https://www.idsociety.org/practice-guideline/covid-19-guideline-infection-prevention/. April 27, 2020. Accessed June 10, 2020.
2. J Hosp Infect. 2020 May;105(1):104-5.
3. Lancet. 2003;361(9368):1519-20.
4. Influenza Other Respir Viruses. 2020 Apr 4. doi: 2020;10.1111/irv.12745.
5. J Hosp Infect. 2010;74(3):271-7.
6. Clin Infect Dis. 2016;63(8):999-1006.
7. Centers for Disease Control and Prevention. Interim Infection Prevention and Control Recommendations for Patients with Suspected or Confirmed Coronavirus Disease 2019 (COVID-19) in Healthcare Settings. https://www.cdc.gov/coronavirus/2019-ncov/hcp/infection-control-recommendations.html. Accessed Jun 16, 2020.
8. Centers for Disease Control and Prevention. Healthcare Infection Prevention and Control FAQs for COVID-19. https://www.cdc.gov/coronavirus/2019-ncov/hcp/infection-control-faq.html. Accessed June 15, 2020.
As we reopen our offices we are faced with the challenge of determining the best way to do it safely – protecting ourselves, our staff, and our patients.
In this column we will focus on selected details of the recommendations from IDSA and the CDC that may be helpful in primary care offices.
Face masks
Many clinicians have asked whether a physician should use a mask while seeing patients without COVID-19 in the office, and if yes, which type. The IDSA guideline states that mask usage is imperative for reducing the risk of health care workers contracting COVID-19.1 The evidence is derived from a number of sources, including a retrospective study from Wuhan (China) University that examined two groups of health care workers during the outbreak. The first group wore N95 masks and washed their hands frequently, while the second group did not wear masks and washed their hands less frequently. In the group that took greater actions to protect themselves, none of the 493 staff members contracted COVID-19, compared with 10 of 213 staff members in the other group. The decrease in infection rate occurred in the group that wore masks despite the fact that this group had 733% more exposure to COVID-19 patients.2 Further evidence came from a case-control study done in hospitals in Hong Kong during the 2003 SARS-CoV outbreak.3 This study showed that mask wearing was the most significant intervention for reducing infection, followed by gowning, and then handwashing. These findings make it clear that mask usage is a must for all health care providers who may be caring for patients who could have COVID-19.
The guideline also reviews evidence about the use of surgical masks versus N95 masks. On reviewing indirect evidence from the SARS-CoV epidemic, IDSA found that wearing any mask – surgical or N95 – led to a large reduction in the risk of developing an infection. In this systematic review of five observational studies in health care personnel, for those wearing surgical masks, the odds ratio for developing an infection was 0.13 (95% CI, 0.03-0.62), and for those wearing N95 masks, the odds ratio was 0.12 (95% CI, 0.06-0.26). There was not a significant difference between risk reductions for those who wore surgical masks and N95 masks, respectively.1,4 The IDSA guideline panel recommended “that health care personnel caring for patients with suspected or known COVID-19 use either a surgical mask or N95 respirator ... as part of appropriate PPE.” Since there is not a significant difference in outcomes between those who use surgical masks and those who use N95 respirators, and the IDSA guideline states either type of mask is considered appropriate when taking care of patients with suspected or known COVID-19, in our opinion, use of surgical masks rather than N95s is sufficient when performing low-risk activities. Such activities include seeing patients who do not have a high likelihood of COVID-19 in the office setting.
The IDSA recommendation also discusses universal masking, defined as both patients and clinicians wearing masks. The recommendation is supported by the findings of a study in which universal mask usage was used to prevent the spread of H1N 1 during the 2009 outbreak. In this study of staff members and patients exposed to H1N1 who all wore masks, only 0.48% of 836 acquired infection. In the same study, not wearing a mask by either the provider or patient increased the risk of infection.5 Also, in a prospective study of hematopoietic stem cell transplant patients, universal masking caused infection rates to drop from 10.3% to 4.4%.6
The IDSA guideline states the following: “There may be some, albeit uncertain, benefit to universal masking in the absence of resource constraints. However, the benefits of universal masking with surgical masks should be weighed against the risk of increasing the PPE burn rate and contextualized to the background COVID-19 prevalence rate for asymptomatic or minimally symptomatic HCPs [health care providers] and visitors.”1
The CDC’s guidance statement says the following: “Continued community transmission has increased the number of individuals potentially exposed to and infectious with SARS-CoV-2. Fever and symptom screening have proven to be relatively ineffective in identifying all infected individuals, including HCPs. Symptom screening also will not identify individuals who are infected but otherwise asymptomatic or pre-symptomatic; additional interventions are needed to limit the unrecognized introduction of SARS-CoV-2 into healthcare settings by these individuals. As part of aggressive source control measures, healthcare facilities should consider implementing policies requiring everyone entering the facility to wear a cloth face covering (if tolerated) while in the building, regardless of symptoms.”7
It is our opinion, based on the CDC and IDSA recommendations, that both clinicians and patients should be required to wear masks when patients are seen in the office if possible. Many offices have instituted a policy that says, if a patient refuses to wear a mask during an office visit, then the patient will not be seen.
Eye protection
Many clinicians are uncertain about whether eye protection needs to be used when seeing asymptomatic patients. The IDSA acknowledges that there are not studies that have looked critically at eye protection, but the society also acknowledges “appropriate personal protective equipment includes, in addition to a mask or respirator, eye protection, gown and gloves.”1 In addition, the CDC recommends that, for healthcare workers located in areas with moderate or higher prevalence of COVID-19, HCPs should wear eye protection in addition to facemasks since they may encounter asymptomatic individuals with COVID-19.
Gowns and gloves
Gowns and gloves are recommended as a part of personal protective gear when caring for patients who have COVID-19. The IDSA guideline is clear in its recommendations, but does not cite evidence for having no gloves versus having gloves. Furthermore, they state that the evidence is insufficient to recommend double gloves, with the top glove used to take off a personal protective gown, and the inner glove discarded after the gown is removed. The CDC do not make recommendations for routine use of gloves in the care of patients who do not have COVID-19, even in areas where there may be asymptomatic COVID-19, and recommends standard precautions, specifically practicing hand hygiene before and after patient contact.8
The Bottom Line
When seeing patients with COVID-19, N-95 masks, goggles or face shields, gowns, and gloves should be used, with hand hygiene routinely practiced before and after seeing patients. For offices seeing patients not suspected of having COVID-19, the IDSA guideline clarifies that there is not a statistical difference in acquisition of infection with the use of surgical face masks vs N95 respirators. According to the CDC recommendations, eye protection in addition to facemasks should be used by the health care provider, and masks should be worn by patients. Hand hygiene should be used routinely before and after all patient contact. With use of these approaches, it should be safe for offices to reopen and see patients.
Neil Skolnik, MD, is professor of family and community medicine at the Thomas Jefferson University, Philadelphia, and associate director of the Family Medicine Residency Program at Abington (Pa.) Jefferson Health. Jeffrey Matthews, DO, is a second-year resident in the Family Medicine Residency at Abington Jefferson Health. For questions or comments, feel free to contact Dr. Skolnik on Twitter @NeilSkolnik.
References
1. Lynch JB, Davitkov P, Anderson DJ, et al. COVID-19 Guideline, Part 2: Infection Prevention. IDSA Home. https://www.idsociety.org/practice-guideline/covid-19-guideline-infection-prevention/. April 27, 2020. Accessed June 10, 2020.
2. J Hosp Infect. 2020 May;105(1):104-5.
3. Lancet. 2003;361(9368):1519-20.
4. Influenza Other Respir Viruses. 2020 Apr 4. doi: 2020;10.1111/irv.12745.
5. J Hosp Infect. 2010;74(3):271-7.
6. Clin Infect Dis. 2016;63(8):999-1006.
7. Centers for Disease Control and Prevention. Interim Infection Prevention and Control Recommendations for Patients with Suspected or Confirmed Coronavirus Disease 2019 (COVID-19) in Healthcare Settings. https://www.cdc.gov/coronavirus/2019-ncov/hcp/infection-control-recommendations.html. Accessed Jun 16, 2020.
8. Centers for Disease Control and Prevention. Healthcare Infection Prevention and Control FAQs for COVID-19. https://www.cdc.gov/coronavirus/2019-ncov/hcp/infection-control-faq.html. Accessed June 15, 2020.
ACR issues guidances for MIS-C and pediatric rheumatic disease during pandemic
Two new clinical guidance documents from the American College of Rheumatology provide evidence-based recommendations for managing pediatric rheumatic disease during the COVID-19 pandemic as well as diagnostic and treatment recommendations for multisystem inflammatory syndrome in children (MIS-C) associated with COVID-19 infection.
Although several children’s hospitals have published their treatment protocols for MIS-C since the condition’s initial discovery, the ACR appears to be the first medical organization to review all the most current evidence to issue interim guidance with the expectations that it will change as more data become available.
“It is challenging having to make recommendations not having a lot of scientific evidence, but we still felt we had to use whatever’s out there to the best of our ability and use our experience to put together these recommendations,” Dawn M. Wahezi, MD, chief of pediatric rheumatology at Children’s Hospital at Montefiore and an associate professor of pediatrics at Albert Einstein College of Medicine, New York, said in an interview.
“We wanted to be mindful of the fact that there are things we know and things we don’t know, and we have to be careful about what we’re recommending,” said Dr. Wahezi, a member of the ACR working group that assembled the recommendations for pediatric rheumatic disease management during the pandemic. “We’re recommending the best we can at this moment, but if there are new studies that come out and suggest otherwise, we will definitely have to go back and amend the document.”
The foremost priority of the pediatric rheumatic disease guidance focuses on maintaining control of the disease and avoiding flares that may put children at greater risk of infection. Dr. Wahezi said the ACR has received many calls from patients and clinicians asking whether patients should continue their immunosuppressant medications. Fear of the coronavirus infection, medication shortages, difficulty getting to the pharmacy, uneasiness about going to the clinic or hospital for infusions, and other barriers may have led to gaps in medication.
“We didn’t want people to be too quick to hold patients’ medications just because they were scared of COVID,” Dr. Wahezi said. “If they did have medication stopped for one reason or another and their disease flared, having active disease, regardless of which disease it is, actually puts you at higher risk for infection. By controlling their disease, that would be the way to protect them the most.”
A key takeaway in the guidance on MIS-C, meanwhile, is an emphasis on its rarity lest physicians be too quick to diagnose it and miss another serious condition with overlapping symptoms, explained Lauren Henderson, MD, an attending rheumatologist at Boston Children’s Hospital and assistant professor of pediatrics at Harvard Medical School, Boston. Dr. Henderson participated in the ACR group that wrote the MIS-C guidance.
“The first thing we want to be thoughtful about clinically is to recognize that children in general with the acute infectious phase of SARS-CoV-2 have mild symptoms and generally do well,” Dr. Henderson said. “From what we can tell from all the data, MIS-C is rare. That really needs to be considered when clinicians on the ground are doing the diagnostic evaluation” because of concerns that clinicians “could rush to diagnose and treat patients with MIS-C and miss important diagnoses like malignancies and infections.”
Management of pediatric rheumatic disease during the pandemic
The COVID-19 clinical guidance for managing pediatric rheumatic disease grew from the work of the North American Pediatric Rheumatology Clinical Guidance Task Force, which included seven pediatric rheumatologists, two pediatric infectious disease physicians, one adult rheumatologist, and one pediatric nurse practitioner. The general guidance covers usual preventive measures for reducing risk for COVID-19 infection, the recommendation that children continue to receive recommended vaccines unless contraindicated by medication, and routine in-person visits for ophthalmologic surveillance of those with a history of uveitis or at high risk for chronic uveitis. The guidance also notes the risk of mental health concerns, such as depression and anxiety, related to quarantine and the pandemic.
The top recommendation is initiation or continuation of all medications necessary to control underlying disease, including NSAIDs, hydroxychloroquine, ACE inhibitors/angiotensin II receptor blockers, colchicine, conventional disease-modifying antirheumatic drugs (cDMARDs), biologic DMARDs, and targeted synthetic DMARDs. Even patients who may have had exposure to COVID-19 or who have an asymptomatic COVID-19 infection should continue to take these medications with the exception of ACEi/ARBs.
In those with pediatric rheumatic disease who have a symptomatic COVID-19 infection, “NSAIDs, HCQ, and colchicine may be continued, if necessary, to control underlying disease,” as can interleukin (IL)-1 and IL-6 inhibitors, but “cDMARDs, bDMARDs [except IL-1 and IL-6 inhibitors] and tsDMARDs should be temporarily delayed or withheld,” according to the guidance. Glucocorticoids can be continued at the lowest possible dose to control disease.
“There’s nothing in the literature that suggests people who have rheumatic disease, especially children, and people who are on these medications, really are at increased risk for COVID-19,” Dr. Wahezi said. “That’s why we didn’t want people to be overcautious in stopping medications when the main priority is to control their disease.”
She noted some experts’ speculations that these medications may actually benefit patients with rheumatic disease who develop a COVID-19 infection because the medications keep the immune response in check. “If you allow them to have this dysregulated immune response and have active disease, you’re potentially putting them at greater risk,” Dr. Wahezi said, although she stressed that inadequate evidence exists to support these speculations right now.
Lack of evidence has been the biggest challenge all around with developing this guidance, she said.
“Because this is such an unprecedented situation and because people are so desperate to find treatments both for the illness and to protect those at risk for it, there are lots of people trying to put evidence out there, but it may not be the best-quality evidence,” Dr. Wahezi said.
Insufficient evidence also drove the group’s determination that “SARS-CoV-2 antibody testing is not useful in informing on the history of infection or risk of reinfection,” as the guidance states. Too much variability in the assays exist, Dr. Wahezi said, and, further, it’s unclear what the clinical significance of a positive test would be.
“We didn’t want anyone to feel they had to make clinical decisions based on the results of that antibody testing,” she said. “Even if the test is accurate, we don’t know how to interpret it because it’s so new.”
The guidance also notes that patients with stable disease and previously stable lab markers on stable doses of their medication may be able to extend the interval for medication toxicity lab testing a few months if there is concern about exposure to COVID-19 to get the blood work.
“If you’re just starting a medicine or there’s someone who’s had abnormalities with the medicine in the past or you’re making medication adjustments, you wouldn’t do it in those scenarios, but if there’s someone who’s been on the drug for a long time and are nervous to get [blood] drawn, it’s probably okay to delay it,” Dr. Wahezi said. Lab work for disease activity measures, on the other hand, remain particularly important, especially since telemedicine visits may require clinicians to rely on lab results more than previously.
Management of MIS-C associated with COVID-19
The task force that developed guidance for the new inflammatory condition recently linked to SARS-CoV-2 infections in children included nine pediatric rheumatologists, two adult rheumatologists, two pediatric cardiologists, two pediatric infectious disease specialists, and one pediatric critical care physician.
The guidance includes a figure for the diagnostic pathway in evaluating children suspected of having MIS-C and extensive detail on diagnostic work-up, but the task force intentionally avoided providing a case definition for the condition. Existing case definitions from the Centers for Disease Control and Prevention, World Health Organization, and the United Kingdom’s Royal College of Paediatrics and Child Health differ from one another and are based on unclear evidence, Dr. Henderson noted. “We really don’t have enough data to know the sensitivity and specificity of each parameter, and until that’s available, we didn’t want to add to the confusion,” she said.
The guidance also stresses that MIS-C is a rare complication, so patients suspected of having the condition who do not have “life-threatening manifestations should undergo diagnostic evaluation for MIS-C as well as other possible infectious and noninfectious etiologies before immunomodulatory treatment is initiated,” the guidance states.
Unless a child is in shock or otherwise requires urgent care, physicians should take the time to complete the diagnostic work-up while monitoring the child, Dr. Henderson said. If the child does have MIS-C, the guidance currently recommends intravenous immunoglobulin (IVIG) and/or glucocorticoids to prevent coronary artery aneurysms, the same treatment other institutions have been recommending.
“We don’t have rigorous comparative studies looking at different types of treatments,” Dr. Henderson said, noting that the vast majority of children in the literature received IVIG and/or glucocorticoid treatment. “Often children really responded quite forcefully to those treatments, but we don’t have high-quality data yet to know that this treatment is better than supportive care or another medication.”
Dr. Henderson also stressed the importance of children receiving care at a facility with the necessary expertise to manage MIS-C and receiving long-term follow-up care from a multidisciplinary clinical team that includes a rheumatologist, an infectious disease doctor, a cardiologist, and possibly a hematologist.
“Making sure children are admitted to a hospital that has the resources and are followed by physicians with expertise or understanding of the intricacies of MIS-C is really important,” she said, particularly for children with cardiac involvement. “We don’t know if all the kids presenting with left ventricular dysfunction and shock are at risk for having myocardial fibrosis down the line,” she noted. “There is so much we do not understand and very little data to guide us on what to do, so these children really need to be under the care of a cardiologist and rheumatologist to make sure that their care is tailored to them.”
Although MIS-C shares overlapping symptoms with Kawasaki disease, it’s still unclear how similar or different the two conditions are, Dr. Henderson said.
“We can definitely say that when we look at MIS-C and compare it to historical groups of Kawasaki disease before the pandemic, there are definitely different features in the MIS-C group,” she said. Kawasaki disease generally only affects children under age 5, whereas MIS-C patients run the gamut from age 1-17. Racial demographics are also different, with a higher proportion of black children affected by MIS-C.
It’s possible that the pathophysiology of both conditions will turn out to be similar, particularly given the hypothesis that Kawasaki disease is triggered by infections in genetically predisposed people. However, the severity of symptoms and risk of aneurysms appear greater with MIS-C so far.
“The degree to which these patients are presenting with left ventricular dysfunction and shock is much higher than what we’ve seen previously,” Dr. Henderson said. “Children can have aneurysms even if they don’t meet all the Kawasaki disease features, which makes it feel that this is somehow clinically different from what we’ve seen before. It’s not just the kids who have the rash and the conjunctivitis and the extremity changes and oral changes who have the aneurysms.”
The reason for including both IVIG and glucocorticoids as possible first-line drugs to prevent aneurysms is that some evidence suggests children with MIS-C may have higher levels of IVIG resistance, she said.
Like Dr. Wahezi, Dr. Henderson emphasized the necessarily transient nature of these recommendations.
“These recommendations will almost certainly change based on evolving understanding of MIS-C and the data,” Dr. Henderson said, adding that this new, unique condition highlights the importance of including children in allocating funding for research and in clinical trials.
“Children are not always identical to adults, and it’s really important that we have high-quality data to inform our decisions about how to care for them,” she said.
Dr. Wahezi had no disclosures. Dr. Henderson has consulted for Sobi and Adaptive Technologies. The guidelines did not note other disclosures for members of the ACR groups.
SOURCES: COVID-19 Clinical Guidance for Pediatric Patients with Rheumatic Disease and Clinical Guidance for Pediatric Patients with Multisystem Inflammatory Syndrome in Children (MIS-C) Associated with SARS-CoV-2 and Hyperinflammation in COVID-19
Two new clinical guidance documents from the American College of Rheumatology provide evidence-based recommendations for managing pediatric rheumatic disease during the COVID-19 pandemic as well as diagnostic and treatment recommendations for multisystem inflammatory syndrome in children (MIS-C) associated with COVID-19 infection.
Although several children’s hospitals have published their treatment protocols for MIS-C since the condition’s initial discovery, the ACR appears to be the first medical organization to review all the most current evidence to issue interim guidance with the expectations that it will change as more data become available.
“It is challenging having to make recommendations not having a lot of scientific evidence, but we still felt we had to use whatever’s out there to the best of our ability and use our experience to put together these recommendations,” Dawn M. Wahezi, MD, chief of pediatric rheumatology at Children’s Hospital at Montefiore and an associate professor of pediatrics at Albert Einstein College of Medicine, New York, said in an interview.
“We wanted to be mindful of the fact that there are things we know and things we don’t know, and we have to be careful about what we’re recommending,” said Dr. Wahezi, a member of the ACR working group that assembled the recommendations for pediatric rheumatic disease management during the pandemic. “We’re recommending the best we can at this moment, but if there are new studies that come out and suggest otherwise, we will definitely have to go back and amend the document.”
The foremost priority of the pediatric rheumatic disease guidance focuses on maintaining control of the disease and avoiding flares that may put children at greater risk of infection. Dr. Wahezi said the ACR has received many calls from patients and clinicians asking whether patients should continue their immunosuppressant medications. Fear of the coronavirus infection, medication shortages, difficulty getting to the pharmacy, uneasiness about going to the clinic or hospital for infusions, and other barriers may have led to gaps in medication.
“We didn’t want people to be too quick to hold patients’ medications just because they were scared of COVID,” Dr. Wahezi said. “If they did have medication stopped for one reason or another and their disease flared, having active disease, regardless of which disease it is, actually puts you at higher risk for infection. By controlling their disease, that would be the way to protect them the most.”
A key takeaway in the guidance on MIS-C, meanwhile, is an emphasis on its rarity lest physicians be too quick to diagnose it and miss another serious condition with overlapping symptoms, explained Lauren Henderson, MD, an attending rheumatologist at Boston Children’s Hospital and assistant professor of pediatrics at Harvard Medical School, Boston. Dr. Henderson participated in the ACR group that wrote the MIS-C guidance.
“The first thing we want to be thoughtful about clinically is to recognize that children in general with the acute infectious phase of SARS-CoV-2 have mild symptoms and generally do well,” Dr. Henderson said. “From what we can tell from all the data, MIS-C is rare. That really needs to be considered when clinicians on the ground are doing the diagnostic evaluation” because of concerns that clinicians “could rush to diagnose and treat patients with MIS-C and miss important diagnoses like malignancies and infections.”
Management of pediatric rheumatic disease during the pandemic
The COVID-19 clinical guidance for managing pediatric rheumatic disease grew from the work of the North American Pediatric Rheumatology Clinical Guidance Task Force, which included seven pediatric rheumatologists, two pediatric infectious disease physicians, one adult rheumatologist, and one pediatric nurse practitioner. The general guidance covers usual preventive measures for reducing risk for COVID-19 infection, the recommendation that children continue to receive recommended vaccines unless contraindicated by medication, and routine in-person visits for ophthalmologic surveillance of those with a history of uveitis or at high risk for chronic uveitis. The guidance also notes the risk of mental health concerns, such as depression and anxiety, related to quarantine and the pandemic.
The top recommendation is initiation or continuation of all medications necessary to control underlying disease, including NSAIDs, hydroxychloroquine, ACE inhibitors/angiotensin II receptor blockers, colchicine, conventional disease-modifying antirheumatic drugs (cDMARDs), biologic DMARDs, and targeted synthetic DMARDs. Even patients who may have had exposure to COVID-19 or who have an asymptomatic COVID-19 infection should continue to take these medications with the exception of ACEi/ARBs.
In those with pediatric rheumatic disease who have a symptomatic COVID-19 infection, “NSAIDs, HCQ, and colchicine may be continued, if necessary, to control underlying disease,” as can interleukin (IL)-1 and IL-6 inhibitors, but “cDMARDs, bDMARDs [except IL-1 and IL-6 inhibitors] and tsDMARDs should be temporarily delayed or withheld,” according to the guidance. Glucocorticoids can be continued at the lowest possible dose to control disease.
“There’s nothing in the literature that suggests people who have rheumatic disease, especially children, and people who are on these medications, really are at increased risk for COVID-19,” Dr. Wahezi said. “That’s why we didn’t want people to be overcautious in stopping medications when the main priority is to control their disease.”
She noted some experts’ speculations that these medications may actually benefit patients with rheumatic disease who develop a COVID-19 infection because the medications keep the immune response in check. “If you allow them to have this dysregulated immune response and have active disease, you’re potentially putting them at greater risk,” Dr. Wahezi said, although she stressed that inadequate evidence exists to support these speculations right now.
Lack of evidence has been the biggest challenge all around with developing this guidance, she said.
“Because this is such an unprecedented situation and because people are so desperate to find treatments both for the illness and to protect those at risk for it, there are lots of people trying to put evidence out there, but it may not be the best-quality evidence,” Dr. Wahezi said.
Insufficient evidence also drove the group’s determination that “SARS-CoV-2 antibody testing is not useful in informing on the history of infection or risk of reinfection,” as the guidance states. Too much variability in the assays exist, Dr. Wahezi said, and, further, it’s unclear what the clinical significance of a positive test would be.
“We didn’t want anyone to feel they had to make clinical decisions based on the results of that antibody testing,” she said. “Even if the test is accurate, we don’t know how to interpret it because it’s so new.”
The guidance also notes that patients with stable disease and previously stable lab markers on stable doses of their medication may be able to extend the interval for medication toxicity lab testing a few months if there is concern about exposure to COVID-19 to get the blood work.
“If you’re just starting a medicine or there’s someone who’s had abnormalities with the medicine in the past or you’re making medication adjustments, you wouldn’t do it in those scenarios, but if there’s someone who’s been on the drug for a long time and are nervous to get [blood] drawn, it’s probably okay to delay it,” Dr. Wahezi said. Lab work for disease activity measures, on the other hand, remain particularly important, especially since telemedicine visits may require clinicians to rely on lab results more than previously.
Management of MIS-C associated with COVID-19
The task force that developed guidance for the new inflammatory condition recently linked to SARS-CoV-2 infections in children included nine pediatric rheumatologists, two adult rheumatologists, two pediatric cardiologists, two pediatric infectious disease specialists, and one pediatric critical care physician.
The guidance includes a figure for the diagnostic pathway in evaluating children suspected of having MIS-C and extensive detail on diagnostic work-up, but the task force intentionally avoided providing a case definition for the condition. Existing case definitions from the Centers for Disease Control and Prevention, World Health Organization, and the United Kingdom’s Royal College of Paediatrics and Child Health differ from one another and are based on unclear evidence, Dr. Henderson noted. “We really don’t have enough data to know the sensitivity and specificity of each parameter, and until that’s available, we didn’t want to add to the confusion,” she said.
The guidance also stresses that MIS-C is a rare complication, so patients suspected of having the condition who do not have “life-threatening manifestations should undergo diagnostic evaluation for MIS-C as well as other possible infectious and noninfectious etiologies before immunomodulatory treatment is initiated,” the guidance states.
Unless a child is in shock or otherwise requires urgent care, physicians should take the time to complete the diagnostic work-up while monitoring the child, Dr. Henderson said. If the child does have MIS-C, the guidance currently recommends intravenous immunoglobulin (IVIG) and/or glucocorticoids to prevent coronary artery aneurysms, the same treatment other institutions have been recommending.
“We don’t have rigorous comparative studies looking at different types of treatments,” Dr. Henderson said, noting that the vast majority of children in the literature received IVIG and/or glucocorticoid treatment. “Often children really responded quite forcefully to those treatments, but we don’t have high-quality data yet to know that this treatment is better than supportive care or another medication.”
Dr. Henderson also stressed the importance of children receiving care at a facility with the necessary expertise to manage MIS-C and receiving long-term follow-up care from a multidisciplinary clinical team that includes a rheumatologist, an infectious disease doctor, a cardiologist, and possibly a hematologist.
“Making sure children are admitted to a hospital that has the resources and are followed by physicians with expertise or understanding of the intricacies of MIS-C is really important,” she said, particularly for children with cardiac involvement. “We don’t know if all the kids presenting with left ventricular dysfunction and shock are at risk for having myocardial fibrosis down the line,” she noted. “There is so much we do not understand and very little data to guide us on what to do, so these children really need to be under the care of a cardiologist and rheumatologist to make sure that their care is tailored to them.”
Although MIS-C shares overlapping symptoms with Kawasaki disease, it’s still unclear how similar or different the two conditions are, Dr. Henderson said.
“We can definitely say that when we look at MIS-C and compare it to historical groups of Kawasaki disease before the pandemic, there are definitely different features in the MIS-C group,” she said. Kawasaki disease generally only affects children under age 5, whereas MIS-C patients run the gamut from age 1-17. Racial demographics are also different, with a higher proportion of black children affected by MIS-C.
It’s possible that the pathophysiology of both conditions will turn out to be similar, particularly given the hypothesis that Kawasaki disease is triggered by infections in genetically predisposed people. However, the severity of symptoms and risk of aneurysms appear greater with MIS-C so far.
“The degree to which these patients are presenting with left ventricular dysfunction and shock is much higher than what we’ve seen previously,” Dr. Henderson said. “Children can have aneurysms even if they don’t meet all the Kawasaki disease features, which makes it feel that this is somehow clinically different from what we’ve seen before. It’s not just the kids who have the rash and the conjunctivitis and the extremity changes and oral changes who have the aneurysms.”
The reason for including both IVIG and glucocorticoids as possible first-line drugs to prevent aneurysms is that some evidence suggests children with MIS-C may have higher levels of IVIG resistance, she said.
Like Dr. Wahezi, Dr. Henderson emphasized the necessarily transient nature of these recommendations.
“These recommendations will almost certainly change based on evolving understanding of MIS-C and the data,” Dr. Henderson said, adding that this new, unique condition highlights the importance of including children in allocating funding for research and in clinical trials.
“Children are not always identical to adults, and it’s really important that we have high-quality data to inform our decisions about how to care for them,” she said.
Dr. Wahezi had no disclosures. Dr. Henderson has consulted for Sobi and Adaptive Technologies. The guidelines did not note other disclosures for members of the ACR groups.
SOURCES: COVID-19 Clinical Guidance for Pediatric Patients with Rheumatic Disease and Clinical Guidance for Pediatric Patients with Multisystem Inflammatory Syndrome in Children (MIS-C) Associated with SARS-CoV-2 and Hyperinflammation in COVID-19
Two new clinical guidance documents from the American College of Rheumatology provide evidence-based recommendations for managing pediatric rheumatic disease during the COVID-19 pandemic as well as diagnostic and treatment recommendations for multisystem inflammatory syndrome in children (MIS-C) associated with COVID-19 infection.
Although several children’s hospitals have published their treatment protocols for MIS-C since the condition’s initial discovery, the ACR appears to be the first medical organization to review all the most current evidence to issue interim guidance with the expectations that it will change as more data become available.
“It is challenging having to make recommendations not having a lot of scientific evidence, but we still felt we had to use whatever’s out there to the best of our ability and use our experience to put together these recommendations,” Dawn M. Wahezi, MD, chief of pediatric rheumatology at Children’s Hospital at Montefiore and an associate professor of pediatrics at Albert Einstein College of Medicine, New York, said in an interview.
“We wanted to be mindful of the fact that there are things we know and things we don’t know, and we have to be careful about what we’re recommending,” said Dr. Wahezi, a member of the ACR working group that assembled the recommendations for pediatric rheumatic disease management during the pandemic. “We’re recommending the best we can at this moment, but if there are new studies that come out and suggest otherwise, we will definitely have to go back and amend the document.”
The foremost priority of the pediatric rheumatic disease guidance focuses on maintaining control of the disease and avoiding flares that may put children at greater risk of infection. Dr. Wahezi said the ACR has received many calls from patients and clinicians asking whether patients should continue their immunosuppressant medications. Fear of the coronavirus infection, medication shortages, difficulty getting to the pharmacy, uneasiness about going to the clinic or hospital for infusions, and other barriers may have led to gaps in medication.
“We didn’t want people to be too quick to hold patients’ medications just because they were scared of COVID,” Dr. Wahezi said. “If they did have medication stopped for one reason or another and their disease flared, having active disease, regardless of which disease it is, actually puts you at higher risk for infection. By controlling their disease, that would be the way to protect them the most.”
A key takeaway in the guidance on MIS-C, meanwhile, is an emphasis on its rarity lest physicians be too quick to diagnose it and miss another serious condition with overlapping symptoms, explained Lauren Henderson, MD, an attending rheumatologist at Boston Children’s Hospital and assistant professor of pediatrics at Harvard Medical School, Boston. Dr. Henderson participated in the ACR group that wrote the MIS-C guidance.
“The first thing we want to be thoughtful about clinically is to recognize that children in general with the acute infectious phase of SARS-CoV-2 have mild symptoms and generally do well,” Dr. Henderson said. “From what we can tell from all the data, MIS-C is rare. That really needs to be considered when clinicians on the ground are doing the diagnostic evaluation” because of concerns that clinicians “could rush to diagnose and treat patients with MIS-C and miss important diagnoses like malignancies and infections.”
Management of pediatric rheumatic disease during the pandemic
The COVID-19 clinical guidance for managing pediatric rheumatic disease grew from the work of the North American Pediatric Rheumatology Clinical Guidance Task Force, which included seven pediatric rheumatologists, two pediatric infectious disease physicians, one adult rheumatologist, and one pediatric nurse practitioner. The general guidance covers usual preventive measures for reducing risk for COVID-19 infection, the recommendation that children continue to receive recommended vaccines unless contraindicated by medication, and routine in-person visits for ophthalmologic surveillance of those with a history of uveitis or at high risk for chronic uveitis. The guidance also notes the risk of mental health concerns, such as depression and anxiety, related to quarantine and the pandemic.
The top recommendation is initiation or continuation of all medications necessary to control underlying disease, including NSAIDs, hydroxychloroquine, ACE inhibitors/angiotensin II receptor blockers, colchicine, conventional disease-modifying antirheumatic drugs (cDMARDs), biologic DMARDs, and targeted synthetic DMARDs. Even patients who may have had exposure to COVID-19 or who have an asymptomatic COVID-19 infection should continue to take these medications with the exception of ACEi/ARBs.
In those with pediatric rheumatic disease who have a symptomatic COVID-19 infection, “NSAIDs, HCQ, and colchicine may be continued, if necessary, to control underlying disease,” as can interleukin (IL)-1 and IL-6 inhibitors, but “cDMARDs, bDMARDs [except IL-1 and IL-6 inhibitors] and tsDMARDs should be temporarily delayed or withheld,” according to the guidance. Glucocorticoids can be continued at the lowest possible dose to control disease.
“There’s nothing in the literature that suggests people who have rheumatic disease, especially children, and people who are on these medications, really are at increased risk for COVID-19,” Dr. Wahezi said. “That’s why we didn’t want people to be overcautious in stopping medications when the main priority is to control their disease.”
She noted some experts’ speculations that these medications may actually benefit patients with rheumatic disease who develop a COVID-19 infection because the medications keep the immune response in check. “If you allow them to have this dysregulated immune response and have active disease, you’re potentially putting them at greater risk,” Dr. Wahezi said, although she stressed that inadequate evidence exists to support these speculations right now.
Lack of evidence has been the biggest challenge all around with developing this guidance, she said.
“Because this is such an unprecedented situation and because people are so desperate to find treatments both for the illness and to protect those at risk for it, there are lots of people trying to put evidence out there, but it may not be the best-quality evidence,” Dr. Wahezi said.
Insufficient evidence also drove the group’s determination that “SARS-CoV-2 antibody testing is not useful in informing on the history of infection or risk of reinfection,” as the guidance states. Too much variability in the assays exist, Dr. Wahezi said, and, further, it’s unclear what the clinical significance of a positive test would be.
“We didn’t want anyone to feel they had to make clinical decisions based on the results of that antibody testing,” she said. “Even if the test is accurate, we don’t know how to interpret it because it’s so new.”
The guidance also notes that patients with stable disease and previously stable lab markers on stable doses of their medication may be able to extend the interval for medication toxicity lab testing a few months if there is concern about exposure to COVID-19 to get the blood work.
“If you’re just starting a medicine or there’s someone who’s had abnormalities with the medicine in the past or you’re making medication adjustments, you wouldn’t do it in those scenarios, but if there’s someone who’s been on the drug for a long time and are nervous to get [blood] drawn, it’s probably okay to delay it,” Dr. Wahezi said. Lab work for disease activity measures, on the other hand, remain particularly important, especially since telemedicine visits may require clinicians to rely on lab results more than previously.
Management of MIS-C associated with COVID-19
The task force that developed guidance for the new inflammatory condition recently linked to SARS-CoV-2 infections in children included nine pediatric rheumatologists, two adult rheumatologists, two pediatric cardiologists, two pediatric infectious disease specialists, and one pediatric critical care physician.
The guidance includes a figure for the diagnostic pathway in evaluating children suspected of having MIS-C and extensive detail on diagnostic work-up, but the task force intentionally avoided providing a case definition for the condition. Existing case definitions from the Centers for Disease Control and Prevention, World Health Organization, and the United Kingdom’s Royal College of Paediatrics and Child Health differ from one another and are based on unclear evidence, Dr. Henderson noted. “We really don’t have enough data to know the sensitivity and specificity of each parameter, and until that’s available, we didn’t want to add to the confusion,” she said.
The guidance also stresses that MIS-C is a rare complication, so patients suspected of having the condition who do not have “life-threatening manifestations should undergo diagnostic evaluation for MIS-C as well as other possible infectious and noninfectious etiologies before immunomodulatory treatment is initiated,” the guidance states.
Unless a child is in shock or otherwise requires urgent care, physicians should take the time to complete the diagnostic work-up while monitoring the child, Dr. Henderson said. If the child does have MIS-C, the guidance currently recommends intravenous immunoglobulin (IVIG) and/or glucocorticoids to prevent coronary artery aneurysms, the same treatment other institutions have been recommending.
“We don’t have rigorous comparative studies looking at different types of treatments,” Dr. Henderson said, noting that the vast majority of children in the literature received IVIG and/or glucocorticoid treatment. “Often children really responded quite forcefully to those treatments, but we don’t have high-quality data yet to know that this treatment is better than supportive care or another medication.”
Dr. Henderson also stressed the importance of children receiving care at a facility with the necessary expertise to manage MIS-C and receiving long-term follow-up care from a multidisciplinary clinical team that includes a rheumatologist, an infectious disease doctor, a cardiologist, and possibly a hematologist.
“Making sure children are admitted to a hospital that has the resources and are followed by physicians with expertise or understanding of the intricacies of MIS-C is really important,” she said, particularly for children with cardiac involvement. “We don’t know if all the kids presenting with left ventricular dysfunction and shock are at risk for having myocardial fibrosis down the line,” she noted. “There is so much we do not understand and very little data to guide us on what to do, so these children really need to be under the care of a cardiologist and rheumatologist to make sure that their care is tailored to them.”
Although MIS-C shares overlapping symptoms with Kawasaki disease, it’s still unclear how similar or different the two conditions are, Dr. Henderson said.
“We can definitely say that when we look at MIS-C and compare it to historical groups of Kawasaki disease before the pandemic, there are definitely different features in the MIS-C group,” she said. Kawasaki disease generally only affects children under age 5, whereas MIS-C patients run the gamut from age 1-17. Racial demographics are also different, with a higher proportion of black children affected by MIS-C.
It’s possible that the pathophysiology of both conditions will turn out to be similar, particularly given the hypothesis that Kawasaki disease is triggered by infections in genetically predisposed people. However, the severity of symptoms and risk of aneurysms appear greater with MIS-C so far.
“The degree to which these patients are presenting with left ventricular dysfunction and shock is much higher than what we’ve seen previously,” Dr. Henderson said. “Children can have aneurysms even if they don’t meet all the Kawasaki disease features, which makes it feel that this is somehow clinically different from what we’ve seen before. It’s not just the kids who have the rash and the conjunctivitis and the extremity changes and oral changes who have the aneurysms.”
The reason for including both IVIG and glucocorticoids as possible first-line drugs to prevent aneurysms is that some evidence suggests children with MIS-C may have higher levels of IVIG resistance, she said.
Like Dr. Wahezi, Dr. Henderson emphasized the necessarily transient nature of these recommendations.
“These recommendations will almost certainly change based on evolving understanding of MIS-C and the data,” Dr. Henderson said, adding that this new, unique condition highlights the importance of including children in allocating funding for research and in clinical trials.
“Children are not always identical to adults, and it’s really important that we have high-quality data to inform our decisions about how to care for them,” she said.
Dr. Wahezi had no disclosures. Dr. Henderson has consulted for Sobi and Adaptive Technologies. The guidelines did not note other disclosures for members of the ACR groups.
SOURCES: COVID-19 Clinical Guidance for Pediatric Patients with Rheumatic Disease and Clinical Guidance for Pediatric Patients with Multisystem Inflammatory Syndrome in Children (MIS-C) Associated with SARS-CoV-2 and Hyperinflammation in COVID-19
Risankizumab compared with secukinumab in 52-week psoriasis trial
.
Risankizumab was better tolerated, with a significantly lower rate of treatment-emergent adverse events and a lower study dropout rate, Richard B. Warren, MBChB, PhD, reported at the virtual annual meeting of the American Academy of Dermatology.
In addition, the dosing schedule for risankizumab (Skyrizi) is more convenient, with maintenance dosing by subcutaneous injection once every 12 weeks, compared with monthly for secukinumab (Cosentyx), a biologic for psoriasis considered state-of-the-art not long ago, noted Dr. Warren, a dermatologist at the Salford (England) Royal NHS Foundation Trust and the Manchester NIHR Biomedical Research Center as well as professor of dermatology at the University of Manchester.
The phase 3 IMMERGE trial included 327 patients with moderate to severe psoriasis randomized to risankizumab or secukinumab for 52 weeks at their approved dosing. The trial, conducted mainly in the United States, Canada, and Europe, was open label, but evaluator blinded.
The coprimary endpoints were a 90% improvement from baseline in Psoriasis Area and Severity Index scores (PASI 90) at weeks 16 and 52. The week 52 PASI 90 response rates were 87% in the risankizumab group and 57% with secukinumab, for a highly significant absolute 30% difference. The week 16 result was a prespecified noninferiority analysis, and here again risankizumab met its mark, with a PASI 90 rate of 74%, statistically noninferior to the 66% rate with secukinumab, even though at that point patients had received only two doses of risankizumab, versus seven doses of secukinumab.
The PASI 100 response rate at 52 weeks, a key secondary endpoint, was 66% with risankizumab and 40% with secukinumab. Another secondary endpoint was achievement of a static Physician Global Assessment score of 0 or 1 – clear or almost clear – at week 52; the rates were 88% with risankizumab, 58% with secukinumab.
Ninety-two percent of participants randomized to risankizumab completed the full 52-week study, as did 82.8% of the secukinumab group. The nearly 10% absolute lower completion rate in the secukinumab group was driven by a higher rate of lack of efficacy – 4.3%, compared to 0.6% for risankizumab – and a greater incidence of adverse events. Indeed, treatment-emergent adverse events were fourfold more common in the secukinumab arm, with a rate of 4.9%, versus 1.2% with risankizumab, according to Dr. Warren.
He reported receiving research grants from and serving as a consultant to the study sponsor, AbbVie, as well as roughly a dozen other pharmaceutical companies.
.
Risankizumab was better tolerated, with a significantly lower rate of treatment-emergent adverse events and a lower study dropout rate, Richard B. Warren, MBChB, PhD, reported at the virtual annual meeting of the American Academy of Dermatology.
In addition, the dosing schedule for risankizumab (Skyrizi) is more convenient, with maintenance dosing by subcutaneous injection once every 12 weeks, compared with monthly for secukinumab (Cosentyx), a biologic for psoriasis considered state-of-the-art not long ago, noted Dr. Warren, a dermatologist at the Salford (England) Royal NHS Foundation Trust and the Manchester NIHR Biomedical Research Center as well as professor of dermatology at the University of Manchester.
The phase 3 IMMERGE trial included 327 patients with moderate to severe psoriasis randomized to risankizumab or secukinumab for 52 weeks at their approved dosing. The trial, conducted mainly in the United States, Canada, and Europe, was open label, but evaluator blinded.
The coprimary endpoints were a 90% improvement from baseline in Psoriasis Area and Severity Index scores (PASI 90) at weeks 16 and 52. The week 52 PASI 90 response rates were 87% in the risankizumab group and 57% with secukinumab, for a highly significant absolute 30% difference. The week 16 result was a prespecified noninferiority analysis, and here again risankizumab met its mark, with a PASI 90 rate of 74%, statistically noninferior to the 66% rate with secukinumab, even though at that point patients had received only two doses of risankizumab, versus seven doses of secukinumab.
The PASI 100 response rate at 52 weeks, a key secondary endpoint, was 66% with risankizumab and 40% with secukinumab. Another secondary endpoint was achievement of a static Physician Global Assessment score of 0 or 1 – clear or almost clear – at week 52; the rates were 88% with risankizumab, 58% with secukinumab.
Ninety-two percent of participants randomized to risankizumab completed the full 52-week study, as did 82.8% of the secukinumab group. The nearly 10% absolute lower completion rate in the secukinumab group was driven by a higher rate of lack of efficacy – 4.3%, compared to 0.6% for risankizumab – and a greater incidence of adverse events. Indeed, treatment-emergent adverse events were fourfold more common in the secukinumab arm, with a rate of 4.9%, versus 1.2% with risankizumab, according to Dr. Warren.
He reported receiving research grants from and serving as a consultant to the study sponsor, AbbVie, as well as roughly a dozen other pharmaceutical companies.
.
Risankizumab was better tolerated, with a significantly lower rate of treatment-emergent adverse events and a lower study dropout rate, Richard B. Warren, MBChB, PhD, reported at the virtual annual meeting of the American Academy of Dermatology.
In addition, the dosing schedule for risankizumab (Skyrizi) is more convenient, with maintenance dosing by subcutaneous injection once every 12 weeks, compared with monthly for secukinumab (Cosentyx), a biologic for psoriasis considered state-of-the-art not long ago, noted Dr. Warren, a dermatologist at the Salford (England) Royal NHS Foundation Trust and the Manchester NIHR Biomedical Research Center as well as professor of dermatology at the University of Manchester.
The phase 3 IMMERGE trial included 327 patients with moderate to severe psoriasis randomized to risankizumab or secukinumab for 52 weeks at their approved dosing. The trial, conducted mainly in the United States, Canada, and Europe, was open label, but evaluator blinded.
The coprimary endpoints were a 90% improvement from baseline in Psoriasis Area and Severity Index scores (PASI 90) at weeks 16 and 52. The week 52 PASI 90 response rates were 87% in the risankizumab group and 57% with secukinumab, for a highly significant absolute 30% difference. The week 16 result was a prespecified noninferiority analysis, and here again risankizumab met its mark, with a PASI 90 rate of 74%, statistically noninferior to the 66% rate with secukinumab, even though at that point patients had received only two doses of risankizumab, versus seven doses of secukinumab.
The PASI 100 response rate at 52 weeks, a key secondary endpoint, was 66% with risankizumab and 40% with secukinumab. Another secondary endpoint was achievement of a static Physician Global Assessment score of 0 or 1 – clear or almost clear – at week 52; the rates were 88% with risankizumab, 58% with secukinumab.
Ninety-two percent of participants randomized to risankizumab completed the full 52-week study, as did 82.8% of the secukinumab group. The nearly 10% absolute lower completion rate in the secukinumab group was driven by a higher rate of lack of efficacy – 4.3%, compared to 0.6% for risankizumab – and a greater incidence of adverse events. Indeed, treatment-emergent adverse events were fourfold more common in the secukinumab arm, with a rate of 4.9%, versus 1.2% with risankizumab, according to Dr. Warren.
He reported receiving research grants from and serving as a consultant to the study sponsor, AbbVie, as well as roughly a dozen other pharmaceutical companies.
FROM AAD 20
EULAR gives pointers on intra-articular injection best practices
New EULAR recommendations for the intra-articular (IA) treatment of arthropathies aim to facilitate uniformity and quality of care for this mainstay of rheumatologic practice, according to a report on the new guidance that was presented at the annual European Congress of Rheumatology, held online this year due to COVID-19.
Until now there were no official recommendations on how best to use it in everyday practice. “This is the first time that there’s been a joint effort to develop evidence-based recommendations,” Jacqueline Usón, MD, PhD, associate professor medicine at Rey Juan Carlos University in Madrid, said in an interview. “Everything that we are saying is pretty logical, but it’s nice to see it put in recommendations based on evidence.”
IA therapy has been around for decades and is key for treating adults with a number of different conditions where synovitis, effusion, pain, or all three, are present, such as inflammatory arthritis and osteoarthritis, Dr. Usón observed during her presentation.
“Today, commonly used injectables are not only corticosteroids but also local anesthetics, hyaluronic acid, blood products, and maybe pharmaceuticals,” she said, adding that “there is a wide variation in the way intra-articular therapies are used and delivered to patients.” Health professionals also have very different views and habits depending on geographic locations and health care systems, she observed. Ironing out the variation was one of the main objectives of the recommendations.
As one of the two conveners of the EULAR task force behind the recommendations, Dr. Usón, herself a rheumatologist at University Hospital of Móstoles, pointed out that the task force brought together a range of specialties – rheumatologists, orthopedic surgeons, radiologists, nuclear medicine specialists, among others, as well as patients – to ensure that the best advice could be given.
The task force followed EULAR standard operating procedures for developing recommendations, with discussion groups, systematic literature reviews, and Delphi technique-based consensus all being employed. The literature search considered publications from 1946 up until 2019.
“We agreed on the need for more background information from health professionals and patients, so we developed two surveys: One for health professionals with 160 items, [for which] we obtained 186 responses from 26 countries; and the patient survey was made up of 44 items, translated into 10 different languages, and we obtained 200 responses,” she said.
The results of the systematic literature review and surveys were used to help form expert consensus, leading to 5 overarching principles and 11 recommendations that look at before, during, and after intra-articular therapy.
Five overarching principles
The first overarching principle recognizes the widespread use of IA therapies and that their use is specific to the disease that is being treated and “may not be interchangeable across indications,” Dr. Usón said. The second principle concerns improving patient-centered outcomes, which are “those that are relevant to the patient,” and include the benefits, harms, preferences, or implications for self-management.
“Contextual factors are important and contribute to the effect of IAT [intra-articular treatment],” she said, discussing the third principle. “These include effective communication, patient expectations, or settings [where the procedure takes place]. In addition, one should take into account that the route of delivery has in itself a placebo effect. We found that in different RCTs [randomized controlled trials], the pooled placebo effect of IA saline is moderate to large.”
The fourth principle looks at ensuring that patients and clinicians make an informed and shared decision, which is again highlighted by the first recommendation. The fifth, and last, overarching principle acknowledges that IA injections may be given by a range of health care professionals.
Advice for before, during, and after injection
Patients need to be “fully informed of the nature of the procedure, the injectable used, and potential effects – benefits and risks – [and] informed consent should be obtained and documented,” said Dr. Usón, outlining the first recommendation. “That seems common,” she said in the interview, “but when we did the survey, we realize that many patients didn’t [give consent], and the doctors didn’t even ask for it. This is why it’s a very general statement, and it’s our first recommendation. The agreement was 99%!”
The recommendations also look at the optimal settings for performing injections, such as providing a professional and private, well-lighted room, and having a resuscitation kit nearby in case patients faint. Accuracy is important, Dr. Usón said, and imaging, such as ultrasound, should be used where available to ensure accurate injection into the joint. This is an area where further research could be performed, she said, urging young rheumatologists and health professionals to consider this. “Intra-articular therapy is something that you learn and do, but you never really investigate in it,” she said.
One recommendation states that when intra-articular injections are being given to pregnant patients, the safety of injected compound must be considered, both for the mother and for the fetus. There is another recommendation on the need to perform IA injections under aseptic conditions, and another stating that patients should be offered local anesthetics, after explaining the pros and cons.
Special populations of patients are also considered, Dr. Usón said. For example, the guidance advises warning patients with diabetes of the risk of transient glycemia after IA glucocorticoids and the need to monitor their blood glucose levels carefully for a couple of days afterward.
As a rule, “IAT is not a contraindication to people with clotting or bleeding disorders, or taking antithrombotic medications,” she said, unless they are at a high risk of bleeding.
Importantly, the recommendations cover when IAT can be performed after joint replacement surgery (after at least 3 months), and the need to “avoid overuse of injected joints” while also avoiding complete immobilization for at least 24 hours afterward. The recommendations very generally cover re-injections, but not how long intervals between injections should be. When asked about interval duration after her presentation, Dr. Usón said that the usual advice is to give IA injections no more than 2-3 times a year, but it depends on the injectable.
“It wasn’t our intention to review the efficacy and the safety of the different injectables, nor to review the use of IAT in different types of joint diseases,” she said. “We do lack a lot of information, a lot of evidence in this, and I really would hope that new rheumatologists start looking into and start investigating in this topic,” she added.
Recommendations will increase awareness of good clinical practice
“IA injections are commonly administered in the rheumatology setting. This is because [IA injection] is often a useful treatment for acute flare of arthritis, particularly when it is limited to a few joints,” observed Ai Lyn Tan, MD, associate professor and honorary consultant rheumatologist at the Leeds (England) Institute of Rheumatic and Musculoskeletal Medicine.
IA injection “also relieves symptoms relatively quickly for patients; however, the response can be variable, and there are side effects associated with IA injections,” Dr. Tan added in an interview.
There is a lack of universally accepted recommendations, Dr. Tan observed, noting that while there might be some local guidelines on how to safely perform IA injections these were often not standardized and were subject to being continually updated to try to improve the experience for patients.
“It is therefore timely to learn about the new EULAR recommendations for IA injections. The advantage of this will be to increase awareness of good clinical practice for performing IA injections.”
Dr. Tan had no relevant conflicts of interest.
SOURCE: EULAR COVID-19 Recommendations. E-congress content available until Sept. 1, 2020.
New EULAR recommendations for the intra-articular (IA) treatment of arthropathies aim to facilitate uniformity and quality of care for this mainstay of rheumatologic practice, according to a report on the new guidance that was presented at the annual European Congress of Rheumatology, held online this year due to COVID-19.
Until now there were no official recommendations on how best to use it in everyday practice. “This is the first time that there’s been a joint effort to develop evidence-based recommendations,” Jacqueline Usón, MD, PhD, associate professor medicine at Rey Juan Carlos University in Madrid, said in an interview. “Everything that we are saying is pretty logical, but it’s nice to see it put in recommendations based on evidence.”
IA therapy has been around for decades and is key for treating adults with a number of different conditions where synovitis, effusion, pain, or all three, are present, such as inflammatory arthritis and osteoarthritis, Dr. Usón observed during her presentation.
“Today, commonly used injectables are not only corticosteroids but also local anesthetics, hyaluronic acid, blood products, and maybe pharmaceuticals,” she said, adding that “there is a wide variation in the way intra-articular therapies are used and delivered to patients.” Health professionals also have very different views and habits depending on geographic locations and health care systems, she observed. Ironing out the variation was one of the main objectives of the recommendations.
As one of the two conveners of the EULAR task force behind the recommendations, Dr. Usón, herself a rheumatologist at University Hospital of Móstoles, pointed out that the task force brought together a range of specialties – rheumatologists, orthopedic surgeons, radiologists, nuclear medicine specialists, among others, as well as patients – to ensure that the best advice could be given.
The task force followed EULAR standard operating procedures for developing recommendations, with discussion groups, systematic literature reviews, and Delphi technique-based consensus all being employed. The literature search considered publications from 1946 up until 2019.
“We agreed on the need for more background information from health professionals and patients, so we developed two surveys: One for health professionals with 160 items, [for which] we obtained 186 responses from 26 countries; and the patient survey was made up of 44 items, translated into 10 different languages, and we obtained 200 responses,” she said.
The results of the systematic literature review and surveys were used to help form expert consensus, leading to 5 overarching principles and 11 recommendations that look at before, during, and after intra-articular therapy.
Five overarching principles
The first overarching principle recognizes the widespread use of IA therapies and that their use is specific to the disease that is being treated and “may not be interchangeable across indications,” Dr. Usón said. The second principle concerns improving patient-centered outcomes, which are “those that are relevant to the patient,” and include the benefits, harms, preferences, or implications for self-management.
“Contextual factors are important and contribute to the effect of IAT [intra-articular treatment],” she said, discussing the third principle. “These include effective communication, patient expectations, or settings [where the procedure takes place]. In addition, one should take into account that the route of delivery has in itself a placebo effect. We found that in different RCTs [randomized controlled trials], the pooled placebo effect of IA saline is moderate to large.”
The fourth principle looks at ensuring that patients and clinicians make an informed and shared decision, which is again highlighted by the first recommendation. The fifth, and last, overarching principle acknowledges that IA injections may be given by a range of health care professionals.
Advice for before, during, and after injection
Patients need to be “fully informed of the nature of the procedure, the injectable used, and potential effects – benefits and risks – [and] informed consent should be obtained and documented,” said Dr. Usón, outlining the first recommendation. “That seems common,” she said in the interview, “but when we did the survey, we realize that many patients didn’t [give consent], and the doctors didn’t even ask for it. This is why it’s a very general statement, and it’s our first recommendation. The agreement was 99%!”
The recommendations also look at the optimal settings for performing injections, such as providing a professional and private, well-lighted room, and having a resuscitation kit nearby in case patients faint. Accuracy is important, Dr. Usón said, and imaging, such as ultrasound, should be used where available to ensure accurate injection into the joint. This is an area where further research could be performed, she said, urging young rheumatologists and health professionals to consider this. “Intra-articular therapy is something that you learn and do, but you never really investigate in it,” she said.
One recommendation states that when intra-articular injections are being given to pregnant patients, the safety of injected compound must be considered, both for the mother and for the fetus. There is another recommendation on the need to perform IA injections under aseptic conditions, and another stating that patients should be offered local anesthetics, after explaining the pros and cons.
Special populations of patients are also considered, Dr. Usón said. For example, the guidance advises warning patients with diabetes of the risk of transient glycemia after IA glucocorticoids and the need to monitor their blood glucose levels carefully for a couple of days afterward.
As a rule, “IAT is not a contraindication to people with clotting or bleeding disorders, or taking antithrombotic medications,” she said, unless they are at a high risk of bleeding.
Importantly, the recommendations cover when IAT can be performed after joint replacement surgery (after at least 3 months), and the need to “avoid overuse of injected joints” while also avoiding complete immobilization for at least 24 hours afterward. The recommendations very generally cover re-injections, but not how long intervals between injections should be. When asked about interval duration after her presentation, Dr. Usón said that the usual advice is to give IA injections no more than 2-3 times a year, but it depends on the injectable.
“It wasn’t our intention to review the efficacy and the safety of the different injectables, nor to review the use of IAT in different types of joint diseases,” she said. “We do lack a lot of information, a lot of evidence in this, and I really would hope that new rheumatologists start looking into and start investigating in this topic,” she added.
Recommendations will increase awareness of good clinical practice
“IA injections are commonly administered in the rheumatology setting. This is because [IA injection] is often a useful treatment for acute flare of arthritis, particularly when it is limited to a few joints,” observed Ai Lyn Tan, MD, associate professor and honorary consultant rheumatologist at the Leeds (England) Institute of Rheumatic and Musculoskeletal Medicine.
IA injection “also relieves symptoms relatively quickly for patients; however, the response can be variable, and there are side effects associated with IA injections,” Dr. Tan added in an interview.
There is a lack of universally accepted recommendations, Dr. Tan observed, noting that while there might be some local guidelines on how to safely perform IA injections these were often not standardized and were subject to being continually updated to try to improve the experience for patients.
“It is therefore timely to learn about the new EULAR recommendations for IA injections. The advantage of this will be to increase awareness of good clinical practice for performing IA injections.”
Dr. Tan had no relevant conflicts of interest.
SOURCE: EULAR COVID-19 Recommendations. E-congress content available until Sept. 1, 2020.
New EULAR recommendations for the intra-articular (IA) treatment of arthropathies aim to facilitate uniformity and quality of care for this mainstay of rheumatologic practice, according to a report on the new guidance that was presented at the annual European Congress of Rheumatology, held online this year due to COVID-19.
Until now there were no official recommendations on how best to use it in everyday practice. “This is the first time that there’s been a joint effort to develop evidence-based recommendations,” Jacqueline Usón, MD, PhD, associate professor medicine at Rey Juan Carlos University in Madrid, said in an interview. “Everything that we are saying is pretty logical, but it’s nice to see it put in recommendations based on evidence.”
IA therapy has been around for decades and is key for treating adults with a number of different conditions where synovitis, effusion, pain, or all three, are present, such as inflammatory arthritis and osteoarthritis, Dr. Usón observed during her presentation.
“Today, commonly used injectables are not only corticosteroids but also local anesthetics, hyaluronic acid, blood products, and maybe pharmaceuticals,” she said, adding that “there is a wide variation in the way intra-articular therapies are used and delivered to patients.” Health professionals also have very different views and habits depending on geographic locations and health care systems, she observed. Ironing out the variation was one of the main objectives of the recommendations.
As one of the two conveners of the EULAR task force behind the recommendations, Dr. Usón, herself a rheumatologist at University Hospital of Móstoles, pointed out that the task force brought together a range of specialties – rheumatologists, orthopedic surgeons, radiologists, nuclear medicine specialists, among others, as well as patients – to ensure that the best advice could be given.
The task force followed EULAR standard operating procedures for developing recommendations, with discussion groups, systematic literature reviews, and Delphi technique-based consensus all being employed. The literature search considered publications from 1946 up until 2019.
“We agreed on the need for more background information from health professionals and patients, so we developed two surveys: One for health professionals with 160 items, [for which] we obtained 186 responses from 26 countries; and the patient survey was made up of 44 items, translated into 10 different languages, and we obtained 200 responses,” she said.
The results of the systematic literature review and surveys were used to help form expert consensus, leading to 5 overarching principles and 11 recommendations that look at before, during, and after intra-articular therapy.
Five overarching principles
The first overarching principle recognizes the widespread use of IA therapies and that their use is specific to the disease that is being treated and “may not be interchangeable across indications,” Dr. Usón said. The second principle concerns improving patient-centered outcomes, which are “those that are relevant to the patient,” and include the benefits, harms, preferences, or implications for self-management.
“Contextual factors are important and contribute to the effect of IAT [intra-articular treatment],” she said, discussing the third principle. “These include effective communication, patient expectations, or settings [where the procedure takes place]. In addition, one should take into account that the route of delivery has in itself a placebo effect. We found that in different RCTs [randomized controlled trials], the pooled placebo effect of IA saline is moderate to large.”
The fourth principle looks at ensuring that patients and clinicians make an informed and shared decision, which is again highlighted by the first recommendation. The fifth, and last, overarching principle acknowledges that IA injections may be given by a range of health care professionals.
Advice for before, during, and after injection
Patients need to be “fully informed of the nature of the procedure, the injectable used, and potential effects – benefits and risks – [and] informed consent should be obtained and documented,” said Dr. Usón, outlining the first recommendation. “That seems common,” she said in the interview, “but when we did the survey, we realize that many patients didn’t [give consent], and the doctors didn’t even ask for it. This is why it’s a very general statement, and it’s our first recommendation. The agreement was 99%!”
The recommendations also look at the optimal settings for performing injections, such as providing a professional and private, well-lighted room, and having a resuscitation kit nearby in case patients faint. Accuracy is important, Dr. Usón said, and imaging, such as ultrasound, should be used where available to ensure accurate injection into the joint. This is an area where further research could be performed, she said, urging young rheumatologists and health professionals to consider this. “Intra-articular therapy is something that you learn and do, but you never really investigate in it,” she said.
One recommendation states that when intra-articular injections are being given to pregnant patients, the safety of injected compound must be considered, both for the mother and for the fetus. There is another recommendation on the need to perform IA injections under aseptic conditions, and another stating that patients should be offered local anesthetics, after explaining the pros and cons.
Special populations of patients are also considered, Dr. Usón said. For example, the guidance advises warning patients with diabetes of the risk of transient glycemia after IA glucocorticoids and the need to monitor their blood glucose levels carefully for a couple of days afterward.
As a rule, “IAT is not a contraindication to people with clotting or bleeding disorders, or taking antithrombotic medications,” she said, unless they are at a high risk of bleeding.
Importantly, the recommendations cover when IAT can be performed after joint replacement surgery (after at least 3 months), and the need to “avoid overuse of injected joints” while also avoiding complete immobilization for at least 24 hours afterward. The recommendations very generally cover re-injections, but not how long intervals between injections should be. When asked about interval duration after her presentation, Dr. Usón said that the usual advice is to give IA injections no more than 2-3 times a year, but it depends on the injectable.
“It wasn’t our intention to review the efficacy and the safety of the different injectables, nor to review the use of IAT in different types of joint diseases,” she said. “We do lack a lot of information, a lot of evidence in this, and I really would hope that new rheumatologists start looking into and start investigating in this topic,” she added.
Recommendations will increase awareness of good clinical practice
“IA injections are commonly administered in the rheumatology setting. This is because [IA injection] is often a useful treatment for acute flare of arthritis, particularly when it is limited to a few joints,” observed Ai Lyn Tan, MD, associate professor and honorary consultant rheumatologist at the Leeds (England) Institute of Rheumatic and Musculoskeletal Medicine.
IA injection “also relieves symptoms relatively quickly for patients; however, the response can be variable, and there are side effects associated with IA injections,” Dr. Tan added in an interview.
There is a lack of universally accepted recommendations, Dr. Tan observed, noting that while there might be some local guidelines on how to safely perform IA injections these were often not standardized and were subject to being continually updated to try to improve the experience for patients.
“It is therefore timely to learn about the new EULAR recommendations for IA injections. The advantage of this will be to increase awareness of good clinical practice for performing IA injections.”
Dr. Tan had no relevant conflicts of interest.
SOURCE: EULAR COVID-19 Recommendations. E-congress content available until Sept. 1, 2020.
FROM THE EULAR 2020 E-CONGRESS