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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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COVID-19: Convalescent plasma falls short in phase 2 trial
Convalescent plasma may not prevent progression to severe disease or reduce mortality risk in hospitalized patients with moderate COVID-19, based on a phase 2 trial involving more than 400 patients in India.
The PLACID trial offers real-world data with “high generalizability,” according to lead author Anup Agarwal, MD, of the Indian Council of Medical Research, New Delhi, and colleagues.
“Evidence suggests that convalescent plasma collected from survivors of COVID-19 contains receptor binding domain specific antibodies with potent antiviral activity,” the investigators wrote in the BMJ. “However, effective titers of antiviral neutralizing antibodies, optimal timing for convalescent plasma treatment, optimal timing for plasma donation, and the severity class of patients who are likely to benefit from convalescent plasma remain unclear.”
According to Dr. Agarwal and colleagues, case series and observational studies have suggested that convalescent plasma may reduce viral load, hospital stay, and mortality, but randomized controlled trials to date have ended prematurely because of issues with enrollment and design, making PLACID the first randomized controlled trial of its kind to reach completion.
The open-label, multicenter study involved 464 hospitalized adults who tested positive for SARS-CoV-2 via reverse transcription polymerase chain reaction (RT-PCR). Enrollment also required a respiratory rate of more than 24 breaths/min with an oxygen saturation (SpO2) of 93% or less on room air, or a partial pressure of oxygen in arterial blood/fraction of inspired oxygen (PaO2 /FiO2 ) ratio between 200 and 300 mm Hg.
Patients were randomly assigned in a 1:1 ratio to receive either best standard of care (control), or best standard of care plus convalescent plasma, which was given in two doses of 200 mL, 24 hours apart. Patients were assessed via clinical examination, chest imaging, and serial laboratory testing, the latter of which included neutralizing antibody titers on days 0, 3, and 7.
The primary outcome was a 28-day composite of progression to severe disease (PaO2/FiO2 ratio < 100 mm Hg) and all-cause mortality. An array of secondary outcomes were also reported, including symptom resolution, total duration of respiratory support, change in oxygen requirement, and others.
In the convalescent plasma group, 19% of patients progressed to severe disease or died within 28 days, compared with 18% of those in the control group (risk ratio, 1.04; 95% confidence interval, 0.71-1.54), suggesting no statistically significant benefit from the intervention. This lack of benefit was also found in a subgroup analysis of patients with detectable titers of antibodies to SARS-CoV-2, and when progression to severe disease and all-cause mortality were analyzed independently across all patients.
Still, at day 7, patients treated with convalescent plasma were significantly more likely to have resolution of fatigue (RR, 1.21; 95% CI, 1.02-1.42) and shortness of breath (RR, 1.16; 95% CI, 1.02-1.32). And at the same time point, patients treated with convalescent plasma were 20% more likely to test negative for SARS-CoV-2 RNA (RR, 1.2; 95% CI, 1.04-1.5).
In an accompanying editorial, Elizabeth B. Pathak, PhD, of the Women’s Institute for Independent Social Enquiry, Olney, Md., suggested that the reported symptom improvements need to be viewed with skepticism.
“These results should be interpreted with caution, because the trial was not blinded, so knowledge of treatment status could have influenced the reporting of subjective symptoms by patients who survived to day 7,” Dr. Pathak wrote.
Dr. Pathak noted that convalescent plasma did appear to have an antiviral effect, based on the higher rate of negative RNA test results at day 7. She hypothesized that the lack of major corresponding clinical benefit could be explained by detrimental thrombotic processes.
“The net effect of plasma is prothrombotic,” Dr. Pathak wrote, which should raise safety concerns, since “COVID-19 is a life-threatening thrombotic disorder.”
According to Dr. Pathak, large-scale datasets may be giving a false sense of security. She cited a recent safety analysis of 20,000 U.S. patients who received convalescent plasma, in which the investigators excluded 88.2% of cardiac events and 66.3% of thrombotic events, as these were deemed unrelated to transfusion; but this decision was made by the treating physician, without independent review or a defined protocol.
Michael J. Joyner, MD, of the Mayo Clinic in Rochester, Minn., was the lead author of the above safety study, and is leading the Food and Drug Administration expanded access program for convalescent plasma in patients with COVID-19. He suggested that the study by Dr. Agarwal and colleagues was admirable, but flaws in the treatment protocol cast doubt upon the efficacy findings.
“It is very impressive that these investigators performed a large trial of convalescent plasma in the midst of a pandemic,” Dr. Joyner said. “Unfortunately it is unclear how generalizable the findings are because many of the units of plasma had either very low or no antibody titers and because the plasma was given late in the course of the disease. It has been known since at least the 1930s that antibody therapy works best when enough product is given either prophylactically or early in the course of disease.”
Dr. Joyner had a more positive interpretation of the reported symptom improvements.
“It is also interesting to note that while there was no mortality benefit, that – even with the limitations of the study – there was some evidence of improved patient physiology at 7 days,” he said. “So, at one level, [this is] a negative study, but at least [there are] some hints of efficacy given the suboptimal use case in the patients studied.”
The study was funded by the Indian Council of Medical Research, which employs several of the authors and PLACID Trial Collaborators. Dr. Pathak and Dr. Joyner reported no conflicts of interest.
SOURCE: Agarwal A et al. BMJ. 2020 Oct 23. doi: 10.1136/bmj.m3939 .
Convalescent plasma may not prevent progression to severe disease or reduce mortality risk in hospitalized patients with moderate COVID-19, based on a phase 2 trial involving more than 400 patients in India.
The PLACID trial offers real-world data with “high generalizability,” according to lead author Anup Agarwal, MD, of the Indian Council of Medical Research, New Delhi, and colleagues.
“Evidence suggests that convalescent plasma collected from survivors of COVID-19 contains receptor binding domain specific antibodies with potent antiviral activity,” the investigators wrote in the BMJ. “However, effective titers of antiviral neutralizing antibodies, optimal timing for convalescent plasma treatment, optimal timing for plasma donation, and the severity class of patients who are likely to benefit from convalescent plasma remain unclear.”
According to Dr. Agarwal and colleagues, case series and observational studies have suggested that convalescent plasma may reduce viral load, hospital stay, and mortality, but randomized controlled trials to date have ended prematurely because of issues with enrollment and design, making PLACID the first randomized controlled trial of its kind to reach completion.
The open-label, multicenter study involved 464 hospitalized adults who tested positive for SARS-CoV-2 via reverse transcription polymerase chain reaction (RT-PCR). Enrollment also required a respiratory rate of more than 24 breaths/min with an oxygen saturation (SpO2) of 93% or less on room air, or a partial pressure of oxygen in arterial blood/fraction of inspired oxygen (PaO2 /FiO2 ) ratio between 200 and 300 mm Hg.
Patients were randomly assigned in a 1:1 ratio to receive either best standard of care (control), or best standard of care plus convalescent plasma, which was given in two doses of 200 mL, 24 hours apart. Patients were assessed via clinical examination, chest imaging, and serial laboratory testing, the latter of which included neutralizing antibody titers on days 0, 3, and 7.
The primary outcome was a 28-day composite of progression to severe disease (PaO2/FiO2 ratio < 100 mm Hg) and all-cause mortality. An array of secondary outcomes were also reported, including symptom resolution, total duration of respiratory support, change in oxygen requirement, and others.
In the convalescent plasma group, 19% of patients progressed to severe disease or died within 28 days, compared with 18% of those in the control group (risk ratio, 1.04; 95% confidence interval, 0.71-1.54), suggesting no statistically significant benefit from the intervention. This lack of benefit was also found in a subgroup analysis of patients with detectable titers of antibodies to SARS-CoV-2, and when progression to severe disease and all-cause mortality were analyzed independently across all patients.
Still, at day 7, patients treated with convalescent plasma were significantly more likely to have resolution of fatigue (RR, 1.21; 95% CI, 1.02-1.42) and shortness of breath (RR, 1.16; 95% CI, 1.02-1.32). And at the same time point, patients treated with convalescent plasma were 20% more likely to test negative for SARS-CoV-2 RNA (RR, 1.2; 95% CI, 1.04-1.5).
In an accompanying editorial, Elizabeth B. Pathak, PhD, of the Women’s Institute for Independent Social Enquiry, Olney, Md., suggested that the reported symptom improvements need to be viewed with skepticism.
“These results should be interpreted with caution, because the trial was not blinded, so knowledge of treatment status could have influenced the reporting of subjective symptoms by patients who survived to day 7,” Dr. Pathak wrote.
Dr. Pathak noted that convalescent plasma did appear to have an antiviral effect, based on the higher rate of negative RNA test results at day 7. She hypothesized that the lack of major corresponding clinical benefit could be explained by detrimental thrombotic processes.
“The net effect of plasma is prothrombotic,” Dr. Pathak wrote, which should raise safety concerns, since “COVID-19 is a life-threatening thrombotic disorder.”
According to Dr. Pathak, large-scale datasets may be giving a false sense of security. She cited a recent safety analysis of 20,000 U.S. patients who received convalescent plasma, in which the investigators excluded 88.2% of cardiac events and 66.3% of thrombotic events, as these were deemed unrelated to transfusion; but this decision was made by the treating physician, without independent review or a defined protocol.
Michael J. Joyner, MD, of the Mayo Clinic in Rochester, Minn., was the lead author of the above safety study, and is leading the Food and Drug Administration expanded access program for convalescent plasma in patients with COVID-19. He suggested that the study by Dr. Agarwal and colleagues was admirable, but flaws in the treatment protocol cast doubt upon the efficacy findings.
“It is very impressive that these investigators performed a large trial of convalescent plasma in the midst of a pandemic,” Dr. Joyner said. “Unfortunately it is unclear how generalizable the findings are because many of the units of plasma had either very low or no antibody titers and because the plasma was given late in the course of the disease. It has been known since at least the 1930s that antibody therapy works best when enough product is given either prophylactically or early in the course of disease.”
Dr. Joyner had a more positive interpretation of the reported symptom improvements.
“It is also interesting to note that while there was no mortality benefit, that – even with the limitations of the study – there was some evidence of improved patient physiology at 7 days,” he said. “So, at one level, [this is] a negative study, but at least [there are] some hints of efficacy given the suboptimal use case in the patients studied.”
The study was funded by the Indian Council of Medical Research, which employs several of the authors and PLACID Trial Collaborators. Dr. Pathak and Dr. Joyner reported no conflicts of interest.
SOURCE: Agarwal A et al. BMJ. 2020 Oct 23. doi: 10.1136/bmj.m3939 .
Convalescent plasma may not prevent progression to severe disease or reduce mortality risk in hospitalized patients with moderate COVID-19, based on a phase 2 trial involving more than 400 patients in India.
The PLACID trial offers real-world data with “high generalizability,” according to lead author Anup Agarwal, MD, of the Indian Council of Medical Research, New Delhi, and colleagues.
“Evidence suggests that convalescent plasma collected from survivors of COVID-19 contains receptor binding domain specific antibodies with potent antiviral activity,” the investigators wrote in the BMJ. “However, effective titers of antiviral neutralizing antibodies, optimal timing for convalescent plasma treatment, optimal timing for plasma donation, and the severity class of patients who are likely to benefit from convalescent plasma remain unclear.”
According to Dr. Agarwal and colleagues, case series and observational studies have suggested that convalescent plasma may reduce viral load, hospital stay, and mortality, but randomized controlled trials to date have ended prematurely because of issues with enrollment and design, making PLACID the first randomized controlled trial of its kind to reach completion.
The open-label, multicenter study involved 464 hospitalized adults who tested positive for SARS-CoV-2 via reverse transcription polymerase chain reaction (RT-PCR). Enrollment also required a respiratory rate of more than 24 breaths/min with an oxygen saturation (SpO2) of 93% or less on room air, or a partial pressure of oxygen in arterial blood/fraction of inspired oxygen (PaO2 /FiO2 ) ratio between 200 and 300 mm Hg.
Patients were randomly assigned in a 1:1 ratio to receive either best standard of care (control), or best standard of care plus convalescent plasma, which was given in two doses of 200 mL, 24 hours apart. Patients were assessed via clinical examination, chest imaging, and serial laboratory testing, the latter of which included neutralizing antibody titers on days 0, 3, and 7.
The primary outcome was a 28-day composite of progression to severe disease (PaO2/FiO2 ratio < 100 mm Hg) and all-cause mortality. An array of secondary outcomes were also reported, including symptom resolution, total duration of respiratory support, change in oxygen requirement, and others.
In the convalescent plasma group, 19% of patients progressed to severe disease or died within 28 days, compared with 18% of those in the control group (risk ratio, 1.04; 95% confidence interval, 0.71-1.54), suggesting no statistically significant benefit from the intervention. This lack of benefit was also found in a subgroup analysis of patients with detectable titers of antibodies to SARS-CoV-2, and when progression to severe disease and all-cause mortality were analyzed independently across all patients.
Still, at day 7, patients treated with convalescent plasma were significantly more likely to have resolution of fatigue (RR, 1.21; 95% CI, 1.02-1.42) and shortness of breath (RR, 1.16; 95% CI, 1.02-1.32). And at the same time point, patients treated with convalescent plasma were 20% more likely to test negative for SARS-CoV-2 RNA (RR, 1.2; 95% CI, 1.04-1.5).
In an accompanying editorial, Elizabeth B. Pathak, PhD, of the Women’s Institute for Independent Social Enquiry, Olney, Md., suggested that the reported symptom improvements need to be viewed with skepticism.
“These results should be interpreted with caution, because the trial was not blinded, so knowledge of treatment status could have influenced the reporting of subjective symptoms by patients who survived to day 7,” Dr. Pathak wrote.
Dr. Pathak noted that convalescent plasma did appear to have an antiviral effect, based on the higher rate of negative RNA test results at day 7. She hypothesized that the lack of major corresponding clinical benefit could be explained by detrimental thrombotic processes.
“The net effect of plasma is prothrombotic,” Dr. Pathak wrote, which should raise safety concerns, since “COVID-19 is a life-threatening thrombotic disorder.”
According to Dr. Pathak, large-scale datasets may be giving a false sense of security. She cited a recent safety analysis of 20,000 U.S. patients who received convalescent plasma, in which the investigators excluded 88.2% of cardiac events and 66.3% of thrombotic events, as these were deemed unrelated to transfusion; but this decision was made by the treating physician, without independent review or a defined protocol.
Michael J. Joyner, MD, of the Mayo Clinic in Rochester, Minn., was the lead author of the above safety study, and is leading the Food and Drug Administration expanded access program for convalescent plasma in patients with COVID-19. He suggested that the study by Dr. Agarwal and colleagues was admirable, but flaws in the treatment protocol cast doubt upon the efficacy findings.
“It is very impressive that these investigators performed a large trial of convalescent plasma in the midst of a pandemic,” Dr. Joyner said. “Unfortunately it is unclear how generalizable the findings are because many of the units of plasma had either very low or no antibody titers and because the plasma was given late in the course of the disease. It has been known since at least the 1930s that antibody therapy works best when enough product is given either prophylactically or early in the course of disease.”
Dr. Joyner had a more positive interpretation of the reported symptom improvements.
“It is also interesting to note that while there was no mortality benefit, that – even with the limitations of the study – there was some evidence of improved patient physiology at 7 days,” he said. “So, at one level, [this is] a negative study, but at least [there are] some hints of efficacy given the suboptimal use case in the patients studied.”
The study was funded by the Indian Council of Medical Research, which employs several of the authors and PLACID Trial Collaborators. Dr. Pathak and Dr. Joyner reported no conflicts of interest.
SOURCE: Agarwal A et al. BMJ. 2020 Oct 23. doi: 10.1136/bmj.m3939 .
FROM BMJ
FDA approves remdesivir, first treatment for COVID-19
making it the first and only approved treatment for COVID-19, according to a release from drug manufacturer Gilead Sciences.
The FDA’s initial Emergency Use Authorization (EUA) of the antiviral, issued in May, allowed the drug to be used only for patients with severe COVID-19, specifically, COVID-19 patients with low blood oxygen levels or who needed oxygen therapy or mechanical ventilation.
An August EUA expanded treatment to include all adult and pediatric hospitalized COVID-19 patients, regardless of the severity of their disease. The FDA also issued a new EUA for remdesivir Oct. 22 allowing treatment of hospitalized pediatric patients younger than 12 weighing at least 3.5 kg.
Today’s approval is based on three randomized controlled trials, according to Gilead.
Final trial results from one of them, the National Institute of Allergy and Infectious Disease–funded ACTT-1 trial, published earlier in October, showed that hospitalized patients with COVID-19 who received remdesivir had a shorter median recovery time than those who received a placebo – 10 days versus 15 days.
This difference and some related secondary endpoints were statistically significant in the randomized trial, but there was not a statistically significant difference in mortality between the treatment and placebo groups.
The other two trials used for the approval, the SIMPLE trials, were open-label phase 3 trials conducted in countries with a high prevalence of COVID-19 infections, according to Gilead.
The SIMPLE-Severe trial was a randomized, multicenter study that evaluated the efficacy and safety of 5-day and 10-day dosing plus standard of care in 397 hospitalized adult patients with severe COVID-19. The primary endpoint was clinical status on day 14 assessed on a 7-point ordinal scale, according to Gilead.
The trial found that a 5-day or a 10-day treatment course of Veklury achieved similar clinical outcomes to the ACTT-1 trial (odds ratio, 0.75; 95% confidence interval, 0.51-1.12).
The SIMPLE-Moderate trial was a randomized, controlled, multicenter study that evaluated the efficacy and safety of 5-day and 10-day dosing durations of Veklury plus standard of care, compared with standard of care alone in 600 hospitalized adult patients with moderate COVID-19, Gilead stated in its release.
The primary endpoint was clinical status on day 11 assessed on a 7-point ordinal scale.
The results showed statistically improved clinical outcomes with a 5-day treatment course of Veklury, compared with standard of care (OR, 1.65; 95% CI, 1.0-2.48; P = .017), according to Gilead.
This article first appeared on Medscape.com.
making it the first and only approved treatment for COVID-19, according to a release from drug manufacturer Gilead Sciences.
The FDA’s initial Emergency Use Authorization (EUA) of the antiviral, issued in May, allowed the drug to be used only for patients with severe COVID-19, specifically, COVID-19 patients with low blood oxygen levels or who needed oxygen therapy or mechanical ventilation.
An August EUA expanded treatment to include all adult and pediatric hospitalized COVID-19 patients, regardless of the severity of their disease. The FDA also issued a new EUA for remdesivir Oct. 22 allowing treatment of hospitalized pediatric patients younger than 12 weighing at least 3.5 kg.
Today’s approval is based on three randomized controlled trials, according to Gilead.
Final trial results from one of them, the National Institute of Allergy and Infectious Disease–funded ACTT-1 trial, published earlier in October, showed that hospitalized patients with COVID-19 who received remdesivir had a shorter median recovery time than those who received a placebo – 10 days versus 15 days.
This difference and some related secondary endpoints were statistically significant in the randomized trial, but there was not a statistically significant difference in mortality between the treatment and placebo groups.
The other two trials used for the approval, the SIMPLE trials, were open-label phase 3 trials conducted in countries with a high prevalence of COVID-19 infections, according to Gilead.
The SIMPLE-Severe trial was a randomized, multicenter study that evaluated the efficacy and safety of 5-day and 10-day dosing plus standard of care in 397 hospitalized adult patients with severe COVID-19. The primary endpoint was clinical status on day 14 assessed on a 7-point ordinal scale, according to Gilead.
The trial found that a 5-day or a 10-day treatment course of Veklury achieved similar clinical outcomes to the ACTT-1 trial (odds ratio, 0.75; 95% confidence interval, 0.51-1.12).
The SIMPLE-Moderate trial was a randomized, controlled, multicenter study that evaluated the efficacy and safety of 5-day and 10-day dosing durations of Veklury plus standard of care, compared with standard of care alone in 600 hospitalized adult patients with moderate COVID-19, Gilead stated in its release.
The primary endpoint was clinical status on day 11 assessed on a 7-point ordinal scale.
The results showed statistically improved clinical outcomes with a 5-day treatment course of Veklury, compared with standard of care (OR, 1.65; 95% CI, 1.0-2.48; P = .017), according to Gilead.
This article first appeared on Medscape.com.
making it the first and only approved treatment for COVID-19, according to a release from drug manufacturer Gilead Sciences.
The FDA’s initial Emergency Use Authorization (EUA) of the antiviral, issued in May, allowed the drug to be used only for patients with severe COVID-19, specifically, COVID-19 patients with low blood oxygen levels or who needed oxygen therapy or mechanical ventilation.
An August EUA expanded treatment to include all adult and pediatric hospitalized COVID-19 patients, regardless of the severity of their disease. The FDA also issued a new EUA for remdesivir Oct. 22 allowing treatment of hospitalized pediatric patients younger than 12 weighing at least 3.5 kg.
Today’s approval is based on three randomized controlled trials, according to Gilead.
Final trial results from one of them, the National Institute of Allergy and Infectious Disease–funded ACTT-1 trial, published earlier in October, showed that hospitalized patients with COVID-19 who received remdesivir had a shorter median recovery time than those who received a placebo – 10 days versus 15 days.
This difference and some related secondary endpoints were statistically significant in the randomized trial, but there was not a statistically significant difference in mortality between the treatment and placebo groups.
The other two trials used for the approval, the SIMPLE trials, were open-label phase 3 trials conducted in countries with a high prevalence of COVID-19 infections, according to Gilead.
The SIMPLE-Severe trial was a randomized, multicenter study that evaluated the efficacy and safety of 5-day and 10-day dosing plus standard of care in 397 hospitalized adult patients with severe COVID-19. The primary endpoint was clinical status on day 14 assessed on a 7-point ordinal scale, according to Gilead.
The trial found that a 5-day or a 10-day treatment course of Veklury achieved similar clinical outcomes to the ACTT-1 trial (odds ratio, 0.75; 95% confidence interval, 0.51-1.12).
The SIMPLE-Moderate trial was a randomized, controlled, multicenter study that evaluated the efficacy and safety of 5-day and 10-day dosing durations of Veklury plus standard of care, compared with standard of care alone in 600 hospitalized adult patients with moderate COVID-19, Gilead stated in its release.
The primary endpoint was clinical status on day 11 assessed on a 7-point ordinal scale.
The results showed statistically improved clinical outcomes with a 5-day treatment course of Veklury, compared with standard of care (OR, 1.65; 95% CI, 1.0-2.48; P = .017), according to Gilead.
This article first appeared on Medscape.com.
Rinse and repeat? Mouthwash might mitigate COVID-19 spread
Listerine Antiseptic led the list of most effective mouthwashes for inactivating the coronavirus. Interestingly, a 1% nasal rinse solution of Johnson’s Baby Shampoo also worked, eliminating up to 99.9% of the viral load in the in vitro experiments.
In contrast, use of a neti pot nasal solution yielded no decrease in virus levels.
The study was published in the Journal of Medical Virology.
Because the mouthwash and hydrogen peroxide oral rinses in the study are widely available and easy to use, “I would recommend the use of the rinses on top of wearing mask and social distancing. This could add a layer of protection for yourself and others,” lead study author Craig Meyers, PhD, professor of microbiology and immunology and obstetrics and gynecology, Penn State College of Medicine in Hershey, Pennsylvania, told Medscape Medical News.
Meyers and colleagues found that efficacy aligned with duration of time the cell cultures were exposed to each mouthwash or rinse product. Although it varied, the products required at least 30 seconds to kill most of the virus. Waiting 1 or 2 minutes tended to fortify results.
“This study adds to and further confirms the recently published evidence from virologists in Germany that mouthwashes can inactivate the virus that causes COVID-19 in a test tube,” Valerie O’Donnell, PhD, co-director of the Systems Immunity Research Institute of Cardiff University, Cardiff, Wales, said when asked to comment on the study.
“While this is great to see, what is still lacking is in vivo evidence, since we know the virus will be continually shed in the mouth,” O’Donnell said. “So, the question now becomes, by how much could mouthwashes reduce viral load in the oropharynx of infected people, and if so, then for how long?”
Meyers noted that studies of people positive for COVID-19 using each product would be informative. It remains unknown, for example, if swishing, gargling, and/or spitting out mouthwash would add or decrease the efficacy demonstrated in the lab.
The investigators used the human coronavirus HCoV‐229e as a surrogate for SARS-CoV-2. They noted HCoV-229e is analogous, and SARS-CoV-2 would have been more expensive, less available, and would have required biosafety level 3 laboratory conditions.
Listerine Antiseptic leads the way
“Surprisingly, we found that several of these common products had strong virucidal properties, inactivating from 2 log10 [or 99%] to greater than 4 log10 [or 99.99%] of infectious human coronavirus,” the researchers note.
The researchers added a small amount of organic material (extra protein) to each product to more closely mimic physiologic conditions in the nasopharynx.
Listerine Antiseptic “historically has claimed numerous antimicrobial properties,” the researchers note. Although the label currently only claims to kill germs that cause bad breath, “our tests show that it is highly effective at inactivating human coronavirus in solution. Even at the lowest contact time of 30 seconds, it inactivated greater than 99.99% of human coronavirus.”
Interestingly, the mouthwashes that contained the same active ingredients as Listerine Antiseptic — Listerine Ultra, Equate Antiseptic, and CVS Antiseptic Mouth Wash — were less efficacious. Meyers said the reason remains unclear, but he and colleagues found the same result when they repeated the comparisons.
Timing of the essence?
Meyers and colleagues also tested a nasal rinse solution of 1% baby shampoo because it is sometimes used to treat people with chronic rhinosinusitis. They found 30 seconds led to < 90% to < 99.99% effectiveness, but that, by 2 minutes, efficacy climbed to > 99.9% to > 99.99%.
“Thirty seconds for some products just was not enough time for the efficacy to be observed,” Meyers said. “Whereas, after a minute or two the active ingredient had enough time to work. Thirty seconds may be at the border to see full efficacy.” More research is needed to confirm the timing and determine which active ingredients are driving the findings.
A future trial could test the efficacy of mouthwash products to reduce the viral load in people with COVID-19. “If we are able to get funding to continue, I would like to see a small clinical trial as the next step,” Meyers said.
Meyers and O’Donnell disclosed no relevant financial relationships.
This article first appeared on Medscape.com.
Listerine Antiseptic led the list of most effective mouthwashes for inactivating the coronavirus. Interestingly, a 1% nasal rinse solution of Johnson’s Baby Shampoo also worked, eliminating up to 99.9% of the viral load in the in vitro experiments.
In contrast, use of a neti pot nasal solution yielded no decrease in virus levels.
The study was published in the Journal of Medical Virology.
Because the mouthwash and hydrogen peroxide oral rinses in the study are widely available and easy to use, “I would recommend the use of the rinses on top of wearing mask and social distancing. This could add a layer of protection for yourself and others,” lead study author Craig Meyers, PhD, professor of microbiology and immunology and obstetrics and gynecology, Penn State College of Medicine in Hershey, Pennsylvania, told Medscape Medical News.
Meyers and colleagues found that efficacy aligned with duration of time the cell cultures were exposed to each mouthwash or rinse product. Although it varied, the products required at least 30 seconds to kill most of the virus. Waiting 1 or 2 minutes tended to fortify results.
“This study adds to and further confirms the recently published evidence from virologists in Germany that mouthwashes can inactivate the virus that causes COVID-19 in a test tube,” Valerie O’Donnell, PhD, co-director of the Systems Immunity Research Institute of Cardiff University, Cardiff, Wales, said when asked to comment on the study.
“While this is great to see, what is still lacking is in vivo evidence, since we know the virus will be continually shed in the mouth,” O’Donnell said. “So, the question now becomes, by how much could mouthwashes reduce viral load in the oropharynx of infected people, and if so, then for how long?”
Meyers noted that studies of people positive for COVID-19 using each product would be informative. It remains unknown, for example, if swishing, gargling, and/or spitting out mouthwash would add or decrease the efficacy demonstrated in the lab.
The investigators used the human coronavirus HCoV‐229e as a surrogate for SARS-CoV-2. They noted HCoV-229e is analogous, and SARS-CoV-2 would have been more expensive, less available, and would have required biosafety level 3 laboratory conditions.
Listerine Antiseptic leads the way
“Surprisingly, we found that several of these common products had strong virucidal properties, inactivating from 2 log10 [or 99%] to greater than 4 log10 [or 99.99%] of infectious human coronavirus,” the researchers note.
The researchers added a small amount of organic material (extra protein) to each product to more closely mimic physiologic conditions in the nasopharynx.
Listerine Antiseptic “historically has claimed numerous antimicrobial properties,” the researchers note. Although the label currently only claims to kill germs that cause bad breath, “our tests show that it is highly effective at inactivating human coronavirus in solution. Even at the lowest contact time of 30 seconds, it inactivated greater than 99.99% of human coronavirus.”
Interestingly, the mouthwashes that contained the same active ingredients as Listerine Antiseptic — Listerine Ultra, Equate Antiseptic, and CVS Antiseptic Mouth Wash — were less efficacious. Meyers said the reason remains unclear, but he and colleagues found the same result when they repeated the comparisons.
Timing of the essence?
Meyers and colleagues also tested a nasal rinse solution of 1% baby shampoo because it is sometimes used to treat people with chronic rhinosinusitis. They found 30 seconds led to < 90% to < 99.99% effectiveness, but that, by 2 minutes, efficacy climbed to > 99.9% to > 99.99%.
“Thirty seconds for some products just was not enough time for the efficacy to be observed,” Meyers said. “Whereas, after a minute or two the active ingredient had enough time to work. Thirty seconds may be at the border to see full efficacy.” More research is needed to confirm the timing and determine which active ingredients are driving the findings.
A future trial could test the efficacy of mouthwash products to reduce the viral load in people with COVID-19. “If we are able to get funding to continue, I would like to see a small clinical trial as the next step,” Meyers said.
Meyers and O’Donnell disclosed no relevant financial relationships.
This article first appeared on Medscape.com.
Listerine Antiseptic led the list of most effective mouthwashes for inactivating the coronavirus. Interestingly, a 1% nasal rinse solution of Johnson’s Baby Shampoo also worked, eliminating up to 99.9% of the viral load in the in vitro experiments.
In contrast, use of a neti pot nasal solution yielded no decrease in virus levels.
The study was published in the Journal of Medical Virology.
Because the mouthwash and hydrogen peroxide oral rinses in the study are widely available and easy to use, “I would recommend the use of the rinses on top of wearing mask and social distancing. This could add a layer of protection for yourself and others,” lead study author Craig Meyers, PhD, professor of microbiology and immunology and obstetrics and gynecology, Penn State College of Medicine in Hershey, Pennsylvania, told Medscape Medical News.
Meyers and colleagues found that efficacy aligned with duration of time the cell cultures were exposed to each mouthwash or rinse product. Although it varied, the products required at least 30 seconds to kill most of the virus. Waiting 1 or 2 minutes tended to fortify results.
“This study adds to and further confirms the recently published evidence from virologists in Germany that mouthwashes can inactivate the virus that causes COVID-19 in a test tube,” Valerie O’Donnell, PhD, co-director of the Systems Immunity Research Institute of Cardiff University, Cardiff, Wales, said when asked to comment on the study.
“While this is great to see, what is still lacking is in vivo evidence, since we know the virus will be continually shed in the mouth,” O’Donnell said. “So, the question now becomes, by how much could mouthwashes reduce viral load in the oropharynx of infected people, and if so, then for how long?”
Meyers noted that studies of people positive for COVID-19 using each product would be informative. It remains unknown, for example, if swishing, gargling, and/or spitting out mouthwash would add or decrease the efficacy demonstrated in the lab.
The investigators used the human coronavirus HCoV‐229e as a surrogate for SARS-CoV-2. They noted HCoV-229e is analogous, and SARS-CoV-2 would have been more expensive, less available, and would have required biosafety level 3 laboratory conditions.
Listerine Antiseptic leads the way
“Surprisingly, we found that several of these common products had strong virucidal properties, inactivating from 2 log10 [or 99%] to greater than 4 log10 [or 99.99%] of infectious human coronavirus,” the researchers note.
The researchers added a small amount of organic material (extra protein) to each product to more closely mimic physiologic conditions in the nasopharynx.
Listerine Antiseptic “historically has claimed numerous antimicrobial properties,” the researchers note. Although the label currently only claims to kill germs that cause bad breath, “our tests show that it is highly effective at inactivating human coronavirus in solution. Even at the lowest contact time of 30 seconds, it inactivated greater than 99.99% of human coronavirus.”
Interestingly, the mouthwashes that contained the same active ingredients as Listerine Antiseptic — Listerine Ultra, Equate Antiseptic, and CVS Antiseptic Mouth Wash — were less efficacious. Meyers said the reason remains unclear, but he and colleagues found the same result when they repeated the comparisons.
Timing of the essence?
Meyers and colleagues also tested a nasal rinse solution of 1% baby shampoo because it is sometimes used to treat people with chronic rhinosinusitis. They found 30 seconds led to < 90% to < 99.99% effectiveness, but that, by 2 minutes, efficacy climbed to > 99.9% to > 99.99%.
“Thirty seconds for some products just was not enough time for the efficacy to be observed,” Meyers said. “Whereas, after a minute or two the active ingredient had enough time to work. Thirty seconds may be at the border to see full efficacy.” More research is needed to confirm the timing and determine which active ingredients are driving the findings.
A future trial could test the efficacy of mouthwash products to reduce the viral load in people with COVID-19. “If we are able to get funding to continue, I would like to see a small clinical trial as the next step,” Meyers said.
Meyers and O’Donnell disclosed no relevant financial relationships.
This article first appeared on Medscape.com.
Patients can read your clinical notes starting Nov. 2
Starting Nov. 2, all patients in the United States will have immediate access to clinical notes and thus will be able to read their doctors’ writings, as well as test results and reports from pathology and imaging.
The 21st Century Cures Act mandates that patients have fast, electronic access to the following types of notes: consultations, discharge summaries, history, physical examination findings, imaging narratives, laboratory and pathology report narratives, and procedure and progress notes.
But this federal mandate, called “open notes” by many, is potentially confusing and frightening for patients, say some physicians. Others worry that the change will increase workload as clinicians tailor notes for patients and answer related questions.
The law means that inpatient and outpatient notes will be released immediately and that patients will have immediate access to testing and imaging results, including results from sexually transmitted disease tests, Pap tests, cancer biopsies, CT and PET scans, fetal ultrasounds, pneumonia cultures, and mammograms.
Such notes could contain sensitive information, and there is concern that patients could be shocked, confused, or annoyed by what they read, even with more run-of-the-mill notes.
Champions of open notes say that the benefits, including better provider-patient communication, greatly outweigh such risks.
“This is about convenience – a bit like online banking,” commented Charlotte Blease, PhD, resident scholar at OpenNotes, an advocacy nonprofit organization headquartered at the Beth Israel–Deaconess Medical Center in Boston. “But it’s a culture shift for doctors,” she said in an interview.
“It turns physician paternalism on its head,” said C. T. Lin, MD, chief medical information officer, UCHealth, Denver. The change requires “some letting go of old traditions” in medicine, he wrote in an August blog post, referring to the fact that a computer screen – and not a physician – may tell patients about a new health problem.
Dr. Lin summarized the experience at the University of Colorado Cancer Center, which has allowed patients to have access to oncology notes for the past 5 years: “No issues and highly appreciated by patients. We have nothing to fear but fear itself.”
A new audience
Other institutions have also been voluntarily implementing open notes.
UC Davis Health in Sacramento, Calif., has run an optional program for the past year. However, only about two dozen of approximately 1,000 staff physicians opted in to the program.
“This illustrates the point that it’s a new thing that physicians aren’t used to doing. They’ve traditionally written notes for the benefit of their colleagues, for billing, for their own reference,” Scott MacDonald, MD, an internist and electronic health record medical director at UC Davis Health, told this news organization.
“They’ve never –until recently – had the patient as one of the audiences for a note,” he said.
Liam Keating, MD, an otolaryngologist in Martinez, Calif., recalls that he once wrote “globus hystericus,” and the patient wanted to sue him for saying that the patient was hysterical. “I now just code ‘Globus’ (if I don’t jump straight to LPD [lateral pharyngeal diverticulum]),” he commented in response to a commentary on open notes.
Sensitive information occurs more often in certain specialties, for example, psychiatry, genetics, adolescent medicine, and oncology, experts say.
“Cancer is an area that is highly charged for patients and doctors alike,” Dr. MacDonald pointed out. When reading pathology or imaging notes, patients may learn that they have been diagnosed with cancer or that they have a recurrence “without the physician being able to contextualize it and explain things – that’s just new and scary,” he said.
California law dictates that providers cannot post cancer test results without talking with the patient first, said Dr. MacDonald, but not all states have such laws.
Adjustments needed – or not – with open notes
At UCHealth in Aurora, Colo., Robert Breeze, MD, vice-chair of neurosurgery, said he has adjusted his practice to accommodate open notes and to anticipate trouble spots.*
“When I order imaging or send pathology specimens, I have already discussed with the patient the possibilities, including cancer, and what we will do next. Patients deeply appreciate these discussions, before they see the results,” he commented in an institutional white paper issued in anticipation of the changes on Nov. 2.
This is called precounseling, said Trent Rosenbloom, MD, MPH, director of patient portals at Vanderbilt University Medical Center, Nashville, Tenn., which has been a pioneer in information sharing with patients. Their system does delay the release of information in the case of “complicated” results, such as from cancer biopsies, he said in an interview.
However, Christiaan Hoff, MD, PhD, a surgeon at the Medical Center Leeuwarden (the Netherlands), wonders how important it is for the physician to be present when the patient receives bad news, including news about cancer. “We may overestimate our added value in these situations,” he suggested.
“Our empathy may not outweigh” the disadvantages of the situation, and the “finer points of our explanation will often go unnoticed” by the stressed patient, he commented. Dr. Hoff was also responding to the commentary about open notes.
In that commentary, Jack West, MD, a medical oncologist at City of Hope Cancer Center, Duarte, Calif., was concerned about misunderstandings. Oncology is complex, and patients can struggle to understand their prognosis and planned treatment efficacy, especially in cases of metastatic disease, he wrote.
This concern is somewhat refuted by a study published Oct. 5 in Cancer Cell. Responses to two surveys involving 96 oncology clinicians at three U.S. centers found that almost half (44%) believed that their patients “would be confused” by open notes.
However, only 4% of the 3,418 cancer patients from the same surveys reported being confused by open notes. (A majority of participants had more than a high school education, and English was their primary language.)
“Patient and clinician views about open notes in oncology are not aligned, with patients expressing considerably more enthusiasm,” wrote the authors, led by Liz Salmi, senior strategist at OpenNotes, who has been treated for brain cancer.
“All clinicians are anxious at first,” Ms. Salmi told this news organization. “Those patients who have more serious or chronic conditions … are more likely to read their notes.”
The survey results echo the early experience reported from Sweden, where open notes was launched in 2012. “Patients have loved it from the beginning,” said Maria Haggland, PhD, of Uppsala MedTech Science Innovation Center.
However, when the scheme first launched, it was considered to be “very controversial,” and “there were a lot of complaints, from health care professionals, especially,” she added.
Over time, clinicians have embraced open notes, and the program has 7.2 million patient accounts in a country of 10 million people, she observed during an Oct. 5 webinar on open notes.
More work for already overworked clinicians?
An outstanding concern about open notes is that it will cause more work for health care professionals.
Traditionally, doctors have written notes using medical lexicon, including a lot of abbreviations and jargon for efficiency’s sake. Now that patients will read the notes, will clinicians have to spell out things in lay terms, alter their writing so as not to offend, and generally do more work?
William Harvey, MD, chief medical information officer, Tufts Medical Center, Boston, acknowledged that that may be the case.
In a forthcoming note to staff about the Nov. 2 start of open notes, Dr. Harvey will include a reminder to accommodate the patient as a reader. But that may or may not mean an increase in work volume, depending on the provider. “Clinical note writing is highly personal. There’s an art to it,” he said in an interview. “So it’s hard to give standard advice.”
Steven Reidbord, MD, a psychiatrist in private practice in San Francisco and a lecturer at California Pacific Medical Center, is particularly concerned about the impact of open notes on progress notes, which he calls a tool to develop strategies and make observations while working with a patient.
By watering down the language for patients, “you are trading away the technical precision and other advantages of having a professional language,” he told this news organization.
“These notes serve many masters already,” he said, referring to purposes such as utilization review and billing. “The more masters they serve, the less useful they are to get medical work done.”
Dr. MacDonald, the medical information officer, said the new law doesn’t mandate a change in writing style.
In a study published last year, researchers analyzed notes written by oncologists before and after adoption of open notes. They found that, on average, clinicians did not change their note writing. The investigators analyzed more than 100,000 clinical notes written by 35 oncologists at a single center.
Advocates for open notes emphasize that there are benefits for clinicians.
“Doctors are overworked. They’re overburdened. But empowered patients can help the doctor,” said OpenNotes’ Dr. Blease. She cited survey data that show that patients better understand their treatment plan and medication, which can cut down on physician workload.
Open notes are “what you make of it,” said Marlene Millen, MD, an internist at UC San Diego Health, which has had a pilot program for 3 years. Each day, Dr. Millen discusses a shared note with two or three patients. “I actually end all of my appointments with, ‘Don’t forget to read your note later,’ ” she told this news organization.
“I was a little afraid of this initially,” she said, but within the first 3 months of the pilot, about 15 patients gave her direct feedback on how much they appreciated her notes. “It seemed to really reassure them that they were getting good care.”
The persons quoted in this article have disclosed no relevant financial relationships.
Correction, 10/23/20: An earlier version of this article misstated the campus' location.
A version of this article originally appeared on Medscape.com.
Starting Nov. 2, all patients in the United States will have immediate access to clinical notes and thus will be able to read their doctors’ writings, as well as test results and reports from pathology and imaging.
The 21st Century Cures Act mandates that patients have fast, electronic access to the following types of notes: consultations, discharge summaries, history, physical examination findings, imaging narratives, laboratory and pathology report narratives, and procedure and progress notes.
But this federal mandate, called “open notes” by many, is potentially confusing and frightening for patients, say some physicians. Others worry that the change will increase workload as clinicians tailor notes for patients and answer related questions.
The law means that inpatient and outpatient notes will be released immediately and that patients will have immediate access to testing and imaging results, including results from sexually transmitted disease tests, Pap tests, cancer biopsies, CT and PET scans, fetal ultrasounds, pneumonia cultures, and mammograms.
Such notes could contain sensitive information, and there is concern that patients could be shocked, confused, or annoyed by what they read, even with more run-of-the-mill notes.
Champions of open notes say that the benefits, including better provider-patient communication, greatly outweigh such risks.
“This is about convenience – a bit like online banking,” commented Charlotte Blease, PhD, resident scholar at OpenNotes, an advocacy nonprofit organization headquartered at the Beth Israel–Deaconess Medical Center in Boston. “But it’s a culture shift for doctors,” she said in an interview.
“It turns physician paternalism on its head,” said C. T. Lin, MD, chief medical information officer, UCHealth, Denver. The change requires “some letting go of old traditions” in medicine, he wrote in an August blog post, referring to the fact that a computer screen – and not a physician – may tell patients about a new health problem.
Dr. Lin summarized the experience at the University of Colorado Cancer Center, which has allowed patients to have access to oncology notes for the past 5 years: “No issues and highly appreciated by patients. We have nothing to fear but fear itself.”
A new audience
Other institutions have also been voluntarily implementing open notes.
UC Davis Health in Sacramento, Calif., has run an optional program for the past year. However, only about two dozen of approximately 1,000 staff physicians opted in to the program.
“This illustrates the point that it’s a new thing that physicians aren’t used to doing. They’ve traditionally written notes for the benefit of their colleagues, for billing, for their own reference,” Scott MacDonald, MD, an internist and electronic health record medical director at UC Davis Health, told this news organization.
“They’ve never –until recently – had the patient as one of the audiences for a note,” he said.
Liam Keating, MD, an otolaryngologist in Martinez, Calif., recalls that he once wrote “globus hystericus,” and the patient wanted to sue him for saying that the patient was hysterical. “I now just code ‘Globus’ (if I don’t jump straight to LPD [lateral pharyngeal diverticulum]),” he commented in response to a commentary on open notes.
Sensitive information occurs more often in certain specialties, for example, psychiatry, genetics, adolescent medicine, and oncology, experts say.
“Cancer is an area that is highly charged for patients and doctors alike,” Dr. MacDonald pointed out. When reading pathology or imaging notes, patients may learn that they have been diagnosed with cancer or that they have a recurrence “without the physician being able to contextualize it and explain things – that’s just new and scary,” he said.
California law dictates that providers cannot post cancer test results without talking with the patient first, said Dr. MacDonald, but not all states have such laws.
Adjustments needed – or not – with open notes
At UCHealth in Aurora, Colo., Robert Breeze, MD, vice-chair of neurosurgery, said he has adjusted his practice to accommodate open notes and to anticipate trouble spots.*
“When I order imaging or send pathology specimens, I have already discussed with the patient the possibilities, including cancer, and what we will do next. Patients deeply appreciate these discussions, before they see the results,” he commented in an institutional white paper issued in anticipation of the changes on Nov. 2.
This is called precounseling, said Trent Rosenbloom, MD, MPH, director of patient portals at Vanderbilt University Medical Center, Nashville, Tenn., which has been a pioneer in information sharing with patients. Their system does delay the release of information in the case of “complicated” results, such as from cancer biopsies, he said in an interview.
However, Christiaan Hoff, MD, PhD, a surgeon at the Medical Center Leeuwarden (the Netherlands), wonders how important it is for the physician to be present when the patient receives bad news, including news about cancer. “We may overestimate our added value in these situations,” he suggested.
“Our empathy may not outweigh” the disadvantages of the situation, and the “finer points of our explanation will often go unnoticed” by the stressed patient, he commented. Dr. Hoff was also responding to the commentary about open notes.
In that commentary, Jack West, MD, a medical oncologist at City of Hope Cancer Center, Duarte, Calif., was concerned about misunderstandings. Oncology is complex, and patients can struggle to understand their prognosis and planned treatment efficacy, especially in cases of metastatic disease, he wrote.
This concern is somewhat refuted by a study published Oct. 5 in Cancer Cell. Responses to two surveys involving 96 oncology clinicians at three U.S. centers found that almost half (44%) believed that their patients “would be confused” by open notes.
However, only 4% of the 3,418 cancer patients from the same surveys reported being confused by open notes. (A majority of participants had more than a high school education, and English was their primary language.)
“Patient and clinician views about open notes in oncology are not aligned, with patients expressing considerably more enthusiasm,” wrote the authors, led by Liz Salmi, senior strategist at OpenNotes, who has been treated for brain cancer.
“All clinicians are anxious at first,” Ms. Salmi told this news organization. “Those patients who have more serious or chronic conditions … are more likely to read their notes.”
The survey results echo the early experience reported from Sweden, where open notes was launched in 2012. “Patients have loved it from the beginning,” said Maria Haggland, PhD, of Uppsala MedTech Science Innovation Center.
However, when the scheme first launched, it was considered to be “very controversial,” and “there were a lot of complaints, from health care professionals, especially,” she added.
Over time, clinicians have embraced open notes, and the program has 7.2 million patient accounts in a country of 10 million people, she observed during an Oct. 5 webinar on open notes.
More work for already overworked clinicians?
An outstanding concern about open notes is that it will cause more work for health care professionals.
Traditionally, doctors have written notes using medical lexicon, including a lot of abbreviations and jargon for efficiency’s sake. Now that patients will read the notes, will clinicians have to spell out things in lay terms, alter their writing so as not to offend, and generally do more work?
William Harvey, MD, chief medical information officer, Tufts Medical Center, Boston, acknowledged that that may be the case.
In a forthcoming note to staff about the Nov. 2 start of open notes, Dr. Harvey will include a reminder to accommodate the patient as a reader. But that may or may not mean an increase in work volume, depending on the provider. “Clinical note writing is highly personal. There’s an art to it,” he said in an interview. “So it’s hard to give standard advice.”
Steven Reidbord, MD, a psychiatrist in private practice in San Francisco and a lecturer at California Pacific Medical Center, is particularly concerned about the impact of open notes on progress notes, which he calls a tool to develop strategies and make observations while working with a patient.
By watering down the language for patients, “you are trading away the technical precision and other advantages of having a professional language,” he told this news organization.
“These notes serve many masters already,” he said, referring to purposes such as utilization review and billing. “The more masters they serve, the less useful they are to get medical work done.”
Dr. MacDonald, the medical information officer, said the new law doesn’t mandate a change in writing style.
In a study published last year, researchers analyzed notes written by oncologists before and after adoption of open notes. They found that, on average, clinicians did not change their note writing. The investigators analyzed more than 100,000 clinical notes written by 35 oncologists at a single center.
Advocates for open notes emphasize that there are benefits for clinicians.
“Doctors are overworked. They’re overburdened. But empowered patients can help the doctor,” said OpenNotes’ Dr. Blease. She cited survey data that show that patients better understand their treatment plan and medication, which can cut down on physician workload.
Open notes are “what you make of it,” said Marlene Millen, MD, an internist at UC San Diego Health, which has had a pilot program for 3 years. Each day, Dr. Millen discusses a shared note with two or three patients. “I actually end all of my appointments with, ‘Don’t forget to read your note later,’ ” she told this news organization.
“I was a little afraid of this initially,” she said, but within the first 3 months of the pilot, about 15 patients gave her direct feedback on how much they appreciated her notes. “It seemed to really reassure them that they were getting good care.”
The persons quoted in this article have disclosed no relevant financial relationships.
Correction, 10/23/20: An earlier version of this article misstated the campus' location.
A version of this article originally appeared on Medscape.com.
Starting Nov. 2, all patients in the United States will have immediate access to clinical notes and thus will be able to read their doctors’ writings, as well as test results and reports from pathology and imaging.
The 21st Century Cures Act mandates that patients have fast, electronic access to the following types of notes: consultations, discharge summaries, history, physical examination findings, imaging narratives, laboratory and pathology report narratives, and procedure and progress notes.
But this federal mandate, called “open notes” by many, is potentially confusing and frightening for patients, say some physicians. Others worry that the change will increase workload as clinicians tailor notes for patients and answer related questions.
The law means that inpatient and outpatient notes will be released immediately and that patients will have immediate access to testing and imaging results, including results from sexually transmitted disease tests, Pap tests, cancer biopsies, CT and PET scans, fetal ultrasounds, pneumonia cultures, and mammograms.
Such notes could contain sensitive information, and there is concern that patients could be shocked, confused, or annoyed by what they read, even with more run-of-the-mill notes.
Champions of open notes say that the benefits, including better provider-patient communication, greatly outweigh such risks.
“This is about convenience – a bit like online banking,” commented Charlotte Blease, PhD, resident scholar at OpenNotes, an advocacy nonprofit organization headquartered at the Beth Israel–Deaconess Medical Center in Boston. “But it’s a culture shift for doctors,” she said in an interview.
“It turns physician paternalism on its head,” said C. T. Lin, MD, chief medical information officer, UCHealth, Denver. The change requires “some letting go of old traditions” in medicine, he wrote in an August blog post, referring to the fact that a computer screen – and not a physician – may tell patients about a new health problem.
Dr. Lin summarized the experience at the University of Colorado Cancer Center, which has allowed patients to have access to oncology notes for the past 5 years: “No issues and highly appreciated by patients. We have nothing to fear but fear itself.”
A new audience
Other institutions have also been voluntarily implementing open notes.
UC Davis Health in Sacramento, Calif., has run an optional program for the past year. However, only about two dozen of approximately 1,000 staff physicians opted in to the program.
“This illustrates the point that it’s a new thing that physicians aren’t used to doing. They’ve traditionally written notes for the benefit of their colleagues, for billing, for their own reference,” Scott MacDonald, MD, an internist and electronic health record medical director at UC Davis Health, told this news organization.
“They’ve never –until recently – had the patient as one of the audiences for a note,” he said.
Liam Keating, MD, an otolaryngologist in Martinez, Calif., recalls that he once wrote “globus hystericus,” and the patient wanted to sue him for saying that the patient was hysterical. “I now just code ‘Globus’ (if I don’t jump straight to LPD [lateral pharyngeal diverticulum]),” he commented in response to a commentary on open notes.
Sensitive information occurs more often in certain specialties, for example, psychiatry, genetics, adolescent medicine, and oncology, experts say.
“Cancer is an area that is highly charged for patients and doctors alike,” Dr. MacDonald pointed out. When reading pathology or imaging notes, patients may learn that they have been diagnosed with cancer or that they have a recurrence “without the physician being able to contextualize it and explain things – that’s just new and scary,” he said.
California law dictates that providers cannot post cancer test results without talking with the patient first, said Dr. MacDonald, but not all states have such laws.
Adjustments needed – or not – with open notes
At UCHealth in Aurora, Colo., Robert Breeze, MD, vice-chair of neurosurgery, said he has adjusted his practice to accommodate open notes and to anticipate trouble spots.*
“When I order imaging or send pathology specimens, I have already discussed with the patient the possibilities, including cancer, and what we will do next. Patients deeply appreciate these discussions, before they see the results,” he commented in an institutional white paper issued in anticipation of the changes on Nov. 2.
This is called precounseling, said Trent Rosenbloom, MD, MPH, director of patient portals at Vanderbilt University Medical Center, Nashville, Tenn., which has been a pioneer in information sharing with patients. Their system does delay the release of information in the case of “complicated” results, such as from cancer biopsies, he said in an interview.
However, Christiaan Hoff, MD, PhD, a surgeon at the Medical Center Leeuwarden (the Netherlands), wonders how important it is for the physician to be present when the patient receives bad news, including news about cancer. “We may overestimate our added value in these situations,” he suggested.
“Our empathy may not outweigh” the disadvantages of the situation, and the “finer points of our explanation will often go unnoticed” by the stressed patient, he commented. Dr. Hoff was also responding to the commentary about open notes.
In that commentary, Jack West, MD, a medical oncologist at City of Hope Cancer Center, Duarte, Calif., was concerned about misunderstandings. Oncology is complex, and patients can struggle to understand their prognosis and planned treatment efficacy, especially in cases of metastatic disease, he wrote.
This concern is somewhat refuted by a study published Oct. 5 in Cancer Cell. Responses to two surveys involving 96 oncology clinicians at three U.S. centers found that almost half (44%) believed that their patients “would be confused” by open notes.
However, only 4% of the 3,418 cancer patients from the same surveys reported being confused by open notes. (A majority of participants had more than a high school education, and English was their primary language.)
“Patient and clinician views about open notes in oncology are not aligned, with patients expressing considerably more enthusiasm,” wrote the authors, led by Liz Salmi, senior strategist at OpenNotes, who has been treated for brain cancer.
“All clinicians are anxious at first,” Ms. Salmi told this news organization. “Those patients who have more serious or chronic conditions … are more likely to read their notes.”
The survey results echo the early experience reported from Sweden, where open notes was launched in 2012. “Patients have loved it from the beginning,” said Maria Haggland, PhD, of Uppsala MedTech Science Innovation Center.
However, when the scheme first launched, it was considered to be “very controversial,” and “there were a lot of complaints, from health care professionals, especially,” she added.
Over time, clinicians have embraced open notes, and the program has 7.2 million patient accounts in a country of 10 million people, she observed during an Oct. 5 webinar on open notes.
More work for already overworked clinicians?
An outstanding concern about open notes is that it will cause more work for health care professionals.
Traditionally, doctors have written notes using medical lexicon, including a lot of abbreviations and jargon for efficiency’s sake. Now that patients will read the notes, will clinicians have to spell out things in lay terms, alter their writing so as not to offend, and generally do more work?
William Harvey, MD, chief medical information officer, Tufts Medical Center, Boston, acknowledged that that may be the case.
In a forthcoming note to staff about the Nov. 2 start of open notes, Dr. Harvey will include a reminder to accommodate the patient as a reader. But that may or may not mean an increase in work volume, depending on the provider. “Clinical note writing is highly personal. There’s an art to it,” he said in an interview. “So it’s hard to give standard advice.”
Steven Reidbord, MD, a psychiatrist in private practice in San Francisco and a lecturer at California Pacific Medical Center, is particularly concerned about the impact of open notes on progress notes, which he calls a tool to develop strategies and make observations while working with a patient.
By watering down the language for patients, “you are trading away the technical precision and other advantages of having a professional language,” he told this news organization.
“These notes serve many masters already,” he said, referring to purposes such as utilization review and billing. “The more masters they serve, the less useful they are to get medical work done.”
Dr. MacDonald, the medical information officer, said the new law doesn’t mandate a change in writing style.
In a study published last year, researchers analyzed notes written by oncologists before and after adoption of open notes. They found that, on average, clinicians did not change their note writing. The investigators analyzed more than 100,000 clinical notes written by 35 oncologists at a single center.
Advocates for open notes emphasize that there are benefits for clinicians.
“Doctors are overworked. They’re overburdened. But empowered patients can help the doctor,” said OpenNotes’ Dr. Blease. She cited survey data that show that patients better understand their treatment plan and medication, which can cut down on physician workload.
Open notes are “what you make of it,” said Marlene Millen, MD, an internist at UC San Diego Health, which has had a pilot program for 3 years. Each day, Dr. Millen discusses a shared note with two or three patients. “I actually end all of my appointments with, ‘Don’t forget to read your note later,’ ” she told this news organization.
“I was a little afraid of this initially,” she said, but within the first 3 months of the pilot, about 15 patients gave her direct feedback on how much they appreciated her notes. “It seemed to really reassure them that they were getting good care.”
The persons quoted in this article have disclosed no relevant financial relationships.
Correction, 10/23/20: An earlier version of this article misstated the campus' location.
A version of this article originally appeared on Medscape.com.
Popularity of virtual conferences may mean a permanent shift
Fifteen days. That’s how much time the American College of Cardiology (ACC) had to convert its annual conference, scheduled for the end of March this year in Chicago, into a virtual meeting for the estimated 17,000 people who had planned to attend.
Because of the coronavirus pandemic, Illinois announced restrictions on the size of gatherings on March 13, causing the ACC to pivot to an online-only model.
“One big advantage was that we already had all of our content planned,” Janice Sibley, the ACC’s executive vice president of education, told Medscape Medical News. “We knew who the faculty would be for different sessions, and many of them had already planned their slides.”
But determining how to present those hundreds of presentations at an online conference, not to mention addressing the logistics related to registrations, tech platforms, exhibit hall sponsors, and other aspects of an annual meeting, would be no small task.
But according to a Medscape poll, many physicians think that, while the virtual experience is worthwhile and getting better, it’s never going to be the same as spending several days on site, immersed in the experience of an annual meeting.
As one respondent commented, “I miss the intellectual excitement, the electricity in the room, when there is a live presentation that announces a major breakthrough.”
Large medical societies have an advantage
As ACC rapidly prepared for its virtual conference, the society first refunded all registration and expo fees and worked with the vendor partners to resolve the cancellation of rental space, food and beverage services, and decorating. Then they organized a team of 15 people split into three groups. One group focused on the intellectual, scientific, and educational elements of the virtual conference. They chose 24 sessions to livestream and decided to prerecord the rest for on-demand access, limiting the number of presenters they needed to train for online presentation.
A second team focused on business and worked with industry partners on how to translate a large expo into digital offerings. They developed virtual pages, advertisements, promotions, and industry-sponsored education.
The third team’s focus, Ms. Sibley said, was most critical, and the hardest: addressing socio-emotional needs.
“That group was responsible for trying to create the buzz and excitement we would have had at the event,” she said, “pivoting that experience we would have had in a live event to a virtual environment. What we were worried about was, would anyone even come?”
But ACC built it, and they did indeed come. Within a half hour of the opening session, nearly 13,000 people logged on from around the world. “It worked beautifully,” Ms. Sibley said.
By the end of the 3-day event, approximately 34,000 unique visitors had logged in for live or prerecorded sessions. Although ACC worried at first about technical glitches and bandwidth needs, everything ran smoothly. By 90 days after the meeting, 63,000 unique users had logged in to access the conference content.
ACC was among the first organizations forced to switch from an in-person to all-online meeting, but dozens of other organizations have now done the same, discovering the benefits and drawbacks of a virtual environment while experimenting with different formats and offerings. Talks with a few large medical societies about the experience revealed several common themes, including the following:
- Finding new ways to attract and measure attendance.
- Ensuring the actual scientific content was as robust online as in person.
- Realizing the value of social media in enhancing the socio-emotional experience.
- Believing that virtual meetings will become a permanent fixture in a future of “hybrid” conferences.
New ways of attracting and measuring attendance
Previous ways to measure meeting attendance were straightforward: number of registrations and number of people physically walking into sessions. An online conference, however, offers dozens of ways to measure attendance. While the number of registrations remained one tool – and all the organizations interviewed reported record numbers of registrations – organizations also used other metrics to measure success, such as “participation,” “engagement,” and “viewing time.”
ACC defined “participation” as a unique user logging in, and it defined “engagement” as sticking around for a while, possibly using chat functions or discussing the content on social media. The American Society of Clinical Oncology (ASCO) annual conference in May, which attracted more than 44,000 registered attendees, also measured total content views – more than 2.5 million during the meeting – and monitored social media. More than 8,800 Twitter users posted more than 45,000 tweets with the #ASCO20 hashtag during the meeting, generating 750 million likes, shares, and comments. The European League Against Rheumatism (EULAR) annual congress registered a record 18,700 delegates – up from 14,500 in 2019 – but it also measured attendance by average viewing time and visits by congress day and by category.
Organizations shifted fee structures as well. While ACC refunded fees for its first online meeting, it has since developed tiers to match fees to anticipated value, such as charging more for livestreamed sessions that allow interactivity than for viewing recordings. ASCO offered a one-time fee waiver for members plus free registration to cancer survivors and caregivers, discounted registration for patient advocates, and reduced fees for other categories. But adjusting how to measure attendance and charge for events were the easy parts of transitioning to online.
Priority for having robust content
The biggest difficulty for most organizations was the short time they had to move online, with a host of challenges accompanying the switch, said the executive director of EULAR, Julia Rautenstrauch, DrMed. These included technical requirements, communication, training, finances, legal issues, compliance rules, and other logistics.
“The year 2020 will be remembered for being the year of unexpected transformation,” said a spokesperson from European Society for Medical Oncology (ESMO), who declined to be named. “The number of fundamental questions we had to ask ourselves is pages long. The solutions we have implemented so far have been successful, but we won’t rest on our laurels.”
ASCO had an advantage in the pivot, despite only 6 weeks to make the switch, because they already had a robust online platform to build on. “We weren’t starting from scratch, but we were sure changing the way we prepared,” ASCO CEO Clifford Hudis, MD, said.
All of the organizations made the breadth and quality of scientific and educational content a top priority, and those who have already hosted meetings this year report positive feedback.
“The rating of the scientific content was excellent, and the event did indeed fulfill the educational goals and expected learning outcomes for the vast majority of delegates,” EULAR’s Dr. Rautenstrauch said.
“Our goal, when we went into this, was that, in the future when somebody looks back at ASCO20, they should not be able to tell that it was a different year from any other in terms of the science,” Dr. Hudis said.
Missing out on networking and social interaction
Even when logistics run smoothly, virtual conferences must overcome two other challenges: the loss of in-person interactions and the potential for “Zoom burnout.”
“You do miss that human contact, the unsaid reactions in the room when you’re speaking or providing a controversial statement, even the facial expression or seeing people lean in or being distracted,” Ms. Sibley said.
Taher Modarressi, MD, an endocrinologist with Diabetes and Endocrine Associates of Hunterdon in Flemington, N.J., said all the digital conferences he has attended were missing those key social elements: “seeing old friends, sideline discussions that generate new ideas, and meeting new colleagues. However, this has been partly alleviated with the robust rise of social media and ‘MedTwitter,’ in particular, where these discussions and interactions continue.”
To attempt to meet that need for social interaction, societies came up with a variety of options. EULAR offered chatrooms, “Meet the Expert” sessions, and other virtual opportunities for live interaction. ASCO hosted discussion groups with subsets of participants, such as virtual meetings with oncology fellows, and it plans to offer networking sessions and “poster walks” during future meetings.
“The value of an in-person meeting is connecting with people, exchanging ideas over coffee, and making new contacts,” ASCO’s Dr. Hudis said. While virtual meetings lose many of those personal interactions, knowledge can also be shared with more people, he said.
The key to combating digital fatigue is focusing on opportunities for interactivity, ACC’s Ms. Sibley said. “When you are creating a virtual environment, it’s important that you offer choices.” Online learners tend to have shorter attention spans than in-person learners, so people need opportunities to flip between sessions, like flipping between TV channels. Different engagement options are also essential, such as chat functions on the video platforms, asking questions of presenters orally or in writing, and using the familiar hashtags for social media discussion.
“We set up all those different ways to interact, and you allow the user to choose,” Ms. Sibley said.
Some conferences, however, had less time or fewer resources to adjust to a virtual format and couldn’t make up for the lost social interaction. Andy Bowman, MD, a neonatologist in Lubbock, Tex., was supposed to attend the Neonatal & Pediatric Airborne Transport Conference sponsored by International Biomed in the spring, but it was canceled at the last minute. Several weeks later, the organizers released videos of scheduled speakers giving their talks, but it was less engaging and too easy to get distracted, Dr. Bowman said.
“There is a noticeable decrease in energy – you can’t look around to feed off other’s reactions when a speaker says something off the wall, or new, or contrary to expectations,” he said. He also especially missed the social interactions, such as “missing out on the chance encounters in the hallway or seeing the same face in back-to-back sessions and figuring out you have shared interest.” He was also sorry to miss the expo because neonatal transport requires a lot of specialty equipment, and he appreciates the chance to actually touch and see it in person.
Advantages of an online meeting
Despite the challenges, online meetings can overcome obstacles of in-person meetings, particularly for those in low- and middle-income countries, such as travel and registration costs, the hardships of being away from practice, and visa restrictions.
“You really have the potential to broaden your reach,” Ms. Sibley said, noting that people in 157 countries participated in ACC.20.
Another advantage is keeping the experience available to people after the livestreamed event.
“Virtual events have demonstrated the potential for a more democratic conference world, expanding the dissemination of information to a much wider community of stakeholders,” ESMO’s spokesperson said.
Not traveling can actually mean getting more out of the conference, said Atisha Patel Manhas, MD, a hematologist/oncologist in Dallas, who attended ASCO. “I have really enjoyed the access aspect – on the virtual platform there is so much more content available to you, and travel time doesn’t cut into conference time,” she said, though she also missed the interaction with colleagues.
Others found that virtual conferences provided more engagement than in-person conferences. Marwah Abdalla, MD, MPH, an assistant professor of medicine and director of education for the Cardiac Intensive Care Unit at Columbia University Medical Center, New York, felt that moderated Q&A sessions offered more interaction among participants. She attended and spoke on a panel during virtual SLEEP 2020, a joint meeting of the American Academy of Sleep Medicine (AASM) and the Sleep Research Society (SRS).
“Usually during in-person sessions, only a few questions are possible, and participants rarely have an opportunity to discuss the presentations within the session due to time limits,” Dr. Abdalla said. “Because the conference presentations can also be viewed asynchronously, participants have been able to comment on lectures and continue the discussion offline, either via social media or via email.” She acknowledged drawbacks of the virtual experience, such as an inability to socialize in person and participate in activities but appreciated the new opportunities to network and learn from international colleagues who would not have been able to attend in person.
Ritu Thamman, MD, assistant professor of medicine at the University of Pittsburgh School of Medicine, pointed out that many institutions have cut their travel budgets, and physicians would be unable to attend in-person conferences for financial or other reasons. She especially appreciated that the European Society of Cardiology had no registration fee for ESC 2020 and made their content free for all of September, which led to more than 100,000 participants.
“That meant anyone anywhere could learn,” she said. “It makes it much more diverse and more egalitarian. That feels like a good step in the right direction for all of us.”
Dr. Modarressi, who found ESC “exhilarating,” similarly noted the benefit of such an equitably accessible conference. “Decreasing barriers and improving access to top-line results and up-to-date information has always been a challenge to the global health community,” he said, noting that the map of attendance for the virtual meeting was “astonishing.”
Given these benefits, organizers said they expect a future of hybrid conferences: physical meetings for those able to attend in person and virtual ones for those who cannot.
“We also expect that the hybrid congress will cater to the needs of people on-site by allowing them additional access to more scientific content than by physical attendance alone,” Dr. Rautenstrauch said.
Everyone has been in reactive mode this year, Ms. Sibley said, but the future looks bright as they seek ways to overcome challenges such as socio-emotional needs and virtual expo spaces.
“We’ve been thrust into the virtual world much faster than we expected, but we’re finding it’s opening more opportunities than we had live,” Ms. Sibley said. “This has catapulted us, for better or worse, into a new way to deliver education and other types of information.
“I think, if we’re smart, we’ll continue to think of ways this can augment our live environment and not replace it.”
A version of this article originally appeared on Medscape.com.
Fifteen days. That’s how much time the American College of Cardiology (ACC) had to convert its annual conference, scheduled for the end of March this year in Chicago, into a virtual meeting for the estimated 17,000 people who had planned to attend.
Because of the coronavirus pandemic, Illinois announced restrictions on the size of gatherings on March 13, causing the ACC to pivot to an online-only model.
“One big advantage was that we already had all of our content planned,” Janice Sibley, the ACC’s executive vice president of education, told Medscape Medical News. “We knew who the faculty would be for different sessions, and many of them had already planned their slides.”
But determining how to present those hundreds of presentations at an online conference, not to mention addressing the logistics related to registrations, tech platforms, exhibit hall sponsors, and other aspects of an annual meeting, would be no small task.
But according to a Medscape poll, many physicians think that, while the virtual experience is worthwhile and getting better, it’s never going to be the same as spending several days on site, immersed in the experience of an annual meeting.
As one respondent commented, “I miss the intellectual excitement, the electricity in the room, when there is a live presentation that announces a major breakthrough.”
Large medical societies have an advantage
As ACC rapidly prepared for its virtual conference, the society first refunded all registration and expo fees and worked with the vendor partners to resolve the cancellation of rental space, food and beverage services, and decorating. Then they organized a team of 15 people split into three groups. One group focused on the intellectual, scientific, and educational elements of the virtual conference. They chose 24 sessions to livestream and decided to prerecord the rest for on-demand access, limiting the number of presenters they needed to train for online presentation.
A second team focused on business and worked with industry partners on how to translate a large expo into digital offerings. They developed virtual pages, advertisements, promotions, and industry-sponsored education.
The third team’s focus, Ms. Sibley said, was most critical, and the hardest: addressing socio-emotional needs.
“That group was responsible for trying to create the buzz and excitement we would have had at the event,” she said, “pivoting that experience we would have had in a live event to a virtual environment. What we were worried about was, would anyone even come?”
But ACC built it, and they did indeed come. Within a half hour of the opening session, nearly 13,000 people logged on from around the world. “It worked beautifully,” Ms. Sibley said.
By the end of the 3-day event, approximately 34,000 unique visitors had logged in for live or prerecorded sessions. Although ACC worried at first about technical glitches and bandwidth needs, everything ran smoothly. By 90 days after the meeting, 63,000 unique users had logged in to access the conference content.
ACC was among the first organizations forced to switch from an in-person to all-online meeting, but dozens of other organizations have now done the same, discovering the benefits and drawbacks of a virtual environment while experimenting with different formats and offerings. Talks with a few large medical societies about the experience revealed several common themes, including the following:
- Finding new ways to attract and measure attendance.
- Ensuring the actual scientific content was as robust online as in person.
- Realizing the value of social media in enhancing the socio-emotional experience.
- Believing that virtual meetings will become a permanent fixture in a future of “hybrid” conferences.
New ways of attracting and measuring attendance
Previous ways to measure meeting attendance were straightforward: number of registrations and number of people physically walking into sessions. An online conference, however, offers dozens of ways to measure attendance. While the number of registrations remained one tool – and all the organizations interviewed reported record numbers of registrations – organizations also used other metrics to measure success, such as “participation,” “engagement,” and “viewing time.”
ACC defined “participation” as a unique user logging in, and it defined “engagement” as sticking around for a while, possibly using chat functions or discussing the content on social media. The American Society of Clinical Oncology (ASCO) annual conference in May, which attracted more than 44,000 registered attendees, also measured total content views – more than 2.5 million during the meeting – and monitored social media. More than 8,800 Twitter users posted more than 45,000 tweets with the #ASCO20 hashtag during the meeting, generating 750 million likes, shares, and comments. The European League Against Rheumatism (EULAR) annual congress registered a record 18,700 delegates – up from 14,500 in 2019 – but it also measured attendance by average viewing time and visits by congress day and by category.
Organizations shifted fee structures as well. While ACC refunded fees for its first online meeting, it has since developed tiers to match fees to anticipated value, such as charging more for livestreamed sessions that allow interactivity than for viewing recordings. ASCO offered a one-time fee waiver for members plus free registration to cancer survivors and caregivers, discounted registration for patient advocates, and reduced fees for other categories. But adjusting how to measure attendance and charge for events were the easy parts of transitioning to online.
Priority for having robust content
The biggest difficulty for most organizations was the short time they had to move online, with a host of challenges accompanying the switch, said the executive director of EULAR, Julia Rautenstrauch, DrMed. These included technical requirements, communication, training, finances, legal issues, compliance rules, and other logistics.
“The year 2020 will be remembered for being the year of unexpected transformation,” said a spokesperson from European Society for Medical Oncology (ESMO), who declined to be named. “The number of fundamental questions we had to ask ourselves is pages long. The solutions we have implemented so far have been successful, but we won’t rest on our laurels.”
ASCO had an advantage in the pivot, despite only 6 weeks to make the switch, because they already had a robust online platform to build on. “We weren’t starting from scratch, but we were sure changing the way we prepared,” ASCO CEO Clifford Hudis, MD, said.
All of the organizations made the breadth and quality of scientific and educational content a top priority, and those who have already hosted meetings this year report positive feedback.
“The rating of the scientific content was excellent, and the event did indeed fulfill the educational goals and expected learning outcomes for the vast majority of delegates,” EULAR’s Dr. Rautenstrauch said.
“Our goal, when we went into this, was that, in the future when somebody looks back at ASCO20, they should not be able to tell that it was a different year from any other in terms of the science,” Dr. Hudis said.
Missing out on networking and social interaction
Even when logistics run smoothly, virtual conferences must overcome two other challenges: the loss of in-person interactions and the potential for “Zoom burnout.”
“You do miss that human contact, the unsaid reactions in the room when you’re speaking or providing a controversial statement, even the facial expression or seeing people lean in or being distracted,” Ms. Sibley said.
Taher Modarressi, MD, an endocrinologist with Diabetes and Endocrine Associates of Hunterdon in Flemington, N.J., said all the digital conferences he has attended were missing those key social elements: “seeing old friends, sideline discussions that generate new ideas, and meeting new colleagues. However, this has been partly alleviated with the robust rise of social media and ‘MedTwitter,’ in particular, where these discussions and interactions continue.”
To attempt to meet that need for social interaction, societies came up with a variety of options. EULAR offered chatrooms, “Meet the Expert” sessions, and other virtual opportunities for live interaction. ASCO hosted discussion groups with subsets of participants, such as virtual meetings with oncology fellows, and it plans to offer networking sessions and “poster walks” during future meetings.
“The value of an in-person meeting is connecting with people, exchanging ideas over coffee, and making new contacts,” ASCO’s Dr. Hudis said. While virtual meetings lose many of those personal interactions, knowledge can also be shared with more people, he said.
The key to combating digital fatigue is focusing on opportunities for interactivity, ACC’s Ms. Sibley said. “When you are creating a virtual environment, it’s important that you offer choices.” Online learners tend to have shorter attention spans than in-person learners, so people need opportunities to flip between sessions, like flipping between TV channels. Different engagement options are also essential, such as chat functions on the video platforms, asking questions of presenters orally or in writing, and using the familiar hashtags for social media discussion.
“We set up all those different ways to interact, and you allow the user to choose,” Ms. Sibley said.
Some conferences, however, had less time or fewer resources to adjust to a virtual format and couldn’t make up for the lost social interaction. Andy Bowman, MD, a neonatologist in Lubbock, Tex., was supposed to attend the Neonatal & Pediatric Airborne Transport Conference sponsored by International Biomed in the spring, but it was canceled at the last minute. Several weeks later, the organizers released videos of scheduled speakers giving their talks, but it was less engaging and too easy to get distracted, Dr. Bowman said.
“There is a noticeable decrease in energy – you can’t look around to feed off other’s reactions when a speaker says something off the wall, or new, or contrary to expectations,” he said. He also especially missed the social interactions, such as “missing out on the chance encounters in the hallway or seeing the same face in back-to-back sessions and figuring out you have shared interest.” He was also sorry to miss the expo because neonatal transport requires a lot of specialty equipment, and he appreciates the chance to actually touch and see it in person.
Advantages of an online meeting
Despite the challenges, online meetings can overcome obstacles of in-person meetings, particularly for those in low- and middle-income countries, such as travel and registration costs, the hardships of being away from practice, and visa restrictions.
“You really have the potential to broaden your reach,” Ms. Sibley said, noting that people in 157 countries participated in ACC.20.
Another advantage is keeping the experience available to people after the livestreamed event.
“Virtual events have demonstrated the potential for a more democratic conference world, expanding the dissemination of information to a much wider community of stakeholders,” ESMO’s spokesperson said.
Not traveling can actually mean getting more out of the conference, said Atisha Patel Manhas, MD, a hematologist/oncologist in Dallas, who attended ASCO. “I have really enjoyed the access aspect – on the virtual platform there is so much more content available to you, and travel time doesn’t cut into conference time,” she said, though she also missed the interaction with colleagues.
Others found that virtual conferences provided more engagement than in-person conferences. Marwah Abdalla, MD, MPH, an assistant professor of medicine and director of education for the Cardiac Intensive Care Unit at Columbia University Medical Center, New York, felt that moderated Q&A sessions offered more interaction among participants. She attended and spoke on a panel during virtual SLEEP 2020, a joint meeting of the American Academy of Sleep Medicine (AASM) and the Sleep Research Society (SRS).
“Usually during in-person sessions, only a few questions are possible, and participants rarely have an opportunity to discuss the presentations within the session due to time limits,” Dr. Abdalla said. “Because the conference presentations can also be viewed asynchronously, participants have been able to comment on lectures and continue the discussion offline, either via social media or via email.” She acknowledged drawbacks of the virtual experience, such as an inability to socialize in person and participate in activities but appreciated the new opportunities to network and learn from international colleagues who would not have been able to attend in person.
Ritu Thamman, MD, assistant professor of medicine at the University of Pittsburgh School of Medicine, pointed out that many institutions have cut their travel budgets, and physicians would be unable to attend in-person conferences for financial or other reasons. She especially appreciated that the European Society of Cardiology had no registration fee for ESC 2020 and made their content free for all of September, which led to more than 100,000 participants.
“That meant anyone anywhere could learn,” she said. “It makes it much more diverse and more egalitarian. That feels like a good step in the right direction for all of us.”
Dr. Modarressi, who found ESC “exhilarating,” similarly noted the benefit of such an equitably accessible conference. “Decreasing barriers and improving access to top-line results and up-to-date information has always been a challenge to the global health community,” he said, noting that the map of attendance for the virtual meeting was “astonishing.”
Given these benefits, organizers said they expect a future of hybrid conferences: physical meetings for those able to attend in person and virtual ones for those who cannot.
“We also expect that the hybrid congress will cater to the needs of people on-site by allowing them additional access to more scientific content than by physical attendance alone,” Dr. Rautenstrauch said.
Everyone has been in reactive mode this year, Ms. Sibley said, but the future looks bright as they seek ways to overcome challenges such as socio-emotional needs and virtual expo spaces.
“We’ve been thrust into the virtual world much faster than we expected, but we’re finding it’s opening more opportunities than we had live,” Ms. Sibley said. “This has catapulted us, for better or worse, into a new way to deliver education and other types of information.
“I think, if we’re smart, we’ll continue to think of ways this can augment our live environment and not replace it.”
A version of this article originally appeared on Medscape.com.
Fifteen days. That’s how much time the American College of Cardiology (ACC) had to convert its annual conference, scheduled for the end of March this year in Chicago, into a virtual meeting for the estimated 17,000 people who had planned to attend.
Because of the coronavirus pandemic, Illinois announced restrictions on the size of gatherings on March 13, causing the ACC to pivot to an online-only model.
“One big advantage was that we already had all of our content planned,” Janice Sibley, the ACC’s executive vice president of education, told Medscape Medical News. “We knew who the faculty would be for different sessions, and many of them had already planned their slides.”
But determining how to present those hundreds of presentations at an online conference, not to mention addressing the logistics related to registrations, tech platforms, exhibit hall sponsors, and other aspects of an annual meeting, would be no small task.
But according to a Medscape poll, many physicians think that, while the virtual experience is worthwhile and getting better, it’s never going to be the same as spending several days on site, immersed in the experience of an annual meeting.
As one respondent commented, “I miss the intellectual excitement, the electricity in the room, when there is a live presentation that announces a major breakthrough.”
Large medical societies have an advantage
As ACC rapidly prepared for its virtual conference, the society first refunded all registration and expo fees and worked with the vendor partners to resolve the cancellation of rental space, food and beverage services, and decorating. Then they organized a team of 15 people split into three groups. One group focused on the intellectual, scientific, and educational elements of the virtual conference. They chose 24 sessions to livestream and decided to prerecord the rest for on-demand access, limiting the number of presenters they needed to train for online presentation.
A second team focused on business and worked with industry partners on how to translate a large expo into digital offerings. They developed virtual pages, advertisements, promotions, and industry-sponsored education.
The third team’s focus, Ms. Sibley said, was most critical, and the hardest: addressing socio-emotional needs.
“That group was responsible for trying to create the buzz and excitement we would have had at the event,” she said, “pivoting that experience we would have had in a live event to a virtual environment. What we were worried about was, would anyone even come?”
But ACC built it, and they did indeed come. Within a half hour of the opening session, nearly 13,000 people logged on from around the world. “It worked beautifully,” Ms. Sibley said.
By the end of the 3-day event, approximately 34,000 unique visitors had logged in for live or prerecorded sessions. Although ACC worried at first about technical glitches and bandwidth needs, everything ran smoothly. By 90 days after the meeting, 63,000 unique users had logged in to access the conference content.
ACC was among the first organizations forced to switch from an in-person to all-online meeting, but dozens of other organizations have now done the same, discovering the benefits and drawbacks of a virtual environment while experimenting with different formats and offerings. Talks with a few large medical societies about the experience revealed several common themes, including the following:
- Finding new ways to attract and measure attendance.
- Ensuring the actual scientific content was as robust online as in person.
- Realizing the value of social media in enhancing the socio-emotional experience.
- Believing that virtual meetings will become a permanent fixture in a future of “hybrid” conferences.
New ways of attracting and measuring attendance
Previous ways to measure meeting attendance were straightforward: number of registrations and number of people physically walking into sessions. An online conference, however, offers dozens of ways to measure attendance. While the number of registrations remained one tool – and all the organizations interviewed reported record numbers of registrations – organizations also used other metrics to measure success, such as “participation,” “engagement,” and “viewing time.”
ACC defined “participation” as a unique user logging in, and it defined “engagement” as sticking around for a while, possibly using chat functions or discussing the content on social media. The American Society of Clinical Oncology (ASCO) annual conference in May, which attracted more than 44,000 registered attendees, also measured total content views – more than 2.5 million during the meeting – and monitored social media. More than 8,800 Twitter users posted more than 45,000 tweets with the #ASCO20 hashtag during the meeting, generating 750 million likes, shares, and comments. The European League Against Rheumatism (EULAR) annual congress registered a record 18,700 delegates – up from 14,500 in 2019 – but it also measured attendance by average viewing time and visits by congress day and by category.
Organizations shifted fee structures as well. While ACC refunded fees for its first online meeting, it has since developed tiers to match fees to anticipated value, such as charging more for livestreamed sessions that allow interactivity than for viewing recordings. ASCO offered a one-time fee waiver for members plus free registration to cancer survivors and caregivers, discounted registration for patient advocates, and reduced fees for other categories. But adjusting how to measure attendance and charge for events were the easy parts of transitioning to online.
Priority for having robust content
The biggest difficulty for most organizations was the short time they had to move online, with a host of challenges accompanying the switch, said the executive director of EULAR, Julia Rautenstrauch, DrMed. These included technical requirements, communication, training, finances, legal issues, compliance rules, and other logistics.
“The year 2020 will be remembered for being the year of unexpected transformation,” said a spokesperson from European Society for Medical Oncology (ESMO), who declined to be named. “The number of fundamental questions we had to ask ourselves is pages long. The solutions we have implemented so far have been successful, but we won’t rest on our laurels.”
ASCO had an advantage in the pivot, despite only 6 weeks to make the switch, because they already had a robust online platform to build on. “We weren’t starting from scratch, but we were sure changing the way we prepared,” ASCO CEO Clifford Hudis, MD, said.
All of the organizations made the breadth and quality of scientific and educational content a top priority, and those who have already hosted meetings this year report positive feedback.
“The rating of the scientific content was excellent, and the event did indeed fulfill the educational goals and expected learning outcomes for the vast majority of delegates,” EULAR’s Dr. Rautenstrauch said.
“Our goal, when we went into this, was that, in the future when somebody looks back at ASCO20, they should not be able to tell that it was a different year from any other in terms of the science,” Dr. Hudis said.
Missing out on networking and social interaction
Even when logistics run smoothly, virtual conferences must overcome two other challenges: the loss of in-person interactions and the potential for “Zoom burnout.”
“You do miss that human contact, the unsaid reactions in the room when you’re speaking or providing a controversial statement, even the facial expression or seeing people lean in or being distracted,” Ms. Sibley said.
Taher Modarressi, MD, an endocrinologist with Diabetes and Endocrine Associates of Hunterdon in Flemington, N.J., said all the digital conferences he has attended were missing those key social elements: “seeing old friends, sideline discussions that generate new ideas, and meeting new colleagues. However, this has been partly alleviated with the robust rise of social media and ‘MedTwitter,’ in particular, where these discussions and interactions continue.”
To attempt to meet that need for social interaction, societies came up with a variety of options. EULAR offered chatrooms, “Meet the Expert” sessions, and other virtual opportunities for live interaction. ASCO hosted discussion groups with subsets of participants, such as virtual meetings with oncology fellows, and it plans to offer networking sessions and “poster walks” during future meetings.
“The value of an in-person meeting is connecting with people, exchanging ideas over coffee, and making new contacts,” ASCO’s Dr. Hudis said. While virtual meetings lose many of those personal interactions, knowledge can also be shared with more people, he said.
The key to combating digital fatigue is focusing on opportunities for interactivity, ACC’s Ms. Sibley said. “When you are creating a virtual environment, it’s important that you offer choices.” Online learners tend to have shorter attention spans than in-person learners, so people need opportunities to flip between sessions, like flipping between TV channels. Different engagement options are also essential, such as chat functions on the video platforms, asking questions of presenters orally or in writing, and using the familiar hashtags for social media discussion.
“We set up all those different ways to interact, and you allow the user to choose,” Ms. Sibley said.
Some conferences, however, had less time or fewer resources to adjust to a virtual format and couldn’t make up for the lost social interaction. Andy Bowman, MD, a neonatologist in Lubbock, Tex., was supposed to attend the Neonatal & Pediatric Airborne Transport Conference sponsored by International Biomed in the spring, but it was canceled at the last minute. Several weeks later, the organizers released videos of scheduled speakers giving their talks, but it was less engaging and too easy to get distracted, Dr. Bowman said.
“There is a noticeable decrease in energy – you can’t look around to feed off other’s reactions when a speaker says something off the wall, or new, or contrary to expectations,” he said. He also especially missed the social interactions, such as “missing out on the chance encounters in the hallway or seeing the same face in back-to-back sessions and figuring out you have shared interest.” He was also sorry to miss the expo because neonatal transport requires a lot of specialty equipment, and he appreciates the chance to actually touch and see it in person.
Advantages of an online meeting
Despite the challenges, online meetings can overcome obstacles of in-person meetings, particularly for those in low- and middle-income countries, such as travel and registration costs, the hardships of being away from practice, and visa restrictions.
“You really have the potential to broaden your reach,” Ms. Sibley said, noting that people in 157 countries participated in ACC.20.
Another advantage is keeping the experience available to people after the livestreamed event.
“Virtual events have demonstrated the potential for a more democratic conference world, expanding the dissemination of information to a much wider community of stakeholders,” ESMO’s spokesperson said.
Not traveling can actually mean getting more out of the conference, said Atisha Patel Manhas, MD, a hematologist/oncologist in Dallas, who attended ASCO. “I have really enjoyed the access aspect – on the virtual platform there is so much more content available to you, and travel time doesn’t cut into conference time,” she said, though she also missed the interaction with colleagues.
Others found that virtual conferences provided more engagement than in-person conferences. Marwah Abdalla, MD, MPH, an assistant professor of medicine and director of education for the Cardiac Intensive Care Unit at Columbia University Medical Center, New York, felt that moderated Q&A sessions offered more interaction among participants. She attended and spoke on a panel during virtual SLEEP 2020, a joint meeting of the American Academy of Sleep Medicine (AASM) and the Sleep Research Society (SRS).
“Usually during in-person sessions, only a few questions are possible, and participants rarely have an opportunity to discuss the presentations within the session due to time limits,” Dr. Abdalla said. “Because the conference presentations can also be viewed asynchronously, participants have been able to comment on lectures and continue the discussion offline, either via social media or via email.” She acknowledged drawbacks of the virtual experience, such as an inability to socialize in person and participate in activities but appreciated the new opportunities to network and learn from international colleagues who would not have been able to attend in person.
Ritu Thamman, MD, assistant professor of medicine at the University of Pittsburgh School of Medicine, pointed out that many institutions have cut their travel budgets, and physicians would be unable to attend in-person conferences for financial or other reasons. She especially appreciated that the European Society of Cardiology had no registration fee for ESC 2020 and made their content free for all of September, which led to more than 100,000 participants.
“That meant anyone anywhere could learn,” she said. “It makes it much more diverse and more egalitarian. That feels like a good step in the right direction for all of us.”
Dr. Modarressi, who found ESC “exhilarating,” similarly noted the benefit of such an equitably accessible conference. “Decreasing barriers and improving access to top-line results and up-to-date information has always been a challenge to the global health community,” he said, noting that the map of attendance for the virtual meeting was “astonishing.”
Given these benefits, organizers said they expect a future of hybrid conferences: physical meetings for those able to attend in person and virtual ones for those who cannot.
“We also expect that the hybrid congress will cater to the needs of people on-site by allowing them additional access to more scientific content than by physical attendance alone,” Dr. Rautenstrauch said.
Everyone has been in reactive mode this year, Ms. Sibley said, but the future looks bright as they seek ways to overcome challenges such as socio-emotional needs and virtual expo spaces.
“We’ve been thrust into the virtual world much faster than we expected, but we’re finding it’s opening more opportunities than we had live,” Ms. Sibley said. “This has catapulted us, for better or worse, into a new way to deliver education and other types of information.
“I think, if we’re smart, we’ll continue to think of ways this can augment our live environment and not replace it.”
A version of this article originally appeared on Medscape.com.
Cardiogenic shock rate soars in COVID-positive ACS
COVID-19–positive patients undergoing an invasive strategy for acute coronary syndrome presented hours later than uninfected historical controls, had a far higher incidence of cardiogenic shock, and their in-hospital mortality rate was four- to fivefold greater, according to data from the Global Multicenter Prospective COVID–ACS Registry. These phenomena are probably interrelated, according to Anthony Gershlick, MBBS, who presented the registry results at the Transcatheter Cardiovascular Therapeutics virtual annual meeting.
“We know that increasing ischemic time leads to bigger infarcts. And we know that bigger infarcts lead to cardiogenic shock, with its known higher mortality,” said Dr. Gershlick, professor of interventional cardiology at the University of Leicester (England).
“These data suggest that patients may have presented late, likely due to COVID concerns, and they had worse outcomes. If these data are borne out, future public information strategies need to be reassuring, proactive, simple, and more effective because we think patients stayed away,” the cardiologist added. “There are important public information messages to be taken from these data about getting patients to come to hospital during such pandemics.”
He presented prospectively collected registry data on 144 patients with confirmed ST-elevation MI (STEMI) and 122 with non-ST–elevation MI (NSTEMI), all COVID-19 positive on presentation at 85 hospitals in the United Kingdom, Europe, and North America during March through August of 2020. Since the initial message to the public early in the pandemic in many places was to try to avoid the hospital, the investigators selected for their no-COVID comparison group the data on more than 22,000 STEMI and NSTEMI patients included in two British national databases covering 2018-2019.
The COVID-positive STEMI patients were significantly younger, had more comorbidities, and had a higher mean heart rate and lower systolic blood pressure at admission than the non-COVID STEMI control group. Their median time from symptom onset to admission was 339 minutes, compared with 178 minutes in controls. Their door-to-balloon time averaged 83 minutes, versus 37 minutes in the era before the pandemic.
“I suspect that’s got something to do with the donning and doffing of personal protective equipment,” he said at the meeting sponsored by the Cardiovascular Research Foundation.
The in-hospital mortality rates were strikingly different: 27.1% in COVID-positive STEMI patients versus 5.7% in controls. Bleeding Academic Research Consortium type 3-5 bleeding was increased as well, by a margin of 2.8% to 0.3%. So was stroke, with a 2.1% in-hospital incidence in COVID-positive STEMI patients and a 0.1% rate in the comparator arm.
“But the biggest headline here for me was that the cardiogenic shock rate was 20.1% in the COVID-positive patients versus 8.7% in the non-COVID STEMI patients,” the cardiologist continued.
The same pattern held true among the COVID-positive NSTEMI patients: They were younger, sicker, and slower to present to the hospital than the non-COVID group. The in-hospital mortality rate was 6.6% in the COVID-positive NSTEMI patients, compared with 1.2% in the reference group. The COVID-positive patients had a 2.5% bleeding rate versus 0.1% in the controls. And the incidence of cardiogenic shock was 5%, compared with 1.4% in the controls from before the pandemic.
“Even though NSTEMI is traditionally regarded as lower risk, this is really quite dramatic. These are sick patients,” Dr. Gershlick observed.
Nearly two-thirds of in-hospital deaths in COVID-positive ACS patients were cardiovascular, and three-quarters of those cardiovascular deaths occurred in patients with cardiogenic shock. Thirty-two percent of deaths in COVID-positive ACS patients were of respiratory causes, and 4.9% were neurologic.
Notably, the ischemic time of patients with cardiogenic shock who died – that is, the time from symptom onset to balloon deployment – averaged 1,271 minutes, compared with 441 minutes in those who died without being in cardiogenic shock.
Session comoderator Sahil A. Parikh, MD, director of endovascular services at Columbia University Medical Center in New York, commented, “One of the striking things that is resonating with me is the high incidence of cardiogenic shock and the mortality. It’s akin to what we’ve seen in New York.”
Discussant Valentin Fuster, MD, PhD, said he doubts that the increased in-hospital mortality in the COVID–ACS registry is related to the prolonged time to presentation at the hospital. More likely, it’s related to the greater thrombotic burden various studies have shown accompanies COVID-positive ACS. It might even be caused by a direct effect of the virus on the myocardium, added Dr. Fuster, director of the Zena and Michael A. Wiener Cardiovascular Institute and professor of medicine at the Icahn School of Medicine at Mount Sinai in New York.
“I have to say I absolutely disagree,” responded Dr. Gershlick. “I think it’s important that we try to understand all the mechanisms, but we know that patients with COVID are anxious, and I think one of the messages from this registry is patients took longer to come to hospital, they were sicker, they had more cardiogenic shock, and they died. And I don’t think it’s anything more complicated than that.”
Another discussant, Mamas Mamas, MD, is involved with a 500-patient U.K. pandemic ACS registry nearing publication. The findings, he said, are similar to what Dr. Gershlick reported in terms of the high rate of presentation with cardiogenic shock and elevated in-hospital mortality. The COVID-positive ACS patients were also more likely to present with out-of-hospital cardiac arrest. But like Dr. Fuster, he is skeptical that their worse outcomes can be explained by a delay in seeking care.
“I don’t think the delay in presentation is really associated with the high mortality rate that we see. The delay in our U.K. registry is maybe half an hour for STEMIs and maybe 2-3 hours for NSTEMIs. And I don’t think that can produce a 30%-40% increase in mortality,” asserted Dr. Mamas, professor of cardiology at Keele University in Staffordshire, England.
Dr. Gershlick reported having no financial conflicts regarding his presentation.
COVID-19–positive patients undergoing an invasive strategy for acute coronary syndrome presented hours later than uninfected historical controls, had a far higher incidence of cardiogenic shock, and their in-hospital mortality rate was four- to fivefold greater, according to data from the Global Multicenter Prospective COVID–ACS Registry. These phenomena are probably interrelated, according to Anthony Gershlick, MBBS, who presented the registry results at the Transcatheter Cardiovascular Therapeutics virtual annual meeting.
“We know that increasing ischemic time leads to bigger infarcts. And we know that bigger infarcts lead to cardiogenic shock, with its known higher mortality,” said Dr. Gershlick, professor of interventional cardiology at the University of Leicester (England).
“These data suggest that patients may have presented late, likely due to COVID concerns, and they had worse outcomes. If these data are borne out, future public information strategies need to be reassuring, proactive, simple, and more effective because we think patients stayed away,” the cardiologist added. “There are important public information messages to be taken from these data about getting patients to come to hospital during such pandemics.”
He presented prospectively collected registry data on 144 patients with confirmed ST-elevation MI (STEMI) and 122 with non-ST–elevation MI (NSTEMI), all COVID-19 positive on presentation at 85 hospitals in the United Kingdom, Europe, and North America during March through August of 2020. Since the initial message to the public early in the pandemic in many places was to try to avoid the hospital, the investigators selected for their no-COVID comparison group the data on more than 22,000 STEMI and NSTEMI patients included in two British national databases covering 2018-2019.
The COVID-positive STEMI patients were significantly younger, had more comorbidities, and had a higher mean heart rate and lower systolic blood pressure at admission than the non-COVID STEMI control group. Their median time from symptom onset to admission was 339 minutes, compared with 178 minutes in controls. Their door-to-balloon time averaged 83 minutes, versus 37 minutes in the era before the pandemic.
“I suspect that’s got something to do with the donning and doffing of personal protective equipment,” he said at the meeting sponsored by the Cardiovascular Research Foundation.
The in-hospital mortality rates were strikingly different: 27.1% in COVID-positive STEMI patients versus 5.7% in controls. Bleeding Academic Research Consortium type 3-5 bleeding was increased as well, by a margin of 2.8% to 0.3%. So was stroke, with a 2.1% in-hospital incidence in COVID-positive STEMI patients and a 0.1% rate in the comparator arm.
“But the biggest headline here for me was that the cardiogenic shock rate was 20.1% in the COVID-positive patients versus 8.7% in the non-COVID STEMI patients,” the cardiologist continued.
The same pattern held true among the COVID-positive NSTEMI patients: They were younger, sicker, and slower to present to the hospital than the non-COVID group. The in-hospital mortality rate was 6.6% in the COVID-positive NSTEMI patients, compared with 1.2% in the reference group. The COVID-positive patients had a 2.5% bleeding rate versus 0.1% in the controls. And the incidence of cardiogenic shock was 5%, compared with 1.4% in the controls from before the pandemic.
“Even though NSTEMI is traditionally regarded as lower risk, this is really quite dramatic. These are sick patients,” Dr. Gershlick observed.
Nearly two-thirds of in-hospital deaths in COVID-positive ACS patients were cardiovascular, and three-quarters of those cardiovascular deaths occurred in patients with cardiogenic shock. Thirty-two percent of deaths in COVID-positive ACS patients were of respiratory causes, and 4.9% were neurologic.
Notably, the ischemic time of patients with cardiogenic shock who died – that is, the time from symptom onset to balloon deployment – averaged 1,271 minutes, compared with 441 minutes in those who died without being in cardiogenic shock.
Session comoderator Sahil A. Parikh, MD, director of endovascular services at Columbia University Medical Center in New York, commented, “One of the striking things that is resonating with me is the high incidence of cardiogenic shock and the mortality. It’s akin to what we’ve seen in New York.”
Discussant Valentin Fuster, MD, PhD, said he doubts that the increased in-hospital mortality in the COVID–ACS registry is related to the prolonged time to presentation at the hospital. More likely, it’s related to the greater thrombotic burden various studies have shown accompanies COVID-positive ACS. It might even be caused by a direct effect of the virus on the myocardium, added Dr. Fuster, director of the Zena and Michael A. Wiener Cardiovascular Institute and professor of medicine at the Icahn School of Medicine at Mount Sinai in New York.
“I have to say I absolutely disagree,” responded Dr. Gershlick. “I think it’s important that we try to understand all the mechanisms, but we know that patients with COVID are anxious, and I think one of the messages from this registry is patients took longer to come to hospital, they were sicker, they had more cardiogenic shock, and they died. And I don’t think it’s anything more complicated than that.”
Another discussant, Mamas Mamas, MD, is involved with a 500-patient U.K. pandemic ACS registry nearing publication. The findings, he said, are similar to what Dr. Gershlick reported in terms of the high rate of presentation with cardiogenic shock and elevated in-hospital mortality. The COVID-positive ACS patients were also more likely to present with out-of-hospital cardiac arrest. But like Dr. Fuster, he is skeptical that their worse outcomes can be explained by a delay in seeking care.
“I don’t think the delay in presentation is really associated with the high mortality rate that we see. The delay in our U.K. registry is maybe half an hour for STEMIs and maybe 2-3 hours for NSTEMIs. And I don’t think that can produce a 30%-40% increase in mortality,” asserted Dr. Mamas, professor of cardiology at Keele University in Staffordshire, England.
Dr. Gershlick reported having no financial conflicts regarding his presentation.
COVID-19–positive patients undergoing an invasive strategy for acute coronary syndrome presented hours later than uninfected historical controls, had a far higher incidence of cardiogenic shock, and their in-hospital mortality rate was four- to fivefold greater, according to data from the Global Multicenter Prospective COVID–ACS Registry. These phenomena are probably interrelated, according to Anthony Gershlick, MBBS, who presented the registry results at the Transcatheter Cardiovascular Therapeutics virtual annual meeting.
“We know that increasing ischemic time leads to bigger infarcts. And we know that bigger infarcts lead to cardiogenic shock, with its known higher mortality,” said Dr. Gershlick, professor of interventional cardiology at the University of Leicester (England).
“These data suggest that patients may have presented late, likely due to COVID concerns, and they had worse outcomes. If these data are borne out, future public information strategies need to be reassuring, proactive, simple, and more effective because we think patients stayed away,” the cardiologist added. “There are important public information messages to be taken from these data about getting patients to come to hospital during such pandemics.”
He presented prospectively collected registry data on 144 patients with confirmed ST-elevation MI (STEMI) and 122 with non-ST–elevation MI (NSTEMI), all COVID-19 positive on presentation at 85 hospitals in the United Kingdom, Europe, and North America during March through August of 2020. Since the initial message to the public early in the pandemic in many places was to try to avoid the hospital, the investigators selected for their no-COVID comparison group the data on more than 22,000 STEMI and NSTEMI patients included in two British national databases covering 2018-2019.
The COVID-positive STEMI patients were significantly younger, had more comorbidities, and had a higher mean heart rate and lower systolic blood pressure at admission than the non-COVID STEMI control group. Their median time from symptom onset to admission was 339 minutes, compared with 178 minutes in controls. Their door-to-balloon time averaged 83 minutes, versus 37 minutes in the era before the pandemic.
“I suspect that’s got something to do with the donning and doffing of personal protective equipment,” he said at the meeting sponsored by the Cardiovascular Research Foundation.
The in-hospital mortality rates were strikingly different: 27.1% in COVID-positive STEMI patients versus 5.7% in controls. Bleeding Academic Research Consortium type 3-5 bleeding was increased as well, by a margin of 2.8% to 0.3%. So was stroke, with a 2.1% in-hospital incidence in COVID-positive STEMI patients and a 0.1% rate in the comparator arm.
“But the biggest headline here for me was that the cardiogenic shock rate was 20.1% in the COVID-positive patients versus 8.7% in the non-COVID STEMI patients,” the cardiologist continued.
The same pattern held true among the COVID-positive NSTEMI patients: They were younger, sicker, and slower to present to the hospital than the non-COVID group. The in-hospital mortality rate was 6.6% in the COVID-positive NSTEMI patients, compared with 1.2% in the reference group. The COVID-positive patients had a 2.5% bleeding rate versus 0.1% in the controls. And the incidence of cardiogenic shock was 5%, compared with 1.4% in the controls from before the pandemic.
“Even though NSTEMI is traditionally regarded as lower risk, this is really quite dramatic. These are sick patients,” Dr. Gershlick observed.
Nearly two-thirds of in-hospital deaths in COVID-positive ACS patients were cardiovascular, and three-quarters of those cardiovascular deaths occurred in patients with cardiogenic shock. Thirty-two percent of deaths in COVID-positive ACS patients were of respiratory causes, and 4.9% were neurologic.
Notably, the ischemic time of patients with cardiogenic shock who died – that is, the time from symptom onset to balloon deployment – averaged 1,271 minutes, compared with 441 minutes in those who died without being in cardiogenic shock.
Session comoderator Sahil A. Parikh, MD, director of endovascular services at Columbia University Medical Center in New York, commented, “One of the striking things that is resonating with me is the high incidence of cardiogenic shock and the mortality. It’s akin to what we’ve seen in New York.”
Discussant Valentin Fuster, MD, PhD, said he doubts that the increased in-hospital mortality in the COVID–ACS registry is related to the prolonged time to presentation at the hospital. More likely, it’s related to the greater thrombotic burden various studies have shown accompanies COVID-positive ACS. It might even be caused by a direct effect of the virus on the myocardium, added Dr. Fuster, director of the Zena and Michael A. Wiener Cardiovascular Institute and professor of medicine at the Icahn School of Medicine at Mount Sinai in New York.
“I have to say I absolutely disagree,” responded Dr. Gershlick. “I think it’s important that we try to understand all the mechanisms, but we know that patients with COVID are anxious, and I think one of the messages from this registry is patients took longer to come to hospital, they were sicker, they had more cardiogenic shock, and they died. And I don’t think it’s anything more complicated than that.”
Another discussant, Mamas Mamas, MD, is involved with a 500-patient U.K. pandemic ACS registry nearing publication. The findings, he said, are similar to what Dr. Gershlick reported in terms of the high rate of presentation with cardiogenic shock and elevated in-hospital mortality. The COVID-positive ACS patients were also more likely to present with out-of-hospital cardiac arrest. But like Dr. Fuster, he is skeptical that their worse outcomes can be explained by a delay in seeking care.
“I don’t think the delay in presentation is really associated with the high mortality rate that we see. The delay in our U.K. registry is maybe half an hour for STEMIs and maybe 2-3 hours for NSTEMIs. And I don’t think that can produce a 30%-40% increase in mortality,” asserted Dr. Mamas, professor of cardiology at Keele University in Staffordshire, England.
Dr. Gershlick reported having no financial conflicts regarding his presentation.
FROM TCT 2020
Novel study explores link between primary immunodeficiencies, rheumatic diseases
Fully 48% of patients with autoimmune rheumatic diseases who developed persistent hypogammaglobulinemia after initiating treatment with immunomodulatory agents harbored gene variants associated with inborn errors of immunity, according to the findings of a single-center study published in Annals of the Rheumatic Diseases.
The results raise the possibility of a shared genetic etiology between “primary” and “secondary” hypogammaglobulinemia and suggest that some cases of autoimmune rheumatic disease may result from inborn errors of immunity. “In other words, a rheumatologist may be treating the rheumatic manifestations of a primary immunodeficiency disorder,” the study’s lead author, Georgios Sogkas, MD, PhD, said in an interview.
Experts now widely acknowledge an association between rheumatic diseases and inborn errors of immunity, or primary immunodeficiencies (PIDs). In one recent large retrospective study, 26% of patients with PIDs had at least one autoimmune or inflammatory disorder, and at least 13% of patients with PIDs had autoimmune rheumatic diseases. However, few studies have sought explanations for this link.
Only a minority of patients develop persistent hypogammaglobulinemia in response to immunomodulatory treatments for rheumatic diseases, suggesting a genetic basis for this outcome, according to Dr. Sogkas of the clinic for rheumatology and immunology at Hannover (Germany) Medical University. To explore this possibility, he and his associates measured the serum IgG levels of 1,008 Hannover University Hospital outpatients with autoimmune rheumatic diseases. In all, 64 patients had “persistent secondary hypogammaglobulinemia,” defined as at least a 12-month history of having serum IgG levels less than 7 g/L that began after the patients started on prednisolone or one or more synthetic or biologic disease-modifying antirheumatic drugs (DMARDs). Using next-generation sequencing (NGS), the researchers screened for known or candidate genes associated with primary antibody deficiencies by testing peripheral blood samples from this cohort and from 64 randomly selected patients with rheumatic diseases who did not have persistent hypogammaglobulinemia.
Among the patients with hypogammaglobulinemia, 31 (48%) had one or more potentially pathogenic variants (35 variants in total, all of them monoallelic). Notably, 10 patients (nearly 16%) harbored variants linked to autosomal dominant PIDs, and five patients harbored variants in NFKB1, which encodes the p51 subunit of the associated transcription factor. Among the 64 patients without hypogammaglobulinemia, only 7 (11%) harbored variants in the same PID-related genes, and only 1 had an autosomal dominant variant. This patient, who had a history of recurrent herpes infections, harbored a variant in the IRF2BP2 gene that does not necessarily lead to hypogammaglobulinemia, the researchers said.
‘Striking’ findings suggest a future in personalized medicine
Experts who were not involved in the study called the results noteworthy. “The fact that half of patients with rheumatic disease who developed secondary hypogammaglobulinemia were found to have a functionally relevant mutation in a known PID gene is striking, albeit purely circumstantial given the absence of any functional or mechanistic data,” said Michael J. Ombrello, MD, principal investigator and head of the translational genetics and genomics unit at the National Institute of Arthritis and Musculoskeletal and Skin Diseases, who was not involved in the study.
The findings, if they are validated by additional studies, might help clinicians personalize medicine by avoiding hypogammaglobulinemia-inducing immunomodulatory regimens in genetically predisposed patients, or by targeting Janus kinase (JAK) inhibitor therapy for patients with STAT3 gain-of-function variants, or PI3K delta inhibitors for patients with variants leading to hyperactivation of the PI3Kdelta gene, Dr. Sogkas said.
Dr. Ombrello agreed: “Whether the hypogammaglobulinemia is classified as primary or secondary, the presence of these genetic variants in half of patients with hypogammaglobulinemia suggests an opportunity to improve clinical care. Although far off at this point, one can imagine a day where genetic data allows a rheumatologist to identify new-onset rheumatic disease patients carrying PID gene mutations and cater their therapy and monitoring accordingly.”
If further research validates these findings, they would add to a growing body of support for incorporating expanded or universal exome or genome sequencing in the care of medically complex patients, such as those with rheumatic diseases, Dr. Ombrello said. However, he cautioned that the investigators could have “overstated” the relationship in their study between secondary hypogammaglobulinemia and immunomodulatory treatment. The fact that a small group of study participants (about 7%) developed hypogammaglobulinemia after initiating immunomodulatory therapy does not confirm a causal relationship, he emphasized. Common variable immune deficiency (CVID) can develop in adults as late as the fifth and sixth decade of life, he noted, making it “not implausible that a small number of rheumatic disease patients would develop CVID while under the care of a rheumatologist. Would these patients have developed hypogammaglobulinemia even without treatment with immunomodulators, purely related to their genetic mutations? If so, they would be better classified as having primary immune deficiency, although that distinction is largely one of semantics.”
‘Rheumatologists are obliged to step up’
Interestingly, only 23% of the patients with hypogammaglobulinemia in the study had a clinically significant history of infections even though only 9% were receiving prophylactic antibiotics. Such findings highlight the complexity of PIDs, according to experts. “A long generation ago, we thought of immunodeficiencies as infections. Now we see them as autoimmune diseases, inflammatory diseases, allergic diseases – the spectrum continues to enlarge,” said Leonard H. Calabrese, DO, the RJ Fasenmyer chair of clinical immunology at the Cleveland Clinic, who was not involved in the study.
Dr. Calabrese noted that more than 450 monogenic variants have been linked to inborn errors of immunity. “Because these [PIDs] can mimic autoinflammatory presentations, rheumatologists are obliged to step up and gain a greater understanding, to be able to recognize and diagnose them and sort them out.”
Future goals should include quantifying the prevalence of genetic variants underlying hypogammaglobulinemia among patients with rheumatic diseases, and better characterizing outcomes and phenotypes of patients harboring variants linked to inborn errors of immunity, Dr. Sogkas said. “Whether these patients actually have a different disease than what they are being treated for, I can’t tell from this paper, and that’s an important question for the future,” added Dr. Calabrese. “I also do wonder about the effects of different drugs,” he said, noting that many patients with PID-associated autosomal gene variants developed persistent secondary hypogammaglobulinemia after initiating methotrexate. “It makes me wonder whether some of these genes have a specific interaction with methotrexate,” he said. “That could be a biomarker for drug toxicity.”
Study funders included the German Research Foundation, the German multiorgan Autoimmunity Network, Hannover Medical School, the Rosemarie-Germscheid Foundation, the German Academic Exchange Service, HBRS, the Center for Infection Biology, and the German Center for Infection Research. The investigators reported having no competing interests.
SOURCE: Sogkas G et al. Ann Rheum Dis. 2020 Oct 12. doi: 10.1136/annrheumdis-2020-218280.
Fully 48% of patients with autoimmune rheumatic diseases who developed persistent hypogammaglobulinemia after initiating treatment with immunomodulatory agents harbored gene variants associated with inborn errors of immunity, according to the findings of a single-center study published in Annals of the Rheumatic Diseases.
The results raise the possibility of a shared genetic etiology between “primary” and “secondary” hypogammaglobulinemia and suggest that some cases of autoimmune rheumatic disease may result from inborn errors of immunity. “In other words, a rheumatologist may be treating the rheumatic manifestations of a primary immunodeficiency disorder,” the study’s lead author, Georgios Sogkas, MD, PhD, said in an interview.
Experts now widely acknowledge an association between rheumatic diseases and inborn errors of immunity, or primary immunodeficiencies (PIDs). In one recent large retrospective study, 26% of patients with PIDs had at least one autoimmune or inflammatory disorder, and at least 13% of patients with PIDs had autoimmune rheumatic diseases. However, few studies have sought explanations for this link.
Only a minority of patients develop persistent hypogammaglobulinemia in response to immunomodulatory treatments for rheumatic diseases, suggesting a genetic basis for this outcome, according to Dr. Sogkas of the clinic for rheumatology and immunology at Hannover (Germany) Medical University. To explore this possibility, he and his associates measured the serum IgG levels of 1,008 Hannover University Hospital outpatients with autoimmune rheumatic diseases. In all, 64 patients had “persistent secondary hypogammaglobulinemia,” defined as at least a 12-month history of having serum IgG levels less than 7 g/L that began after the patients started on prednisolone or one or more synthetic or biologic disease-modifying antirheumatic drugs (DMARDs). Using next-generation sequencing (NGS), the researchers screened for known or candidate genes associated with primary antibody deficiencies by testing peripheral blood samples from this cohort and from 64 randomly selected patients with rheumatic diseases who did not have persistent hypogammaglobulinemia.
Among the patients with hypogammaglobulinemia, 31 (48%) had one or more potentially pathogenic variants (35 variants in total, all of them monoallelic). Notably, 10 patients (nearly 16%) harbored variants linked to autosomal dominant PIDs, and five patients harbored variants in NFKB1, which encodes the p51 subunit of the associated transcription factor. Among the 64 patients without hypogammaglobulinemia, only 7 (11%) harbored variants in the same PID-related genes, and only 1 had an autosomal dominant variant. This patient, who had a history of recurrent herpes infections, harbored a variant in the IRF2BP2 gene that does not necessarily lead to hypogammaglobulinemia, the researchers said.
‘Striking’ findings suggest a future in personalized medicine
Experts who were not involved in the study called the results noteworthy. “The fact that half of patients with rheumatic disease who developed secondary hypogammaglobulinemia were found to have a functionally relevant mutation in a known PID gene is striking, albeit purely circumstantial given the absence of any functional or mechanistic data,” said Michael J. Ombrello, MD, principal investigator and head of the translational genetics and genomics unit at the National Institute of Arthritis and Musculoskeletal and Skin Diseases, who was not involved in the study.
The findings, if they are validated by additional studies, might help clinicians personalize medicine by avoiding hypogammaglobulinemia-inducing immunomodulatory regimens in genetically predisposed patients, or by targeting Janus kinase (JAK) inhibitor therapy for patients with STAT3 gain-of-function variants, or PI3K delta inhibitors for patients with variants leading to hyperactivation of the PI3Kdelta gene, Dr. Sogkas said.
Dr. Ombrello agreed: “Whether the hypogammaglobulinemia is classified as primary or secondary, the presence of these genetic variants in half of patients with hypogammaglobulinemia suggests an opportunity to improve clinical care. Although far off at this point, one can imagine a day where genetic data allows a rheumatologist to identify new-onset rheumatic disease patients carrying PID gene mutations and cater their therapy and monitoring accordingly.”
If further research validates these findings, they would add to a growing body of support for incorporating expanded or universal exome or genome sequencing in the care of medically complex patients, such as those with rheumatic diseases, Dr. Ombrello said. However, he cautioned that the investigators could have “overstated” the relationship in their study between secondary hypogammaglobulinemia and immunomodulatory treatment. The fact that a small group of study participants (about 7%) developed hypogammaglobulinemia after initiating immunomodulatory therapy does not confirm a causal relationship, he emphasized. Common variable immune deficiency (CVID) can develop in adults as late as the fifth and sixth decade of life, he noted, making it “not implausible that a small number of rheumatic disease patients would develop CVID while under the care of a rheumatologist. Would these patients have developed hypogammaglobulinemia even without treatment with immunomodulators, purely related to their genetic mutations? If so, they would be better classified as having primary immune deficiency, although that distinction is largely one of semantics.”
‘Rheumatologists are obliged to step up’
Interestingly, only 23% of the patients with hypogammaglobulinemia in the study had a clinically significant history of infections even though only 9% were receiving prophylactic antibiotics. Such findings highlight the complexity of PIDs, according to experts. “A long generation ago, we thought of immunodeficiencies as infections. Now we see them as autoimmune diseases, inflammatory diseases, allergic diseases – the spectrum continues to enlarge,” said Leonard H. Calabrese, DO, the RJ Fasenmyer chair of clinical immunology at the Cleveland Clinic, who was not involved in the study.
Dr. Calabrese noted that more than 450 monogenic variants have been linked to inborn errors of immunity. “Because these [PIDs] can mimic autoinflammatory presentations, rheumatologists are obliged to step up and gain a greater understanding, to be able to recognize and diagnose them and sort them out.”
Future goals should include quantifying the prevalence of genetic variants underlying hypogammaglobulinemia among patients with rheumatic diseases, and better characterizing outcomes and phenotypes of patients harboring variants linked to inborn errors of immunity, Dr. Sogkas said. “Whether these patients actually have a different disease than what they are being treated for, I can’t tell from this paper, and that’s an important question for the future,” added Dr. Calabrese. “I also do wonder about the effects of different drugs,” he said, noting that many patients with PID-associated autosomal gene variants developed persistent secondary hypogammaglobulinemia after initiating methotrexate. “It makes me wonder whether some of these genes have a specific interaction with methotrexate,” he said. “That could be a biomarker for drug toxicity.”
Study funders included the German Research Foundation, the German multiorgan Autoimmunity Network, Hannover Medical School, the Rosemarie-Germscheid Foundation, the German Academic Exchange Service, HBRS, the Center for Infection Biology, and the German Center for Infection Research. The investigators reported having no competing interests.
SOURCE: Sogkas G et al. Ann Rheum Dis. 2020 Oct 12. doi: 10.1136/annrheumdis-2020-218280.
Fully 48% of patients with autoimmune rheumatic diseases who developed persistent hypogammaglobulinemia after initiating treatment with immunomodulatory agents harbored gene variants associated with inborn errors of immunity, according to the findings of a single-center study published in Annals of the Rheumatic Diseases.
The results raise the possibility of a shared genetic etiology between “primary” and “secondary” hypogammaglobulinemia and suggest that some cases of autoimmune rheumatic disease may result from inborn errors of immunity. “In other words, a rheumatologist may be treating the rheumatic manifestations of a primary immunodeficiency disorder,” the study’s lead author, Georgios Sogkas, MD, PhD, said in an interview.
Experts now widely acknowledge an association between rheumatic diseases and inborn errors of immunity, or primary immunodeficiencies (PIDs). In one recent large retrospective study, 26% of patients with PIDs had at least one autoimmune or inflammatory disorder, and at least 13% of patients with PIDs had autoimmune rheumatic diseases. However, few studies have sought explanations for this link.
Only a minority of patients develop persistent hypogammaglobulinemia in response to immunomodulatory treatments for rheumatic diseases, suggesting a genetic basis for this outcome, according to Dr. Sogkas of the clinic for rheumatology and immunology at Hannover (Germany) Medical University. To explore this possibility, he and his associates measured the serum IgG levels of 1,008 Hannover University Hospital outpatients with autoimmune rheumatic diseases. In all, 64 patients had “persistent secondary hypogammaglobulinemia,” defined as at least a 12-month history of having serum IgG levels less than 7 g/L that began after the patients started on prednisolone or one or more synthetic or biologic disease-modifying antirheumatic drugs (DMARDs). Using next-generation sequencing (NGS), the researchers screened for known or candidate genes associated with primary antibody deficiencies by testing peripheral blood samples from this cohort and from 64 randomly selected patients with rheumatic diseases who did not have persistent hypogammaglobulinemia.
Among the patients with hypogammaglobulinemia, 31 (48%) had one or more potentially pathogenic variants (35 variants in total, all of them monoallelic). Notably, 10 patients (nearly 16%) harbored variants linked to autosomal dominant PIDs, and five patients harbored variants in NFKB1, which encodes the p51 subunit of the associated transcription factor. Among the 64 patients without hypogammaglobulinemia, only 7 (11%) harbored variants in the same PID-related genes, and only 1 had an autosomal dominant variant. This patient, who had a history of recurrent herpes infections, harbored a variant in the IRF2BP2 gene that does not necessarily lead to hypogammaglobulinemia, the researchers said.
‘Striking’ findings suggest a future in personalized medicine
Experts who were not involved in the study called the results noteworthy. “The fact that half of patients with rheumatic disease who developed secondary hypogammaglobulinemia were found to have a functionally relevant mutation in a known PID gene is striking, albeit purely circumstantial given the absence of any functional or mechanistic data,” said Michael J. Ombrello, MD, principal investigator and head of the translational genetics and genomics unit at the National Institute of Arthritis and Musculoskeletal and Skin Diseases, who was not involved in the study.
The findings, if they are validated by additional studies, might help clinicians personalize medicine by avoiding hypogammaglobulinemia-inducing immunomodulatory regimens in genetically predisposed patients, or by targeting Janus kinase (JAK) inhibitor therapy for patients with STAT3 gain-of-function variants, or PI3K delta inhibitors for patients with variants leading to hyperactivation of the PI3Kdelta gene, Dr. Sogkas said.
Dr. Ombrello agreed: “Whether the hypogammaglobulinemia is classified as primary or secondary, the presence of these genetic variants in half of patients with hypogammaglobulinemia suggests an opportunity to improve clinical care. Although far off at this point, one can imagine a day where genetic data allows a rheumatologist to identify new-onset rheumatic disease patients carrying PID gene mutations and cater their therapy and monitoring accordingly.”
If further research validates these findings, they would add to a growing body of support for incorporating expanded or universal exome or genome sequencing in the care of medically complex patients, such as those with rheumatic diseases, Dr. Ombrello said. However, he cautioned that the investigators could have “overstated” the relationship in their study between secondary hypogammaglobulinemia and immunomodulatory treatment. The fact that a small group of study participants (about 7%) developed hypogammaglobulinemia after initiating immunomodulatory therapy does not confirm a causal relationship, he emphasized. Common variable immune deficiency (CVID) can develop in adults as late as the fifth and sixth decade of life, he noted, making it “not implausible that a small number of rheumatic disease patients would develop CVID while under the care of a rheumatologist. Would these patients have developed hypogammaglobulinemia even without treatment with immunomodulators, purely related to their genetic mutations? If so, they would be better classified as having primary immune deficiency, although that distinction is largely one of semantics.”
‘Rheumatologists are obliged to step up’
Interestingly, only 23% of the patients with hypogammaglobulinemia in the study had a clinically significant history of infections even though only 9% were receiving prophylactic antibiotics. Such findings highlight the complexity of PIDs, according to experts. “A long generation ago, we thought of immunodeficiencies as infections. Now we see them as autoimmune diseases, inflammatory diseases, allergic diseases – the spectrum continues to enlarge,” said Leonard H. Calabrese, DO, the RJ Fasenmyer chair of clinical immunology at the Cleveland Clinic, who was not involved in the study.
Dr. Calabrese noted that more than 450 monogenic variants have been linked to inborn errors of immunity. “Because these [PIDs] can mimic autoinflammatory presentations, rheumatologists are obliged to step up and gain a greater understanding, to be able to recognize and diagnose them and sort them out.”
Future goals should include quantifying the prevalence of genetic variants underlying hypogammaglobulinemia among patients with rheumatic diseases, and better characterizing outcomes and phenotypes of patients harboring variants linked to inborn errors of immunity, Dr. Sogkas said. “Whether these patients actually have a different disease than what they are being treated for, I can’t tell from this paper, and that’s an important question for the future,” added Dr. Calabrese. “I also do wonder about the effects of different drugs,” he said, noting that many patients with PID-associated autosomal gene variants developed persistent secondary hypogammaglobulinemia after initiating methotrexate. “It makes me wonder whether some of these genes have a specific interaction with methotrexate,” he said. “That could be a biomarker for drug toxicity.”
Study funders included the German Research Foundation, the German multiorgan Autoimmunity Network, Hannover Medical School, the Rosemarie-Germscheid Foundation, the German Academic Exchange Service, HBRS, the Center for Infection Biology, and the German Center for Infection Research. The investigators reported having no competing interests.
SOURCE: Sogkas G et al. Ann Rheum Dis. 2020 Oct 12. doi: 10.1136/annrheumdis-2020-218280.
FROM ANNALS OF THE RHEUMATIC DISEASES
Selexipag has no effect on daily activity in PAH patients
Selexipag (Uptravi) does not change the level of daily activity of patients with pulmonary arterial hypertension (PAH), results from the phase 4 TRACE trial suggest.
“We had no preconceived idea if this drug would improve exercise capacity,” said Luke Howard, MD, of Imperial College Healthcare NHS Trust in London. It was clear, however, that 6-minute walk tests conducted a few times a year “don’t paint a picture of what daily life is like for patients on selexipag.”
The oral prostacyclin IP receptor agonist is prescribed to slow the progression of PAH and reduce hospital admissions, but there are no studies that show whether it improves quality of life.
Dr. Howard and his team turned to wearable technology to “capture a snapshot of everyday life,” he explained during his presentation at the annual meeting of the American College of Chest Physicians (CHEST 2020), held virtually this year.
The primary concern of the investigators was to get TRACE participants – all with PAH – to wear a wrist device; they did not encourage patients to become more active. “We wanted a true picture of the impact of the drug itself,” he noted.
After 24 months of daily tracking, “there was no benefit to increased daily activity for patients taking this drug,” Dr. Howard said in an interview. “That was a bit deflating.”
The daily activity of TRACE participants was “slightly more elevated” in the selexipag group than in the placebo group. “We saw some numerical drops in activity in the placebo group, and a trend that might make a difference over a longer, bigger study, but not in a statically significant way,” he reported.
In the randomized, blinded trial – the first to track the activity of PAH patients – 53 participants received selexipag and 55 received placebo. All 108 wore a wrist accelerometer (GT9X Link) that counted the number of steps taken each day, providing an indication of daily activity.
Device compliance – the mean number of days in which the device was worn for at least 7 hours during a 14-day predrug period – was similar in the selexipag and placebo groups (13.2 vs 13.0 days).
“We wanted to make sure we had people who were stable and weren’t enrolled in a rehabilitation program; we didn’t want any competing influences,” Dr. Howard explained. All in all, the participants were in pretty good shape. “There was a low risk of a bad outcome.”
The primary endpoint was change in activity from baseline to week 24. The secondary endpoints were PAH-SYMPACT health quality-of-life tests and 6-minute walk distance.
Similar activity levels in both groups
As expected in a population in which the majority of patients meet the criteria for WHO functional class II PAH, all participants had low PAH-SYMPACT domain scores throughout the trial.
All adverse events were “consistent with the known profile” of selexipag, and there were no deaths, Dr. Howard reported.
“We did not show any significant benefit to taking the drug,” he said, but the drug is marketed for the prevention of disease progression, and this finding “doesn’t change that.”
Pulmonary rehabilitation
“Pulmonary rehabilitation is one of the most vital management issues with chronic lung disease,” Riddhi Upadhyay, MD, of Carle Foundation Hospital in Urbana, Ill., said during her CHEST 2020 presentation on improving PAH rehabilitation referral rates.
“We know it improves exercise capacity, lung function, and decreases total hospital stays and recurrent hospital admission,” she explained. And studies have shown that PAH rehabilitation “also reduces frailty and improves quality of life.”
In their study, Dr. Upadhyay and colleagues showed that when pulmonary rehabilitation is added to the discharge order set, referrals increase by 60%.
They attribute their success to “recognizing the benefits of pulmonary rehab and understanding where interventions are required.”
An encouraging takeaway from the TRACE data is that it established that daily activity can be tracked in this patient population. “We think we might need to encourage these patients to get active, maybe combine the drug with a formal rehabilitation program; that might increase motivation,” Dr. Howard said.
“People don’t necessarily do more just because they can,” he noted.
Dr. Howard has received consulting fees from Actelion.
A version of this article originally appeared on Medscape.com.
Selexipag (Uptravi) does not change the level of daily activity of patients with pulmonary arterial hypertension (PAH), results from the phase 4 TRACE trial suggest.
“We had no preconceived idea if this drug would improve exercise capacity,” said Luke Howard, MD, of Imperial College Healthcare NHS Trust in London. It was clear, however, that 6-minute walk tests conducted a few times a year “don’t paint a picture of what daily life is like for patients on selexipag.”
The oral prostacyclin IP receptor agonist is prescribed to slow the progression of PAH and reduce hospital admissions, but there are no studies that show whether it improves quality of life.
Dr. Howard and his team turned to wearable technology to “capture a snapshot of everyday life,” he explained during his presentation at the annual meeting of the American College of Chest Physicians (CHEST 2020), held virtually this year.
The primary concern of the investigators was to get TRACE participants – all with PAH – to wear a wrist device; they did not encourage patients to become more active. “We wanted a true picture of the impact of the drug itself,” he noted.
After 24 months of daily tracking, “there was no benefit to increased daily activity for patients taking this drug,” Dr. Howard said in an interview. “That was a bit deflating.”
The daily activity of TRACE participants was “slightly more elevated” in the selexipag group than in the placebo group. “We saw some numerical drops in activity in the placebo group, and a trend that might make a difference over a longer, bigger study, but not in a statically significant way,” he reported.
In the randomized, blinded trial – the first to track the activity of PAH patients – 53 participants received selexipag and 55 received placebo. All 108 wore a wrist accelerometer (GT9X Link) that counted the number of steps taken each day, providing an indication of daily activity.
Device compliance – the mean number of days in which the device was worn for at least 7 hours during a 14-day predrug period – was similar in the selexipag and placebo groups (13.2 vs 13.0 days).
“We wanted to make sure we had people who were stable and weren’t enrolled in a rehabilitation program; we didn’t want any competing influences,” Dr. Howard explained. All in all, the participants were in pretty good shape. “There was a low risk of a bad outcome.”
The primary endpoint was change in activity from baseline to week 24. The secondary endpoints were PAH-SYMPACT health quality-of-life tests and 6-minute walk distance.
Similar activity levels in both groups
As expected in a population in which the majority of patients meet the criteria for WHO functional class II PAH, all participants had low PAH-SYMPACT domain scores throughout the trial.
All adverse events were “consistent with the known profile” of selexipag, and there were no deaths, Dr. Howard reported.
“We did not show any significant benefit to taking the drug,” he said, but the drug is marketed for the prevention of disease progression, and this finding “doesn’t change that.”
Pulmonary rehabilitation
“Pulmonary rehabilitation is one of the most vital management issues with chronic lung disease,” Riddhi Upadhyay, MD, of Carle Foundation Hospital in Urbana, Ill., said during her CHEST 2020 presentation on improving PAH rehabilitation referral rates.
“We know it improves exercise capacity, lung function, and decreases total hospital stays and recurrent hospital admission,” she explained. And studies have shown that PAH rehabilitation “also reduces frailty and improves quality of life.”
In their study, Dr. Upadhyay and colleagues showed that when pulmonary rehabilitation is added to the discharge order set, referrals increase by 60%.
They attribute their success to “recognizing the benefits of pulmonary rehab and understanding where interventions are required.”
An encouraging takeaway from the TRACE data is that it established that daily activity can be tracked in this patient population. “We think we might need to encourage these patients to get active, maybe combine the drug with a formal rehabilitation program; that might increase motivation,” Dr. Howard said.
“People don’t necessarily do more just because they can,” he noted.
Dr. Howard has received consulting fees from Actelion.
A version of this article originally appeared on Medscape.com.
Selexipag (Uptravi) does not change the level of daily activity of patients with pulmonary arterial hypertension (PAH), results from the phase 4 TRACE trial suggest.
“We had no preconceived idea if this drug would improve exercise capacity,” said Luke Howard, MD, of Imperial College Healthcare NHS Trust in London. It was clear, however, that 6-minute walk tests conducted a few times a year “don’t paint a picture of what daily life is like for patients on selexipag.”
The oral prostacyclin IP receptor agonist is prescribed to slow the progression of PAH and reduce hospital admissions, but there are no studies that show whether it improves quality of life.
Dr. Howard and his team turned to wearable technology to “capture a snapshot of everyday life,” he explained during his presentation at the annual meeting of the American College of Chest Physicians (CHEST 2020), held virtually this year.
The primary concern of the investigators was to get TRACE participants – all with PAH – to wear a wrist device; they did not encourage patients to become more active. “We wanted a true picture of the impact of the drug itself,” he noted.
After 24 months of daily tracking, “there was no benefit to increased daily activity for patients taking this drug,” Dr. Howard said in an interview. “That was a bit deflating.”
The daily activity of TRACE participants was “slightly more elevated” in the selexipag group than in the placebo group. “We saw some numerical drops in activity in the placebo group, and a trend that might make a difference over a longer, bigger study, but not in a statically significant way,” he reported.
In the randomized, blinded trial – the first to track the activity of PAH patients – 53 participants received selexipag and 55 received placebo. All 108 wore a wrist accelerometer (GT9X Link) that counted the number of steps taken each day, providing an indication of daily activity.
Device compliance – the mean number of days in which the device was worn for at least 7 hours during a 14-day predrug period – was similar in the selexipag and placebo groups (13.2 vs 13.0 days).
“We wanted to make sure we had people who were stable and weren’t enrolled in a rehabilitation program; we didn’t want any competing influences,” Dr. Howard explained. All in all, the participants were in pretty good shape. “There was a low risk of a bad outcome.”
The primary endpoint was change in activity from baseline to week 24. The secondary endpoints were PAH-SYMPACT health quality-of-life tests and 6-minute walk distance.
Similar activity levels in both groups
As expected in a population in which the majority of patients meet the criteria for WHO functional class II PAH, all participants had low PAH-SYMPACT domain scores throughout the trial.
All adverse events were “consistent with the known profile” of selexipag, and there were no deaths, Dr. Howard reported.
“We did not show any significant benefit to taking the drug,” he said, but the drug is marketed for the prevention of disease progression, and this finding “doesn’t change that.”
Pulmonary rehabilitation
“Pulmonary rehabilitation is one of the most vital management issues with chronic lung disease,” Riddhi Upadhyay, MD, of Carle Foundation Hospital in Urbana, Ill., said during her CHEST 2020 presentation on improving PAH rehabilitation referral rates.
“We know it improves exercise capacity, lung function, and decreases total hospital stays and recurrent hospital admission,” she explained. And studies have shown that PAH rehabilitation “also reduces frailty and improves quality of life.”
In their study, Dr. Upadhyay and colleagues showed that when pulmonary rehabilitation is added to the discharge order set, referrals increase by 60%.
They attribute their success to “recognizing the benefits of pulmonary rehab and understanding where interventions are required.”
An encouraging takeaway from the TRACE data is that it established that daily activity can be tracked in this patient population. “We think we might need to encourage these patients to get active, maybe combine the drug with a formal rehabilitation program; that might increase motivation,” Dr. Howard said.
“People don’t necessarily do more just because they can,” he noted.
Dr. Howard has received consulting fees from Actelion.
A version of this article originally appeared on Medscape.com.
Brazil confirms death of volunteer in COVID-19 vaccine trial
The Brazilian National Health Surveillance Agency (Anvisa) announced Oct. 21 that it is investigating data received on the death of a volunteer in a clinical trial of the COVID-19 vaccine developed by Oxford University and the pharmaceutical company AstraZeneca.
In an email sent to Medscape Medical News, the agency states that it was formally informed of the death on October 19. It has already received data regarding the investigation of the case, which is now being conducted by the Brazilian International Security Assessment Committee.
The identity of the volunteer and cause of death have not yet been confirmed by any official source linked to the study. In the email, Anvisa reiterated that “according to national and international regulations on good clinical practices, data on clinical research volunteers must be kept confidential, in accordance with the principles of confidentiality, human dignity, and protection of participants.”
A report in the Brazilian newspaper O Globo, however, states that the patient who died is a 28-year-old doctor, recently graduated, who worked on the front line of combating COVID-19 in three hospitals in Rio de Janeiro. . Due to the study design, it is impossible to know whether the volunteer received the vaccine or placebo.
It is imperative to wait for the results of the investigations, said Sergio Cimerman, MD, the scientific coordinator of the Brazilian Society of Infectious Diseases (SBI), because death is possible during any vaccine trial, even more so in cases in which the final goal is to immunize the population in record time.
“It is precisely the phase 3 study that assesses efficacy and safety so that the vaccine can be used for the entire population. We cannot let ourselves lose hope, and we must move forward, as safely as possible, in search of an ideal vaccine,” said Cimerman, who works at the Instituto de Infectologia Emílio Ribas and is also an advisor to the Portuguese edition of Medscape.
This article was translated and adapted from the Portuguese edition of Medscape.
The Brazilian National Health Surveillance Agency (Anvisa) announced Oct. 21 that it is investigating data received on the death of a volunteer in a clinical trial of the COVID-19 vaccine developed by Oxford University and the pharmaceutical company AstraZeneca.
In an email sent to Medscape Medical News, the agency states that it was formally informed of the death on October 19. It has already received data regarding the investigation of the case, which is now being conducted by the Brazilian International Security Assessment Committee.
The identity of the volunteer and cause of death have not yet been confirmed by any official source linked to the study. In the email, Anvisa reiterated that “according to national and international regulations on good clinical practices, data on clinical research volunteers must be kept confidential, in accordance with the principles of confidentiality, human dignity, and protection of participants.”
A report in the Brazilian newspaper O Globo, however, states that the patient who died is a 28-year-old doctor, recently graduated, who worked on the front line of combating COVID-19 in three hospitals in Rio de Janeiro. . Due to the study design, it is impossible to know whether the volunteer received the vaccine or placebo.
It is imperative to wait for the results of the investigations, said Sergio Cimerman, MD, the scientific coordinator of the Brazilian Society of Infectious Diseases (SBI), because death is possible during any vaccine trial, even more so in cases in which the final goal is to immunize the population in record time.
“It is precisely the phase 3 study that assesses efficacy and safety so that the vaccine can be used for the entire population. We cannot let ourselves lose hope, and we must move forward, as safely as possible, in search of an ideal vaccine,” said Cimerman, who works at the Instituto de Infectologia Emílio Ribas and is also an advisor to the Portuguese edition of Medscape.
This article was translated and adapted from the Portuguese edition of Medscape.
The Brazilian National Health Surveillance Agency (Anvisa) announced Oct. 21 that it is investigating data received on the death of a volunteer in a clinical trial of the COVID-19 vaccine developed by Oxford University and the pharmaceutical company AstraZeneca.
In an email sent to Medscape Medical News, the agency states that it was formally informed of the death on October 19. It has already received data regarding the investigation of the case, which is now being conducted by the Brazilian International Security Assessment Committee.
The identity of the volunteer and cause of death have not yet been confirmed by any official source linked to the study. In the email, Anvisa reiterated that “according to national and international regulations on good clinical practices, data on clinical research volunteers must be kept confidential, in accordance with the principles of confidentiality, human dignity, and protection of participants.”
A report in the Brazilian newspaper O Globo, however, states that the patient who died is a 28-year-old doctor, recently graduated, who worked on the front line of combating COVID-19 in three hospitals in Rio de Janeiro. . Due to the study design, it is impossible to know whether the volunteer received the vaccine or placebo.
It is imperative to wait for the results of the investigations, said Sergio Cimerman, MD, the scientific coordinator of the Brazilian Society of Infectious Diseases (SBI), because death is possible during any vaccine trial, even more so in cases in which the final goal is to immunize the population in record time.
“It is precisely the phase 3 study that assesses efficacy and safety so that the vaccine can be used for the entire population. We cannot let ourselves lose hope, and we must move forward, as safely as possible, in search of an ideal vaccine,” said Cimerman, who works at the Instituto de Infectologia Emílio Ribas and is also an advisor to the Portuguese edition of Medscape.
This article was translated and adapted from the Portuguese edition of Medscape.
COVID-19 experience forced residents to quickly improve patient communication skills
While the spring peak of COVID-19 was tough and traumatic for many residents and interns in a New York City health system, the experience may have accelerated their patient communication skills regarding difficult goals-of-care discussions, results of a recent survey suggest.
Breaking bad news was an everyday or every-other-day occurrence at the peak of the pandemic for nearly all of 50 of the trainees surveyed, who had worked at hospitals affiliated with the internal medicine residency program at the at the Icahn School of Medicine at Mount Sinai from March to June 2020.
However, trainees became significantly more comfortable and fluent in goals-of-care discussions during the pandemic, according to Patrick Tobin-Schnittger, MBBS, a third-year internal medicine resident in the Mount Sinai program.
“COVID-19 has obviously made a huge impact on the world, but I think it’s also made a huge impact on a whole generation of junior doctors,” said Dr. Tobin-Schnittger, who presented the findings in a late-breaking abstract session at the CHEST Annual Meeting, held virtually this year.
“It’ll be interesting to see what happens in the future as that generation matures, and I think one of the things is that we’re a lot more comfortable with end-of-life care,” he said in an interview conducted during the conference.
Nevertheless, coping with death may still be a challenge for many residents, according to Dr. Tobin-Schnittger. In the survey, internal medicine residents who had rarely encountered patient deaths suddenly found themselves experiencing deaths weekly, with more than one in five saying they were encountering it every day.
When asked to self-rate themselves according to Bugen’s Coping With Death scale, most participants had scores that suggested their ability to cope was suboptimal, the researcher said.
To help trainees cope with local COVID-19 surges, internal medicine residency programs should be implementing “breaking bad news” workshops and educating house staff on resilience in times of crisis, especially if it can be done virtually, according to Dr. Tobin-Schnittger.
“That could be done pretty quickly, and it could be done remotely so people could practice this from home,” he explained. “They wouldn’t even need to congregate in a big room.”
As a “mini-surge” of COVID-19 cases hits the United States, teaching self-care and coping techniques may also be important, said Mangala Narasimhan, DO, FCCP, director of critical care services at Northwell Health in New York City.
“We’ve had several sessions in our health system of letting people vent, talk about what happened, and tell stories about patients that they are still thinking about and haunted by – there was so much death,” Dr. Narasimhan said in an interview.
“People will be suffering for a long time thinking about what happened in March and April and May, so I think our focus now needs to be how to fix that in any way we can and to support people, as we’re dealing with these increases in numbers,” she said. “I think everyone’s panicking over the increase in numbers, but they’re panicking because of the fear of going through what they went through before.”
Dr. Tobin-Schnittger and colleagues sent their survey to 94 residents and interns in the Mount Sinai program who had worked through the peak of the pandemic. They received 50 responses. Of those individuals, the mean age was 29.5 years, and about 46% had worked for more than 3 years.
Before the pandemic, only 3 of the 50 respondents reported having goals-of-care conversations every day or every other day, while during the pandemic, those conversations were happening at least every other day for 38 of the respondents, survey data show.
Self-reported fluency and comfort with those discussions increased significantly, from a mean of about 50 on a scale of 100 before the pandemic to more than 75 during the pandemic, according to Dr. Tobin-Schnittger.
When asked how they remembered coping with patient death, one respondent described holding up a phone so a dying patient could hear his daughter’s voice. Another reported not being able to sleep at night.
“I constantly would have dreams that my patients were dying and there was nothing I could do about it,” the respondent said in a survey response.
A third respondent described the experience as ”humbling” but said there were rewarding aspects in patient care during the peak of the pandemic, which helped in being able to focus during difficult days.
Three participants (7.7%) said they changed their career plans as a result of the pandemic experience, the researchers reported.
Negative consequences of the peak pandemic experience included anger, anxiety, professional strain, trauma, and emotional distancing, some respondents reported.
However, others called attention to positive outcomes, such as more professional pride, resilience, confidence, and camaraderie.
“While we did encounter a lot of traumatic experiences, overall, there’s a huge sense that there is a lot more camaraderie within our department, but also within other departments,” said Dr. Tobin-Schnittger. “So I think there are some positives that come from this, and I think there’s been a bit of a culture change.”
Dr. Tobin-Schnittger said that he and his coauthors had no conflicts of interest or relationships with commercial interests to report.
SOURCE: Tobin-Schnittger P. CHEST 2020. Late-breaking abstract. doi: 10.1016/j.chest.2020.09.040.
While the spring peak of COVID-19 was tough and traumatic for many residents and interns in a New York City health system, the experience may have accelerated their patient communication skills regarding difficult goals-of-care discussions, results of a recent survey suggest.
Breaking bad news was an everyday or every-other-day occurrence at the peak of the pandemic for nearly all of 50 of the trainees surveyed, who had worked at hospitals affiliated with the internal medicine residency program at the at the Icahn School of Medicine at Mount Sinai from March to June 2020.
However, trainees became significantly more comfortable and fluent in goals-of-care discussions during the pandemic, according to Patrick Tobin-Schnittger, MBBS, a third-year internal medicine resident in the Mount Sinai program.
“COVID-19 has obviously made a huge impact on the world, but I think it’s also made a huge impact on a whole generation of junior doctors,” said Dr. Tobin-Schnittger, who presented the findings in a late-breaking abstract session at the CHEST Annual Meeting, held virtually this year.
“It’ll be interesting to see what happens in the future as that generation matures, and I think one of the things is that we’re a lot more comfortable with end-of-life care,” he said in an interview conducted during the conference.
Nevertheless, coping with death may still be a challenge for many residents, according to Dr. Tobin-Schnittger. In the survey, internal medicine residents who had rarely encountered patient deaths suddenly found themselves experiencing deaths weekly, with more than one in five saying they were encountering it every day.
When asked to self-rate themselves according to Bugen’s Coping With Death scale, most participants had scores that suggested their ability to cope was suboptimal, the researcher said.
To help trainees cope with local COVID-19 surges, internal medicine residency programs should be implementing “breaking bad news” workshops and educating house staff on resilience in times of crisis, especially if it can be done virtually, according to Dr. Tobin-Schnittger.
“That could be done pretty quickly, and it could be done remotely so people could practice this from home,” he explained. “They wouldn’t even need to congregate in a big room.”
As a “mini-surge” of COVID-19 cases hits the United States, teaching self-care and coping techniques may also be important, said Mangala Narasimhan, DO, FCCP, director of critical care services at Northwell Health in New York City.
“We’ve had several sessions in our health system of letting people vent, talk about what happened, and tell stories about patients that they are still thinking about and haunted by – there was so much death,” Dr. Narasimhan said in an interview.
“People will be suffering for a long time thinking about what happened in March and April and May, so I think our focus now needs to be how to fix that in any way we can and to support people, as we’re dealing with these increases in numbers,” she said. “I think everyone’s panicking over the increase in numbers, but they’re panicking because of the fear of going through what they went through before.”
Dr. Tobin-Schnittger and colleagues sent their survey to 94 residents and interns in the Mount Sinai program who had worked through the peak of the pandemic. They received 50 responses. Of those individuals, the mean age was 29.5 years, and about 46% had worked for more than 3 years.
Before the pandemic, only 3 of the 50 respondents reported having goals-of-care conversations every day or every other day, while during the pandemic, those conversations were happening at least every other day for 38 of the respondents, survey data show.
Self-reported fluency and comfort with those discussions increased significantly, from a mean of about 50 on a scale of 100 before the pandemic to more than 75 during the pandemic, according to Dr. Tobin-Schnittger.
When asked how they remembered coping with patient death, one respondent described holding up a phone so a dying patient could hear his daughter’s voice. Another reported not being able to sleep at night.
“I constantly would have dreams that my patients were dying and there was nothing I could do about it,” the respondent said in a survey response.
A third respondent described the experience as ”humbling” but said there were rewarding aspects in patient care during the peak of the pandemic, which helped in being able to focus during difficult days.
Three participants (7.7%) said they changed their career plans as a result of the pandemic experience, the researchers reported.
Negative consequences of the peak pandemic experience included anger, anxiety, professional strain, trauma, and emotional distancing, some respondents reported.
However, others called attention to positive outcomes, such as more professional pride, resilience, confidence, and camaraderie.
“While we did encounter a lot of traumatic experiences, overall, there’s a huge sense that there is a lot more camaraderie within our department, but also within other departments,” said Dr. Tobin-Schnittger. “So I think there are some positives that come from this, and I think there’s been a bit of a culture change.”
Dr. Tobin-Schnittger said that he and his coauthors had no conflicts of interest or relationships with commercial interests to report.
SOURCE: Tobin-Schnittger P. CHEST 2020. Late-breaking abstract. doi: 10.1016/j.chest.2020.09.040.
While the spring peak of COVID-19 was tough and traumatic for many residents and interns in a New York City health system, the experience may have accelerated their patient communication skills regarding difficult goals-of-care discussions, results of a recent survey suggest.
Breaking bad news was an everyday or every-other-day occurrence at the peak of the pandemic for nearly all of 50 of the trainees surveyed, who had worked at hospitals affiliated with the internal medicine residency program at the at the Icahn School of Medicine at Mount Sinai from March to June 2020.
However, trainees became significantly more comfortable and fluent in goals-of-care discussions during the pandemic, according to Patrick Tobin-Schnittger, MBBS, a third-year internal medicine resident in the Mount Sinai program.
“COVID-19 has obviously made a huge impact on the world, but I think it’s also made a huge impact on a whole generation of junior doctors,” said Dr. Tobin-Schnittger, who presented the findings in a late-breaking abstract session at the CHEST Annual Meeting, held virtually this year.
“It’ll be interesting to see what happens in the future as that generation matures, and I think one of the things is that we’re a lot more comfortable with end-of-life care,” he said in an interview conducted during the conference.
Nevertheless, coping with death may still be a challenge for many residents, according to Dr. Tobin-Schnittger. In the survey, internal medicine residents who had rarely encountered patient deaths suddenly found themselves experiencing deaths weekly, with more than one in five saying they were encountering it every day.
When asked to self-rate themselves according to Bugen’s Coping With Death scale, most participants had scores that suggested their ability to cope was suboptimal, the researcher said.
To help trainees cope with local COVID-19 surges, internal medicine residency programs should be implementing “breaking bad news” workshops and educating house staff on resilience in times of crisis, especially if it can be done virtually, according to Dr. Tobin-Schnittger.
“That could be done pretty quickly, and it could be done remotely so people could practice this from home,” he explained. “They wouldn’t even need to congregate in a big room.”
As a “mini-surge” of COVID-19 cases hits the United States, teaching self-care and coping techniques may also be important, said Mangala Narasimhan, DO, FCCP, director of critical care services at Northwell Health in New York City.
“We’ve had several sessions in our health system of letting people vent, talk about what happened, and tell stories about patients that they are still thinking about and haunted by – there was so much death,” Dr. Narasimhan said in an interview.
“People will be suffering for a long time thinking about what happened in March and April and May, so I think our focus now needs to be how to fix that in any way we can and to support people, as we’re dealing with these increases in numbers,” she said. “I think everyone’s panicking over the increase in numbers, but they’re panicking because of the fear of going through what they went through before.”
Dr. Tobin-Schnittger and colleagues sent their survey to 94 residents and interns in the Mount Sinai program who had worked through the peak of the pandemic. They received 50 responses. Of those individuals, the mean age was 29.5 years, and about 46% had worked for more than 3 years.
Before the pandemic, only 3 of the 50 respondents reported having goals-of-care conversations every day or every other day, while during the pandemic, those conversations were happening at least every other day for 38 of the respondents, survey data show.
Self-reported fluency and comfort with those discussions increased significantly, from a mean of about 50 on a scale of 100 before the pandemic to more than 75 during the pandemic, according to Dr. Tobin-Schnittger.
When asked how they remembered coping with patient death, one respondent described holding up a phone so a dying patient could hear his daughter’s voice. Another reported not being able to sleep at night.
“I constantly would have dreams that my patients were dying and there was nothing I could do about it,” the respondent said in a survey response.
A third respondent described the experience as ”humbling” but said there were rewarding aspects in patient care during the peak of the pandemic, which helped in being able to focus during difficult days.
Three participants (7.7%) said they changed their career plans as a result of the pandemic experience, the researchers reported.
Negative consequences of the peak pandemic experience included anger, anxiety, professional strain, trauma, and emotional distancing, some respondents reported.
However, others called attention to positive outcomes, such as more professional pride, resilience, confidence, and camaraderie.
“While we did encounter a lot of traumatic experiences, overall, there’s a huge sense that there is a lot more camaraderie within our department, but also within other departments,” said Dr. Tobin-Schnittger. “So I think there are some positives that come from this, and I think there’s been a bit of a culture change.”
Dr. Tobin-Schnittger said that he and his coauthors had no conflicts of interest or relationships with commercial interests to report.
SOURCE: Tobin-Schnittger P. CHEST 2020. Late-breaking abstract. doi: 10.1016/j.chest.2020.09.040.
FROM CHEST 2020