Sundheds- og Ældreudvalget 2019-20
SUU Alm.del Bilag 109
Offentligt
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Evaluering af Nordic Cochrane
Centre og Copenhagen Trial Unit
Kurt Houlberg, Amalie Martinus Hauge, Morten Sall Jensen, Arendse Tange
Larsen, Astrid Broni Heinemeier og Jakob Kjellberg
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SUU, Alm.del - 2019-20 - Bilag 109: Orientering om evalueringen af Nordic Cochrane Centre og Copenhagen Trial Unit, fra sundheds- og ældreministeren
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Evaluering af Nordic Cochrane Centre og Copenhagen Trial Unit
© VIVE og forfatterne, 2019
e-ISBN: 978-87-7119-725-9
Projekt: 301306
VIVE – Viden til Velfærd
Det Nationale Forsknings- og Analysecenter for Velfærd
Herluf Trolles Gade 11, 1052 København K
www.vive.dk
VIVEs publikationer kan frit citeres med tydelig kildeangivelse.
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Forord
Sundheds- og Ældreministeriet har bedt VIVE om at gennemføre en evaluering af Nordic
Cochrane Centre (NCC) og Copenhagen Trial Unit (CTU).
VIVE har valgt at designe evalueringen som en klassisk forskningsevaluering og har lagt det
ud til et eksternt og uafhængigt evalueringspanel af internationale eksperter at udarbejde en
evalueringsrapport for henholdsvis NCC og CTU.
VIVE har designet og organiseret evalueringen og har i alle evalueringens faser faciliteret eva-
lueringspanelets arbejde. Afrapporteringsmæssigt adskiller evalueringen sig dog fra de fleste
andre VIVE projekter ved, at det ikke er VIVE, der har draget konklusionerne og udarbejdet
evalueringsrapporterne, men et evalueringspanel bestående af internationale eksperter.
I dette ”forklæde” til det internationale evalueringspanels evalueringsrapporter præsenterer
VIVE evalueringens formål og det valgte evalueringsdesign samt sammenfatter de konklusio-
ner, som evalueringspanelet har draget. Evalueringspanelets fulde evalueringsrapporter (på
engelsk) er optrykt i Bilag 3 (NCC) og Bilag 4 (CTU).
VIVE ønsker at sende en stor tak til de to centre og de tre tilknyttede Cochrane Review-grupper
for det store arbejde, de har lagt i evalueringen og for et godt og konstruktivt samarbejde gen-
nem hele evalueringen. Derudover skal der lyde en stor tak til de samarbejdspartnere og inte-
ressenter, som har stillet sig til rådighed for interview mv. i forbindelse med evalueringspanelets
site-visit
og i forbindelse med VIVEs supplerende kvalitative dataindsamling. Endelig skal lyde
en særlig tak til evalueringspanelets medlemmer og ikke mindst panelets formand og næstfor-
mand for et stort, kompetent og engageret evalueringsarbejde.
Evalueringen er bestilt og finansieret af Sundheds- og Ældreministeriet.
Pia Kürstein Kjellberg
Forsknings- og analysechef for VIVE Sundhed
2019
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Indhold
Sammenfatning og konklusion ........................................................................... 5
1
2
Baggrund og formål .................................................................................. 7
Evalueringsdesign..................................................................................... 8
2.1
2.2
2.3
2.4
2.5
Evalueringspanel .......................................................................................... 9
Selvevalueringsrapporter ............................................................................ 11
VIVEs indsamling af supplerende data og materiale .................................. 12
Site-visit og møde i København .................................................................. 13
Høring af evalueringspanelets udkast til evalueringsrapport ...................... 14
Bilag 1
Bilag 2
Bilag 3
Bilag 4
Evalueringsprotokol ....................................................................... 15
Skabelon for selvevalueringsrapport .............................................. 18
Evaluation Report Nordic Cochrane Centre ................................... 35
Evaluation Report Copenhagen Trial Unit ...................................... 65
Litteratur........................................................................................................... 90
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Sammenfatning og konklusion
Sundheds- og Ældreministeriet har bedt VIVE om at gennemføre en evaluering af Nordic
Cochrane Centre (NCC) og Copenhagen Trial Unit (CTU). Denne rapport præsenterer evalu-
eringens formål og design samt sammenfatter evalueringens resultater.
Hovedformålet med evalueringen har været at afklare, hvorvidt formålet bag finanslovsbevillin-
gen til NCC og CTU er opfyldt, samt at undersøge omfanget af forskningsproduktionen og den
forskningsmæssige kvalitet samt centrenes impact og eksterne samarbejdsrelationer.
VIVE har valgt at designe evalueringen som en klassisk forskningsevaluering og har i samar-
bejde med Danmarks Frie Forskningsfond nedsat et eksternt og uafhængigt evalueringspanel
bestående af seks internationale eksperter, som har haft ansvaret for at udarbejde en evalue-
ringsrapport for henholdsvis NCC og CTU.
Det internationale evalueringspanel har udarbejdet evalueringsrapporterne på grundlag af tre
hovedkilder af data:
Selvevalueringsrapporter fra de to centre
Supplerede data og analyser fra VIVE
Et tredages
site-visit
i København.
Evalueringsrapporterne indeholder et ”executive summary” samt evalueringspanelets vurde-
ring af de to centre inden for hvert af følgende fire evalueringstemaer:
1. Ledelse og organisering
2. Forskningsproduktion og kvalitet
3. Impact og relevans
4. Samarbejdsrelationer.
Evalueringspanelets fulde evalueringsrapporter er indsat som Bilag 3 og Bilag 4 i denne rap-
port.
Hovedkonklusion
For begge centre er evalueringspanelets overordnede konklusion, at formålet med finanslovs-
bevillingen er opfyldt.
I evalueringen af NCC
fremhæver evalueringspanelet, at NCC har bidraget til at informere og
kvalificere beslutninger inden for sundhedsområdet gennem tilvejebringelse og syntetisering
af højkvalitets evidensbaseret viden, samt at dette er opnået gennem et betydeligt bidrag til at
forbedre kvaliteten af den evidens, der er til rådighed for beslutningstagere, inklusive patienter
og offentligheden. Dette er sket gennem udviklingen af robuste metoder og advokering for brug
af disse gennem publicering i
high-impact
forskningstidsskrifter og gennem træning. Feedback
fra interessenter peger endvidere på, at NCC har et godt omdømme baseret på kvaliteten,
uafhængigheden og vigtigheden af centerets arbejde og ophænget til Cochranes overordnede
mission. Evalueringspanelet ser dog også et behov for et tættere samarbejde mellem NCC og
de i Danmark lokaliserede Cochrane Review-grupper samt en øget involvering af interessenter
og for reetablering af et advisoryboard af medlemmer med tilknytning til den sundhedspolitiske
dagsorden og kliniske dagsorden i Danmark.
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I evalueringen af CTU
fremhæver evalueringspanelet, at CTU, ifølge panelets vurdering, har
indfriet centerets primære mål om at støtte, koordinere og gennemføre randomiserede kliniske
forsøg, deltagelse i udviklingen af metoder til randomiserede kliniske forsøg og meta-analyser,
uddanne studenter og forskere i evidensbaseret medicin, randomiserede kliniske forsøg, meta-
analyser og sekventielle analyser; og støtte, koordinere og gennemføre systematiske reviews
af litteraturen. Evalueringspanelet vurderer endvidere, at CTU har publiceret sin forskning i en
vifte af
high-impact
forskningstidsskrifter, og at centerets studier har haft betydelig impact gen-
nem indvirkning på klinisk praksis og stimulering af offentlig debat og diskussion.
Behov for at overveje muligheden for et ændret organisatorisk setup
Trods de to centres anseelige præstationer og den overordnede konklusion om, at formålet
med finanslovsbevillingen er opfyldt, stiller evalueringspanelet for både NCC og CTU spørgs-
målstegn ved bæredygtigheden af den nuværende organisationsmodel i lyset af centrenes be-
grænsede størrelse, afhængighed af ministeriel finansiering, placering på Rigshospitalet og
komplekse styringsstruktur. Evalueringspanelet konkluderer således, at der for både NCC og
CTU er et presserende behov for at overveje mulighederne for et ændret organisatorisk setup.
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Baggrund og formål
Sundheds- og Ældreministeriet har bedt VIVE om at gennemføre en evaluering af Nordic
Cochrane Centre og Copenhagen Trial Unit.
Baggrunden er, at Nordic Cochrane Centrr (NCC) og Copenhagen Trial Unit (CTU) hvert år
modtager en finanslovsbevilling. I Finansloven for 2018 var den samlede bevilling til de to cen-
tre på 17,8 millioner kroner.
I finansloven står, at
”Aktiviteterne indenfor Cochrane området omfatter bl.a. udarbejdelse af
systematiske oversigter over sundhedsvæsenets interventioner, forebyggelse af sygdomme,
diagnostik, behandling og pleje. CTU understøtter og udfører videnskabeligt relevante kliniske
forsøg, bl.a. som led i Cochrane-samarbejdet”
(Finansloven 2018, § 16.51.03.45).
Hovedformålet med evalueringen er at afklare, hvorvidt formålet bag finanslovsbevillingen er
opfyldt, samt at undersøge omfanget af forskningsproduktionen og den forskningsmæssige
kvalitet samt centrenes impact og eksterne samarbejdsrelationer.
Konkret sætter evalueringen fokus på følgende fire evalueringstemaer:
1. Ledelse og organisering
2. Forskningsproduktion og kvalitet
3. Impact og relevans
4. Samarbejdsrelationer.
Ud over NCC og CTU omfatter evalueringen også de tre Cochrane Review-grupper, som er
lokaliseret i Danmark:
1. The Cochrane Colorectal Group (CCG),
2. The Cochrane Anaesthesia Group and the Emergency and Critical Care Group (ACE)
3. The Cochrane Hepato-Biliary Group (CHBG).
Evalueringen er designet som en klassisk forskningsevaluering. Heri ligger blandt andet, at
evalueringen af de to centre og udarbejdelsen af evalueringsrapporterne er foretaget af et eva-
lueringspanel bestående af internationale eksperter. Evalueringspanelet har udarbejdet en en-
gelsksproget evalueringsrapport for henholdsvis NCC og CTU. Disse to evalueringsrapporter
er indsat som Bilag 3 og Bilag 4 i denne rapport og indeholder begge et ”executive summary”
samt en vurdering af de fire evalueringstemaer.
Evalueringspanelets sammensætning og det samlede evalueringsdesign er nærmere beskre-
vet i kapitel 2,
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Evalueringsdesign
Evalueringen af NCC og CTU anlægger en klassisk tilgang til forskningsevalueringer. Baseret
på en kombination af kvantitative og kvalitativ data er der indsamlet viden om både forsknings-
centrenes videnskabelige produktion og dens kvalitet samt centrenes forskningsmæssige im-
pact i samfundet.
Inden for forskningsevaluering er der en række forskellige tilgange og metoder, som hver især
trækker visse elementer ved institutionen i forgrunden (Hansen, 2009; Garret-Jones, 2000).
Forskningsevalueringer fokuserer typisk på enten forskningens indflydelse i det akademiske
miljø eller i samfundet generelt. Indflydelse i det akademiske miljø undersøges via data om
forskningsproduktionen, dennes impact og institutionens relationer i det akademiske miljø. Ind-
flydelse i samfundet undersøges via data om deres nytte og betydning for samfundet, samt om
hvordan institutionen indgår i samspil med omgivelserne.
Det primære formål med et evalueringsdesign er, at det indhenter de data, der er relevante for
evalueringens formål i egnet omfang og format. Data som ofte bruges til forskningsevaluering
er kvantitative opgørelser over forskningsproduktionen gennem fx optælling af forskningspro-
duktion, brug af bibliometriske forskningsindikatorer og citationsanalyser (se fx Hidalgo og
Espinar, 2017). Derudover anvendes også kvalitative data som fx interview og peer-review.
Ofte kombineres disse metoder (Pedersen, 2017; Hansen 2009), hvilket også er denne evalu-
erings fremgangsmåde.
Evalueringen af NCC og CTU følger dermed den gængse fremgangsmåde for forskningseva-
luering, og i evalueringsdesignet har VIVE lagt vægt på:
at selve evalueringen foretages af internationale, uvildige eksperter på området, som
sammensættes i et evalueringspanel
at de to centre foretager en selvevaluering på baggrund af en skræddersyet evalue-
ringsskabelon, udviklet og kvalitetssikret af VIVE
at VIVE både selvstændigt og på forespørgsel af evalueringspanelet indhenter rele-
vante data til at supplere selvevalueringerne
at evalueringspanelet mødes på centrene (site-visit) og vurderer det materiale, som er
indhentet om centrene
at evalueringspanelet udarbejder evalueringerne på baggrund af selvevalueringerne,
supplerede data og analyser udarbejdet af VIVE samt fra evalueringspanelets site-visit.
at der udarbejdes selvstændige evalueringsrapporter for hvert af de to centre.
Den samlede evalueringsproces er illustreret i Figur 1.
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Figur 1:
Evalueringsprocessen
Nedsættelse af evaluerings-
panel
Udarbejdelse af skabelon for
selvevaluering
Evalueringspanel fastsætter
temaer for VIVEs data-
indsamling
- NCC/CTU udarbejder
selvevaluering
- VIVE indsamler supplerende
materiale
Materiale tilgår evalueringspanel
Site-visit af evalueringspanel:
- drøftelse af selvevaluering
- specifikke drøftelser
- efterspørgsel af suppl. data
NCC/CTU + VIVE genererer
eventuelle supplerende data
Evalueringspanel udarbejder
evalueringsrapport
Hovedelementerne i evalueringsdesignet er beskrevet nærmere nedenfor
2.1 Evalueringspanel
For at sikre en uvildig og kvalificeret evaluering er nedsat et evalueringspanel bestående af
internationale eksperter. Det er evalueringspanelet, der har udarbejdet den endelige evalue-
ring, og det er panelet, som står som afsender af evalueringen. Evalueringspanelets rapport
dækker følgende områder:
1. Ledelse og organisering
2. Forskningsproduktion og kvalitet
3. Impact og relevans
4. Samarbejdsrelationer.
Formanden for evalueringspanelet har i samarbejde med panelets næstformand haft det over-
ordnede ansvar for evalueringspanelets arbejde og udarbejdelse af evalueringen.
Formanden for evalueringspanelet er blevet udpeget af Danmarks Frie Forskningsfond (DFF)
efter indstilling fra VIVE. Ved indstillingen af formanden for evalueringspanelet er der blevet
lagt vægt på, at denne skulle være en international anerkendt forsker inden for det kliniske
område, have kendskab til det ledelsesmæssige og strategiske arbejde med forskningsinstitu-
tioner på internationalt niveau samt have erfaring med at lede store, internationale forsknings-
projekter og/eller forskningscentre. I valget af formand er endvidere lagt stor vægt på uvildighed
i forhold til de to centre, og der er foretaget individuelle vurderinger af, om mulige kandidater til
formandsposten har en tilpas distance til både de danske organisationer og disses internatio-
nale bagland.
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VIVE har udpeget de øvrige medlemmer af evalueringspanelet efter indstilling fra DFF. VIVE
bad DFF om at indstille tre internationalt anerkendte forskere fra det sundhedsvidenskabelige
råd under DFF
1
og to internationalt anerkendte forskere fra det samfundsvidenskabelige råd
under DFF
2
. Kandidaterne fra det sundhedsvidenskabelige råd skulle have indsigt i processer
og metoder knyttet til brugen af randomiserede studier, systematiske reviews og erfaring med
at vurdere kvaliteten og relevansen af sundhedsfaglig forskning. Kandidaterne fra det sam-
fundsvidenskabelige råd skulle have indsigt i organisering og ledelse af forskningscentre på
sundhedsområdet samt have indsigt i det danske sundhedsvæsens organisering og ledelse.
For at sikre evalueringens uvildighed var det endvidere et vigtigt kriterium, at panelmedlem-
merne ikke måtte have haft tæt samarbejde eller andre tætte relationer med de to centre eller
deres internationale baglandsorganisationer de sidste fem år, som kunne give anledning til
habilitetsproblemer i forhold til evalueringen af de to centre. I overensstemmelse med ligestil-
lingsloven indstiller DFF både en mand og en kvinde til hver plads i evalueringspanelet.
Efter at DFF havde gennemført en proces med indstilling og udsendelse af invitationer til de
indstillede, modtog VIVE en liste fra DFF med fem forskere fra det sundhedsvidenskabelige
råd og to forskere fra det samfundsvidenskabelige råd. På grundlag af denne liste udpegede
VIVE efter samråd med evalueringspanelets formand de øvrige medlemmer af evalueringspa-
nelet. Baseret på en samlet vurdering af kandidaternes individuelle og komplementære kvalifi-
kationer udpegede VIVE tre af de fem forskere, som havde accepteret invitationen fra det sund-
hedsvidenskabelige råd, og de to forskere, som havde accepteret invitationen fra det sam-
fundsvidenskabelige råd. Alle panelmedlemmer er udpeget i kraft af deres personlige kompe-
tencer. Sammensætningen af udvalget har været i høring hos NCC og CTU.
Evalueringspanelet består samlet set af seks medlemmer med komplementære kompetencer
inden for sundhedsvidenskabelige reviews, klinisk forskning,
trials
samt ledelse og organise-
ring af sundhedsforskning:
Amanda Sowden (formand). Professor and Deputy Director and leader of the University
of York’s Centre for Reviews and Dissemination’s research programme in public health,
United Kingdom
Terje P. Hagen (næstformand). Professor and Head at the Institute of Health and Soci-
ety, University of Oslo, Norway
Diederick Grobbee. Professor of Clinical Epidemiology and founder of the Julius Center,
University Medical Center Utrecht, The Netherlands
Eva Swahn. Professor at the Department of Medical and Health Sciences, Division of
Cardiology, Linköping University & the Department of Cardiology, University Hospital,
Linköping, Sweden
Merete Osler. Clinical Professor at the Department of Public Health, University of Co-
penhagen & Consultant at the Center for Clinical Research and Prevention, Bispebjerg
and Frederiksberg Hospital, Denmark
Mickael Bech. Professor in healthcare leadership at Crown Prince Frederik Center for
Public Leadership, Aarhus University, Denmark.
Dette internationale evalueringspanel har udarbejdet evalueringsrapporterne for henholdsvis
NCC og CTU. Panelets arbejde med at evaluere de to centre har været baseret på en
1
2
Danmarks Frie Forskningsfond | Sundhed og Sygdom
Danmarks Frie Forskningsfond | Samfund og Erhverv (FSE)
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evalueringsprotokol med konkrete evalueringsspørgsmål (se Bilag 1) og tre hovedkilder af
data:
1. Selvevalueringsrapporter fra de to centre
2. Supplerede data og analyser fra VIVE
3. Et tredages
site-visit
i København.
Disse datakilder beskrives i de efterfølgende tre afsnit.
Evalueringspanelets arbejde har bestået dels af møder/site-visits, dels af vurdering af udsendt
skriftligt materiale. Panelet har mødtes i København i forbindelse med site-visits, hvor der også
har været afholdt arbejdsmøde. Panelet har fået tilsendt de to centres selvevaluering forud for
mødet i København samt supplerede data og analyser fra VIVE.
2.2 Selvevalueringsrapporter
Selvevalueringsrapporterne har skullet give evalueringspanelet viden om centrene og en for-
ståelse for deres nuværende situation og de udfordringer, som centrene står overfor. NCC og
CTU har udarbejdet hver deres selvevalueringsrapport, baseret på en evalueringsskabelon
udarbejdet af VIVE, og kommenteret og kvalitetssikret af formanden for evalueringspanelet. I
udviklingen af evalueringsskabelonen er der blevet lagt vægt på, at den skulle indhente data,
som er dækkende, systematiske og velunderbyggede. Hvert center har været ansvarlig for
udarbejdelsen af deres selvevalueringsrapport, og de har selv afgjort, hvordan arbejdet med
selvevalueringen skulle organiseres.
Den samlede skabelon for selvevalueringsrapporten er gengivet i Bilag 2 (på engelsk).
Selvevalueringsskabelonen indeholder i oversigtsform følgende hovedelementer:
Beskrivelse af centerets strategi, organisering, ledelse og økonomi
NCC og CTU skal her redegøre for deres vision og strategi, hvilke tiltag der er igangsat for
realiseringen af vision og strategi, samt hvordan opfølgningen på de strategiske målsætninger
sikres. Centrene skal beskrive, hvordan de er organiseret og ledet, hvorledes dette understøt-
ter deres arbejde og realisering af strategi og vision. De skal foretage en beskrivelse af deres
grundlæggende organisering, ledelsens opgaver og placering samt de forskellige støttefunkti-
oner på centrene. De skal også fremlægge en redegørelse for deres økonomi, økonomistyring
og deres evne til at tiltrække eksterne ressourcer fra fx forskningsråd, fonde og EU.
Forskningsproduktion og forskningskvalitet
Centrene skal her opgøre og kvalitetsvurdere deres forskningsproduktivitet. Opgørelsen om-
fatter en optælling af publikationer de seneste fem år fordelt på seks hovedtyper: peer-review
artikler, Cochrane Reviews, Cochrane Protocols, bidrag til bøger, bidrag til konferencer og an-
den forskningsformidling (forskellige medier) for centrene. Som led i dette opgøres årlige gen-
nemsnitstal af publikation pr. forsker og pr. bevilligede million kroner. Endvidere skal centrene
redegøre for deres undervisningsaktivitet samt antallet af ph.d.-afhandlinger de seneste fem
år, påbegyndte ph.d.-forløb, igangværende ph.d.-forløb, samt hvor ph.d.-kandidaterne har fået
ansættelse.
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For at vurdere kvaliteten af forskningen skal artikler publiceret de seneste fem år inddeles efter
de forskningstidsskrifter, hvor de er publiceret, ligesom centrene skal redegøre for, hvilke forsk-
ningstidsskrifter de anser for at være top forskningstidsskrifter for publicering af centerets forsk-
ning.
Impact og relevans
Centrene skal her redegøre for, hvordan deres forskning og aktiviteter bruges og skaber nytte
forskellige steder i det danske samfund. Det skal bl.a. bidrage til at vurdere relevansen af den
forskning, som centrene bedriver. Redegørelsen skal dække følgende punkter:
Eksempler på mulig indvirkning på behandlingspraksis og kliniske retningslinjer de se-
neste fem år
Samarbejde med offentlige myndigheder de seneste tre år
Samarbejde med sygehuse og sundhedspersonale de seneste tre år
Deltagelse i rådgivning, kommissioner, nævn m.m. de seneste tre år
Arrangør af konferencer, symposier og andre vidensdelende aktiviteter de seneste tre
år
Andre måder, som centerets forskning og aktiviteter er blevet brugt på, som har bidraget
til værdi for det danske samfund inden for de seneste tre år.
Opgørelsen skal underbygges af dokumentation for impact og relevans.
Samarbejdspartnere – nationalt og internationalt
NCC og CTU skal her redegøre for, hvilke eksterne parter de har formelle samarbejdsaftaler
med – både nationalt og internationalt. Redegørelsen skal angive typen af samarbejde, hvilken
rolle centrene spiller i samarbejdsrelationerne, hvilket output samarbejdet har resulteret i, og
hvordan samarbejdet har bidraget til realiseringen af centrenes målsætninger.
2.3 VIVEs indsamling af supplerende data og materiale
Efter dialog med formanden for evalueringspanelet har VIVE indsamlet yderligere data og fo-
retaget supplerende analyser til evalueringspanelet inden for de fire overordnede temaer:
1. Ledelse og organisering
2. Forskningsproduktion og kvalitet
3. Impact og relevans
4. Samarbejdsrelationer.
Selvevalueringen giver et vigtigt input til evalueringen, men de supplerende data og analyser
gør det muligt for evalueringspanelet at få et bedre og mere dybdegående grundlag for evalu-
eringen.
Ledelse og organisering
For at sikre et relevant sammenligningsgrundlag i forhold til centrenes ledelse og organisering
har VIVE for evalueringspanelet afdækket, hvordan udvalgte centre med sammenlignelige
forskningsaktiviteter er organiseret og ledet. Der er blevet udvalgt to centre til sammenligning
med NCC og to centre til sammenligning med CTU.
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Forskningsproduktion og kvalitet
Som supplement til opgørelserne i selvevalueringsrapporten har VIVE foretaget en opgørelse
af de to centres involvering i forskningsaktiviteten ved en citationsanalyse. Da begge centre
primært publicerer i kliniske tidskrifter, opgøres de årlige antal af første-, med- og sidste forfat-
terskaber for centrene
3
. Dernæst opgøres antallet af citationer for publicerede artikler for de
sidste fem år, hvilket vurderes at give et mål for relevansen af de publicerede artikler, da et
højt citationsantal betyder, at andre forskere har brugt resultaterne i deres artikler og derfor
finder forskningen relevant. I forlængelse heraf udregnes to forskellige indikatorer for, om ar-
tiklen er citeret mere eller mindre end gennemsnittet for de valgte forskningstidsskrifters artik-
ler. Som sidste del opgøres de bibliometriske forskningsindikator point (BFI-point) for de pub-
licerede artikler.
Impact og relevans
For at afdække, hvordan eksterne parter, som offentlige myndigheder og sygehuse, vurderer
betydningen af centrenes arbejde, har VIVE foretaget interview med relevante samarbejds-
partnere. Disse er blevet udvalgt, så der er sikret en bred repræsentation af forskellige aktører
og samarbejdsparter.
Samarbejdsrelationer
Med afsæt i de samarbejdspartenere og samarbejdsrelationer, som er fremgået af selvevalu-
eringen, har VIVE foretaget en nærmere analyse af, hvem der samarbejdes med, typen af og
indholdet i samarbejdet. Dette er blevet gjort ved at foretage kvalitative interview med to til fire
af de samarbejdspartnere, centrene har peget på i deres selvevaluering med henblik på at få
deres perspektiv på samarbejdet.
2.4 Site-visit og møde i København
Efter at have fået tilsendt selvevalueringsrapporterne og det supplerende materiale fra VIVE,
har evalueringspanelet den 20.-22. maj 2019 været på et tredages
site-visit
i København. I
programmet var der afsat en dag pr. center til besøg. Besøget skulle give evalueringspanelet
mulighed for at få et generelt indtryk af centrene og samtidig have mulighed for at drøfte selv-
evalueringen med centrene.
Programmet for evalueringspanelets besøg på centrene omfattede følgende punkter:
Introduktion og rundvisning
Møde med centrenes ledelse/evalueringsgruppe om selvevalueringen
Interview med udvalgte medarbejdere
Interview med eksterne samarbejdspartnere
Interview med repræsentanter for Cochrane Review-grupper.
Herudover omfattede programmet for evalueringspanelets tre dage i København et interview
med Rigshospitalets ledelse, et Skype-møde med direktøren for den internationale Cochrane
organisation, Mark Wilson, samt en række arbejds- og planlægningsmøder internt i evalue-
ringspanelet eller mellem VIVE og evalueringspanelet.
3
Dette er indikatorer for involveringen i forskningsproduktiviteten, da førsteforfattere typisk er primær skriver på artiklen,
medforfattere har bidraget i varierende grad og sidste forfatterskab typisk er seniorforsker (lektor eller professor). Første-
og sidste forfatter vurderes at være de mest prestigefyldte pladser i forfatterrækkefølgen i medicinsk litteratur (Caminiti
2015).
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2.5
Høring af evalueringspanelets udkast til evalueringsrapport
I perioden efter besøgsdagene i København har evalueringspanelet foretaget en samlet vur-
dering af evalueringsdataene fra selvevalueringsrapporter, supplerende materiale fra VIVE og
site-visit og har på grundlag af dette udarbejdet et udkast til evalueringsrapport for henholdsvis
NCC og CTU. Disse udkast er herefter blevet sendt til høring hos de to centre, de tre tilknyttede
Cochrane Review-grupper samt Sundheds- og Ældreministeriet. Efter at have modtaget hø-
ringssvarene og forholdt sig til disse har evalueringspanelet udarbejdet de endelige evalue-
ringsrapporter.
Evalueringspanelets endelige evalueringsrapporter er gengivet i Bilag 3 (NCC) og Bilag 4
(CTU).
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Bilag 1
Evalueringsprotokol
Dette bilag indeholder projektets evalueringsprotokol, dvs. de evalueringsspørgsmål, som har
været styrende for evalueringspanelets arbejde med at evaluere de to centre. Evalueringspro-
tokollen er udarbejdet af VIVE i samarbejde med evalueringspanelets formand.
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Evaluation protocol
Evaluation of The Nordic Cochrane Centre and Copenhagen Trial Unit
The Nordic Cochrane Centre (NCC) and Copenhagen Trial Unit (CTU) receive each year a
grant under the National Finance Act. According to the Finance Act, the activities at the
Cochrane Centre include production of systematic reviews of health care interventions, pre-
vention of diseases, diagnostics, treatment and care, and that CTU supports and conducts
scientifically relevant clinical trials. The main purpose of the evaluation is to assess whether
the purpose of the National Finance Act grant is fulfilled, to evaluate the scale of the research
production and its research quality as well as the societal impact of the centres and their ex-
ternal collaborations and partnerships. Accordingly the evaluation both include formative ele-
ments focusing on broadening the understanding of the institute's characteristics for the pur-
pose of continuous improvement and summative elements focusing on accountability to the
entity that funds the running of the centre.
Specifically, the evaluation must address the following topics:
Management and organization of the centres
Research production and quality
Impact and relevance of the centres’ activities
Collaborations and partnerships
An external evaluation panel carries out the evaluation. The members of the panel are
acknowledged national and international experts within medicine and evaluation of re-
search. The basis for the evaluation include the following:
Self-evaluation reports by NCC and CTU
Site-visit by the evaluation panel
Documentation and additional data collected by VIVE – The National Centre for Social
Science Research.
The result of the evaluation is presented in separate reports for each of the two institutions.
The purpose of the evaluation is not to compare the two institutions but to give individ-
ual assessments of each centre.
In the following, the topics of the evaluation are described further.
Management and organization
The evaluation panel is asked to give a general description and assessment of the governance
structure and the management and organizational structure of the centre. The description and
assessment should address the following:
An overall description and assessment of the governance structure of the centre, includ-
ing reflections on the governance structures ability to hold the management of the cen-
tre accountable
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A reflection on the strategy of the centre in relation to the purpose and mission of the
centre
A description and assessment of the management and organizational structure of the
centre, including reflections on the organizational and management structures ade-
quacy for accomplishing the centre´s purpose and strategy, and the expediency of the
decision-making structure and the division of labor between the different sections of
the centre
An assessment of the organizational support for researchers
An assessment of the centre’s ability to attract external resources from research coun-
cils, research funds, EU etc.
A reflection on the expediency of governance structure, the management and organiza-
tional structure compared to similar type of institutions.
Research production and quality
The panel is asked to give an assessment of the quantity and quality of research from the
centre. The assessment should include the following elements:
A count of publications over the past five years divided into main types of publications
The average number of annual publications per researcher for the centre at large
An assessment of the quality of research based on bibliometric indicators
Reflections on the level and quality of output compared to economic resources
An assessment of the centres’ production of PhD candidates, including reflections on
the centres’ involvement in PhD programs
An overall assessment of the productivity of the centre and the importance and quality
of the research.
Impact and relevance
The evaluation panel is asked to give its assessment of the impact and relevance of the centre’s
activities for the Danish society. The assessment should include the following elements:
An assessment of the impact of the centre on clinical practice and clinical guidelines.
Reflections on how the centres research and other activities create value in various
parts of the Danish society
Reflections on the centres’ impact on the public debate in Denmark
Collaborations and partnerships
The evaluation panel is asked to give its assessment of the centres national and international
collaborations and partnerships. The assessment should include the following elements:
An assessment of the level of national and international collaboration of the centre, in-
cluding reflections on the level of national vs. international collaborations, and the role
of the centre in the collaborations
An assessment of the output of the collaborations
Reflections on importance of the collaboration for accomplishing the centre´s purpose
and strategy.
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Bilag 2
Skabelon for selvevalueringsrapport
Dette bilag indeholder den skabelon for selvevalueringsrapport, som de to centre har brugt i
udarbejdelsen af deres respektive selvevalueringsrapporter. Selvevalueringsskabelonen er ud-
arbejdet af VIVE i samarbejde med evalueringspanelets formand.
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Self-evaluation report template
Guidelines for the self-evaluation report
Evaluation of The Nordic Cochrane Centre and Copenhagen Trial Unit
It is the centre’s responsibility to draw up the self-evaluation document based on the guidelines given in
this guide. The centre is responsible for establishing the mechanisms for collecting information on the
centre needed to cover the themes mentioned in the guide, and to provide the requested documenta-
tion. The centre is free to increase the amount of evidence with the aim of broadening the scope of in-
formation provided and thereby improve the evaluation.
The self-evaluation report is a key part of the evaluation and together with the site-visit, the main evi-
dence for the external review process. The drawing up of the self-evaluation document by the centre
must enable the external review panel to know about and understand the centre's standing. The report
should be complete and rigorous, include evidence and documentation, systematic and detailed, and
balanced.
The self-evaluation report should cover the following themes:
Management and organization
Research production and quality
Impact and relevance
Collaborations and partnerships.
Use the centre’s own word-template for the report and structure the report according to this self-evalua-
tion template. Use Times New Roman 12 and single-spaced text. Include a front page and an index at
the start of the report.
1
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1. Strategy, organization, management and economy
1.1
1.1.1
History and governance structure
Overview of the history of the centre
Please give a brief overview of the history of the centre, including a description of when,
how and why the centre was established and the most important changes in the organi-
sational setup and basic funding since the establishment.
1.1.2
The overall governance setup of the centre
Please describe which authority holds the contract for the centre and the centre’s con-
tractual relationship with this authority
1.1.3
1.1.4
How does the centre seek advice and support about its vision/mission and strategy?
Does the centre have and use a board
1
?
If the centre has a board or similar structure, please provide information about:
a) The role of the board
b) The election of members, their obligations, their compensation
c) How and how often the board is involved in the centre’s activities (i.e.
through regular meetings, ad-hoc consultations etc.)
d) One or more example(s) illustrating the role of the board for the centre.
If the centre does not have a board, please provide reflections upon this choice.
1.1.5
Does the centre have and use an advisory board
2
?
If the centre has an advisory board or similar structure, please provide information about:
a) The role of the advisory board
b) The election of members, their obligations, compensation
c) How and how often the advisory board is involved in the centre’s activities (i.e.
through regular meetings, ad-hoc consultations etc.)
d) One or more example(s) illustrating the role of the advisory board for the centre.
If the centre does not have an advisory board, please provide reflections upon this choice
1.1.6
The governance structure’s ability to hold the management of the centre accountable
Board or ’board of directors’ is a group of individuals formally elected by shareholders to oversee or
manage an organization
2
An advisory board is a group of individuals that provides non-binding strategic advice to the manage-
ment of an organization.
1
2
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Please elaborate on the ways in which the described governance structure enables ac-
countability.
Please reflect: Which opportunities for improvement do you see?
1.1.7
Relevant documents and additional information
Please provide documents and information that you consider relevant for the evaluation
of the centre’s governance structure.
1.2
1.2.1
Management and organization
Describe the centre’s organizational and economic relationship to each of the following organi-
zations:
a)
b)
c)
d)
The hosting organization, The Copenhagen University Hospital (‘Rigshospitalet’)
The other of the two centres
The three Danish Cochrane Review Groups
The Cochrane Organization
1.2.2
Which managerial positions exist at the centre and what are their tasks and responsibilities?
Please provide a description of all managerial positions of the centre, including the follow-
ing topics:
a) Title and managerial position
b) Primary task(s)
c) Staff responsibility (yes/no), If yes: number of staff members
1.2.3
How is the centre organized?
Please provide organizational diagram and/or description of the hierarchical structure of
the centre, illustrating the organization’s division of labour.
1.2.4
How does the centre provide organizational support for its researchers?
Please describe the support functions for researchers available within the organization.
Please describe the support functions for researchers made available by the centre out-
side of the organization.
1.3
1.3.1
Vision and strategy
What is the centre’s vision, mission and/or goals?
Please describe the centre’s vision, mission and/or goals of the centre
1.3.2
What is the centre’s strategy?
3
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2119238_0022.png
Please describe the centre’s strategy, as well as the development process resulting in the
formulation of the centre’s strategy and the time period of the strategic plans and how fre-
quently are they assessed
1.3.3
How are the vision and strategy anchored in the centre’s activities?
Please describe the organizational activities specifically conducted to reflect upon, de-
velop or adjust the centre’s achievements of goals and strategy
1.3.4
Relevant documents and additional information
Please provide documents and documentation relevant to review the centre’s vision/mis-
sion and strategy, including but not limited to annual reports for the last five years
1.4
1.4.1
Economy and budget
How is the centre funded?
Please provide information about funding sources for the last five years, including both
government funding and other sources.
Please report in million DKK in 2018-prices with two decimals. Use figures from final ac-
counts if available. For years, where final accounts are not available, use budgets and
mark the year with a ‘B’.
In the first table, please exclude any funds for Danish Cochrane Review Groups affiliated
with the centre
Table 1.1. The Centre’s revenues 2014-2018 (excluding Cochrane Review Groups affiliated with
the centre)
Million DKK 2018 prices
\ year
Government grant (National Fi-
nance Act)
Research councils and research
funds
EU
The Copenhagen University Hos-
pital (‘Rigshospitalet’)
Other revenues (including reim-
bursement of wage expenses by
external collaboration partners)
Total revenues
2014
2015
2016
2017
2018
4
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Please describe the source of the most important “other revenue” sources
Please provide the same information for the Danish Cochrane Review Groups affiliated
with the centre
Table 1.2. Revenues for Danish Cochrane Review Groups affiliated with the centre
Million DKK 2018 prices
\ year
Government grant (National Fi-
nance Act)
Research councils and research
funds
EU
The Copenhagen University Hos-
pital (‘Rigshospitalet’)
Other revenues (including reim-
bursement of wage expenses by
external collaboration partners)
Total revenues
2014
2015
2016
2017
2018
Please provide information about the distribution of expenditures for the last five years,
including both wage costs and other operating costs.
Please report in million DKK in 2018-prices with two decimals. Use figures from final ac-
counts if available. For years where final accounts are not available use budgets and
mark the year with a ‘B’.
In the first table, please exclude expenditures for Danish Cochrane Review Groups affili-
ated with the centre
Table 1.3. The Centre’s expenditures 2014-2018 (excluding Cochrane Review Groups affiliated
with the centre)
Million DKK 2018 prices
\ year
Wage expenses:
Researchers, including manage-
ment (excluding PhD’s)
PhD’s
Administrative functions
Other employees
2014
2015
2016
2017
2018
5
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Reimbursement for employees on
sickness leave or maternity/pa-
rental leave (revenue)
Total wage expenses
Operating expenses:
Premises (rent, utility ex-
penses for water, heating etc.)
Office expenses (IT equip-
ment, printers, paper etc.)
Conferences and other aca-
demic activities
Other operating expenses
Total operating expenses
Total expenditures (wages
and operating expenses)
Table 1.4. Expenditures 2014-2018 for Cochrane Review Groups affiliated with the centre
Million DKK 2018 prices
\ year
Wage expenses:
Researchers, including manage-
ment (excluding PhD’s)
PhD’s
Administrative functions
Other employees
Reimbursement for employees on
sickness leave or maternity/pa-
rental leave (revenue)
Total wage expenses
Operating expenses:
2014
2015
2016
2017
2018
Premises (rent, utility ex-
penses for water, heating etc.)
Office expenses (IT equip-
ment, printers, paper etc.)
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Conferences and other aca-
demic activities
Other operating expenses
Total operating expenses
Total expenditures (wages
and operating expenses)
Please report the number of employees
(Full Time Equivalents/FTE)
at the centre for the
last five years.
In the first table, please exclude employees at Danish Cochrane Review Groups affiliated
with the centre
Table 1.5. Employees (FTE) at the centre (excluding employees at Danish Cochrane Review
Groups affiliated with the centre)
Full Time Equivalent/FTE
\ year
Researchers, including manage-
ment (excluding PhD’s)
PhD’s
Administrative functions
Other employees
Total number of employees
(FTE) excluding Danish
Cochrane Review Groups affili-
ated with the centre
2014
2015
2016
2017
2018
Table 1.6. Employees (FTE) at Danish Cochrane Review Groups affiliated with the centre
Full Time Equivalent/FTE
\ year
Researchers, including manage-
ment (excluding PhD’s)
PhD’s
Administrative functions
Other employees
2014
2015
2016
2017
2018
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Total number of employees
(FTE) at Danish Cochrane Re-
view Groups affiliated with the
centre
1.4.2
How successful is the centre in attracting funds?
Please provide a list of fund applications from the last five years, including the name of
the fund/organization, the applied for amount, status (rejected/granted), and if relevant,
the amount granted.
1.4.3
How is the use of resources linked to the centre’s vision/strategy?
Please describe how the centre allocates resources. Include a description of how it is pri-
oritized which clinical fields are to be the subject of reviews to be conducted in the com-
ing year(s). If relevant, describe how the resource allocation is related to the centre’s
goals and to the dimensioning of workload (Full Time Equivalent/FTE).
1.4.4
How is the financial management of the centre organized and linked to the centre’s vision/strat-
egy?
Please describe how the financial management of the centre is organized. If relevant, de-
scribe how the resource allocation and financial management is related to the centre’s
goals and to the dimensioning of workload (Full Time Equivalent/FTE).
1.4.5
Relevant documents and additional information
Please provide documents and information that you consider relevant for the evaluation
of the centre’s budgetary and financial accountability.
8
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2 Research production and quality
2.1
2.1.1
Research production
The centre’s publication list for the last seven years.
In addition, to the accounts of publications below, please provide a full list of all publications for the past
seven years (01.01.2012-31.12.2018) for VIVEs analysis of citations. The list should be based on
PURE, and exported from PURE in CSV file. It is expected that all publications are available in PURE
for each researcher. If the publications are not found in PURE, they are not counted in the final evalua-
tion.
2.1.2
The centre’s research production for the last five years?
Please count the yearly scientific output of PURE publications for the last five years in the main catego-
ries of publications presented in the table below. Please provide the count for each year from 2014-
2018.
In the first table, please exclude publications by Danish Cochrane Review Groups affiliated with the cen-
tre
Table 2.1 Number of publications (excluding publications by Danish Cochrane Review Groups affiliated with the
centre)
Publication type \ year
Peer-reviewed journal articles
New Cochrane Reviews
Updated Cochrane Reviews
Cochrane Protocols
PhD/doctoral dissertations
Contributions to books (books
and book chapters)
Conference contributions
Other publications and none-
peer-reviewed dissemination of
research (reports, letters, com-
ments etc.)
Total (excluding publications
by Danish Cochrane Review
Groups affiliated with the cen-
tre)
2014
2015
2016
2017
2018
Total
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Table 2.2 Number of publications by Danish Cochrane Review Groups affiliated with the centre
Publication type \ year
Peer-reviewed journal articles
New Cochrane Reviews
Updated Cochrane Reviews
Cochrane Protocols
PhD/doctoral dissertations
Contributions to books (books
and book chapters)
Conference contributions
Other publications and none-
peer-reviewed dissemination of
research (reports, letters, com-
ments etc.)
Total (by Danish Cochrane
Review Groups affiliated with
the centre)
2014
2015
2016
2017
2018
Total
2.1.3
Number and type of studies in Cochrane Reviews
If relevant, please reflect upon trends over the last five years in the number and the type of studies in-
cluded in each Cochrane Review as well as the overall complexity of the reviews.
2.1.4
Prioritizing of Cochrane Reviews
Please provide information about how Cochrane Reviews are prioritised and who is involved in setting
the review questions
2.1.5
Teaching activities
If relevant, please account for teaching activities of researchers at the centre over the last five years
2.1.6
Training activities
If relevant, please account for training activities at the centre over the last five years
2.1.7
Publication productivity
For the centre at large, please provide the average number of publications per researcher and the aver-
age number of publications per million of the budget for the last five years. Please use the information
on total publications in
Table 2.1
divided with the number of researchers from
Table 1.5
and the funding
from government grant and total funding in
Table 1.1.
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In the first table, please exclude publications, employees and budgets of Danish Cochrane Review
Groups affiliated with the centre
Table 2.3 Average number of publications per researcher and per million DKK (excluding publications, personnel
and budgets of Danish Cochrane Review Groups affiliated with the centre)
2014
Average number of publications
per employed researcher (FTE),
including management
Average number of publications
per 1 million DKK of government
grant
Average number of publications
per 1 million DKK of total funding
2015
2016
2017
2018
Please provide the same information for Danish Cochrane Review Groups affiliated with the centre,
based on the information on total publications in
Table 2.2,
the number of researchers from
Table 1.6
and the funding from government grant and total funding in
Table 1.2.
Table 2.4 Average number of publications per researcher and per million DKK for Danish Cochrane Review Groups
affiliated with the centre
2014
Average number of publications
per employed researcher (FTE),
including management
Average number of publications
per 1 million DKK of government
grant
Average number of publications
per 1 million DKK of total funding
2015
2016
2017
2018
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2.2
2.2.1
Research Quality
Journals of publication
Please provide a list of the peer-reviewed journals in which the centre’s researchers have published arti-
cles in the last five years and count the number of articles published in each of these journals for each
of the last five years in a table like the one below.
In the first table, please exclude publications of Danish Cochrane Review Groups affiliated with the cen-
tre
Table 2.5 Number of published peer-reviewed articles by journal (excluding publications of Danish Cochrane Re-
view Groups affiliated with the centre)
Journal name \ year
Journal 1 [name of journal]
Journal 2 [name of journal]
Journal N [name of journal]
Total number of peer-re-
viewed articles
2014
2015
2016
2017
2018
Total for
all years
Please describe which international journals you consider as the top journals for the centre’s research
and provide information on potential strategies underlying the distribution of articles in the table above
and/or for future publications in peer-reviewed journals.
Please provide the same information for publications by employees at Danish Cochrane Review Groups
affiliated with the centre
Table 2.6 Number of published peer-reviewed articles by employees at Danish Cochrane Review Groups affiliated
with the centre
Journal name \ year
Journal 1 [name of journal]
Journal 2 [name of journal]
Journal N [name of journal]
Total number of peer-re-
viewed articles
2014
2015
2016
2017
2018
Total for
all years
12
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2.2.2
Authorship order as indicator of involvement in research production
In health sciences, the first and last authorships are often considered the most prestigious. Please re-
flect whether this sort of reasoning is reflecting the way the authors are listed in the peer-reviewed arti-
cles published by your centre or other principles of authorship order are prominent.
2.3
2.3.1
PhD. activity
Phd Supervision responsibility
Please provide information whether the centre is expected to provide supervision for PhDs and if so,
how this supervision is provided
2.3.2
The number of PhD. projects that are initiated, ongoing, and defended dissertations
Please count the activity of PhDs for the last five years according to the three categories: PhDs that
have been initiated, PhDs that are ongoing and PhDs that are publicly defended (dissertations). Please
provide the number for each year in a table like the one below.
Table 2.7 PhD projects (excluding Danish Cochrane Review Groups affiliated with the centre)
Category \ year
PhDs initiated
PhDs ongoing
PhD Dissertations
Total
2014
2015
2016
2017
2018
Total
2.3.3
Affiliation of PhD fellows following the dissertation
Please provide the number of PhD fellows that are employed at the centre following the public defence
and PhDs that are no longer affiliated with the centre. This should be provided in table as the one be-
low. Please also provide a list of the specific affiliations of the PhDs that are not affiliated at the centre
after the PhD defence.
Table 2.8 Affiliation of PhD fellows (excluding Danish Cochrane Review Groups affiliated with the centre)
Category \ year
PhDs employed at the
centre following the de-
fence
PhDs employed other
places following the de-
fence
2014
2015
2016
2017
2018
Total
13
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Table 2.9 Employment of PhD fellows not affiliated with the centre after the Ph.D. defence (excluding Danish
Cochrane Review Groups affiliated with the centre)
Name of employment place following the public defence
14
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3 Impact and relevance
3.1.1
Who are the centre’s primary audiences/target groups in the Danish society?
Please list the organizations that the centre considers its primary target group.
3.1.2
Please describe the ways in which the centres’ research and activities are used by and creates
benefits in various parts of
the Danish society.
Include at least the following topics:
Examples of potential impact on clinical practices and clinical guidelines within the past
five years
Collaborations with public authorities within the past three years
Collaboration with hospitals and healthcare professionals within the past three years
Participation in consulting, commissions, boards etc. within the past three years
Organization of conferences, symposiums or other knowledge sharing initiatives within
the past three years
Other ways the centres’ research and activities are used by and creates benefits in the
Danish society within the past three years
For each of these topics please provide examples or documentation.
3.1.3
Visitors, secondments etc. at the centre in the past three years?
Please provide information on the number of visitors, secondments etc. at the centre in the past
three years.
3.1.4
Web hits, downloads of Cochrane reviews and media activity
Please provide information on
3.1.5
the number of web hits for your centre per year in the past three years
the number of Cochrane reviews, that have been downloaded by Danish IP-addresses
(.dk) in the past three years
the number of times employees at the centre have been cited in Danish media in the
past three years
User-friendly summaries of reviews and other tailored research knowledge
Please reflect upon the centre’s policy for making user-friendly summaries of reviews or other
tailored written versions of publications to communicate research knowledge to the primary tar-
get groups in the Danish society
3.1.6
The centre’s impact on the public debate in Denmark?
Please reflect upon the centre’s impact on the public debate in Denmark and give examples
15
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4 Collaborations and partnerships
4.1
4.1.1
National collaborations and partnerships
3
The centre’s formal collaborations and partnerships in Denmark
Please list the centre’s national collaborations during the last five years.
Please describe the role(s) of the centre in each of its national collaborations.
Please describe the achieved output of each of the national collaborations.
4.2
4.2.1
International collaborations and partnerships
The centre’s formal collaborations and partnerships internationally
Please list the centre’s international collaborations during the last five years
Please describe the role(s) of the centre in each of its international collaborations.
Please describe the achieved output of each of the international collaborations.
4.3
4.3.1
Own assessment of national and international collaborations
How does the centre’s collaborations cohere with the centre’s goals/vision and strategy?
Please reflect upon the importance of the centre’s collaborations for accomplishing the centre’s
goals/vision and for succeeding with its strategy.
Please reflect upon which areas of improvement you see, e.g. should the balance between na-
tional/international be changed; should output, focus, size of collaborations be different?
3
Collaborations and partnerships refer to arrangements where there is a formalized written agreement
on e.g. the content of the collaboration, the division of labor and the duration of the collaboration.
16
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Bilag 3
Evaluation Report Nordic Cochrane Cen-
tre
Dette bilag indeholder den evalueringsrapport, som det internationale evalueringspanel har
udarbejdet for det Nordiske Cochrane Center (NCC).
Ud over evalueringspanelets evaluering af det Nordiske Cochrane Center indeholder evalue-
ringsrapporten også panelets evalueringsperspektiver på de to danske Cochrane Review-
grupper, som er tættest knyttet til det Nordiske Cochrane Center:
The Colorectal Group (CCG),
The Anaesthesia Group and the Emergency and Critical Care Group (ACE).
35
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Evaluation of the Nordic Cochrane Centre
Final Report
Evalueringspanelets evalueringsrapport for Nordic Cochrane Centre
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Amanda Sowden
(Chair)
Professor and Deputy Director and leader of the University of York’s Centre for Reviews and Dissemination’s
research programme in public health, United Kingdom
Terje P. Hagen
(Co-chair)
Professor and Head at the Institute of Health and Society, University of Oslo, Norway
Diederick Grobbee
Professor of Clinical Epidemiology and founder of the Julius Center, University Medical Center Utrecht, The
Netherlands
Eva Swahn
Professor at the Department of Medical and Health Sciences, Division of Cardiology, Linköping University &
Department of Cardiology, University Hospital, Linköping, Sweden
Merete Osler
Clinical Professor at the Department of Public Health, University of Copenhagen & consultant at the Center for
Clinical Research and Prevention, Bispebjerg and Frederiksberg Hospital, Denmark
Mickael Bech
Professor in healthcare leadership at the Crown Prince Frederik Center for Public Leadership, Aarhus
University, Denmark
September 2019
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Table of Contents
Executive summary ............................................................................................ 1
Background of the evaluation ................................................................................. 1
Conclusions of the Evaluation Panel ...................................................................... 1
1
Introduction ............................................................................................... 3
1.1
1.2
1.3
1.4
1.5
Background ................................................................................................... 3
The evaluation .............................................................................................. 3
The evaluation panel .................................................................................... 4
Evaluation protocol ....................................................................................... 5
The evaluation process and methods ........................................................... 6
2
Management and organisation .................................................................. 7
2.1
2.2
2.3
2.4
2.5
Background, current position and funding .................................................... 7
Purpose and strategy .................................................................................... 8
Organisation and management .................................................................... 9
Governance arrangements ........................................................................... 9
The Panel’s assessment of the overall management and organisation ..... 10
3
Research production and quality ............................................................. 12
3.1
3.2
Research production and impact of publications ........................................ 12
The Panel’s overall assessment of research productivity and quality ........ 13
3.2 PhD supervision .............................................................................................. 13
4
Relevance and impact ............................................................................ 15
4.1
4.2
4.3
4.4
4.5
Primary audiences and target groups (stakeholders) ................................. 15
Setting priorities .......................................................................................... 15
Activities that lead to impact ....................................................................... 15
Contributions to public debate .................................................................... 16
The Panel’s overall assessment of relevance and impact.......................... 17
5
Collaborations and partnerships.............................................................. 18
5.1
5.2
5.3
Overview of national and international collaborations and partnerships .... 18
Cochrane partnerships ............................................................................... 18
The Panel’s overall assessment of collaborations and partnerships .......... 19
6
Options for organising Cochrane activities .............................................. 20
6.1
6.2
Summary of the evaluation ......................................................................... 20
Options ........................................................................................................ 20
7
Cochrane Review Groups (CRGs) .......................................................... 22
7.1
7.2
7.3
7.4
History and background .............................................................................. 22
Organizational arrangements ..................................................................... 23
Research production ................................................................................... 23
The Panel’s overall reflections on Cochrane Review Groups (CRGs) ....... 26
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Executive summary
Background of the evaluation
The Nordic Cochrane Centre (NCC) and the Copenhagen Trial Unit (CTU) receive funding from
the Ministry of Health via the National Finance Act. This funding has been in place since 1993
and, until now, no formal evaluation of the work of the Centres has taken place. Such an
evaluation was requested by the Ministry of Health and was organised and overseen by VIVE,
the Danish Center for Social Science Research. The aim of the evaluation was to assess
whether the purpose of the two centres as stated in the National Finance Act grant has been
fulfilled. The Finance Act states:
“The activities in the Cochrane area include preparation of systematic reviews of
health care interventions, prevention of diseases, diagnostics, treatment and care.
CTU supports and performs scientifically relevant clinical trials, i.a. as part of the
Cochrane Collaboration.”
(the National Finance Act 2018, translation by VIVE).
An international Panel of six people carried out the evaluation. The evaluation focused on i)
management and organisation of the centres; ii) research production and quality; iii) impact
and relevance of the centres’ activities and iv) collaborations and partnerships.
The results of the evaluation are presented in separate reports for each of the two centres. This
report presents the results of the evaluation of the NCC. The report also includes perspectives
on the Cochrane Anaesthesia, Cochrane Emergency and Critical Care and Cochrane
Colorectal Groups, which are also funded under the Finance Act.
Conclusions of the Evaluation Panel
The Panel concludes that the NCC’s overall purpose of informing health care decision-making
through the provision of high-quality synthesised evidence has been fulfilled. The Panel notes
the significant contribution made to improving the quality of evidence available to decision-
makers, including patients and the public. This has been achieved by developing robust
methods and advocating for their use through publication in high-impact journals and through
training. The NCC’s work is of clear relevance to Danish health care practices and there are
examples of significant influence on policy.
Some of the NCC’s work has received considerable media interest and has without doubt
informed public debate in Denmark and internationally. In turn, this is likely to bring benefits to
society by helping to drive science and clinical practice forward. Stakeholder feedback
suggests that the NCC has a good reputation, which is based on the quality, independence
and importance of its work and its anchoring to Cochrane’s overall mission. The Panel notes
the controversy surrounding some of the scientific and public debates, which have split the
opinions of policy-makers and the research community. The Panel see that there is a need for
increased engagement with stakeholders and to re-establish the Advisory Board, with a
refreshed membership, to include people engaged with the health policy and practice agenda
in Denmark.
Active collaboration with researchers nationally and internationally has resulted in high-quality
publications and outputs, notably reporting standards, Cochrane reviews, and clinical
1
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guidelines. By comparison, collaboration with the Denmark-based Cochrane Review Groups
(CRGs) appears to be very limited. Given the increasing complexity of Cochrane methods, the
need to adhere to methodological standards and editorial processes, and to ensure stakeholder
involvement in priority setting, the Panel concludes that the NCC and the Denmark-based
CRGs should develop closer working relationships, with opportunities for shared learning as a
priority.
Despite the NCC’s considerable achievements, the Panel questions the sustainability of its
current operating model, given its small size, dependence on Ministry funding, positioning in
Rigshospitalet and complex governance structures. The Panel concludes that there is an
urgent need to consider the options for a revised governance structure that would strengthen
the NCC’s current position and facilitate its future growth. Closer alignment with a university
would seem desirable, in bringing further potential for collaboration and increased opportunities
to secure research funding and recruit PhD students, as well as signalling its national scope,
while maintaining the research integrity and independence that is central to its operation and
strategy.
2
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1
1.1
Introduction
Background
The Ministry of Health has asked VIVE, The Danish Center for Social Science Research, to
evaluate the Nordic Cochrane Centre (NCC) and the Copenhagen Trial Unit (CTU).
The NCC and CTU receive a grant each year through the National Finance Act. In the National
Finance Act for 2018, it is stated:
”In 2018, DKK 17.8 million were allocated for financing of the Cochrane and
Copenhagen Trial Unit (CTU). The activities in the Cochrane area include
preparation of systematic reviews of health care interventions, prevention of
diseases, diagnostics, treatment and care. CTU supports and performs scientifically
relevant clinical trials, i.a. as part of the Cochrane Collaboration. The allocated funds
from 2009 onwards include DKK 0.5 million for the financing of free access for all to
the Cochrane Library”
(the National Finance Act 2018, translation by VIVE).
According to information from the centres, the 17.8 million DKK in 2018 were distributed as
follows:
The Nordic Cochrane Centre: 7,335,000 DKK
Copenhagen Trial Unit, including the Cochrane Hepato-Biliary Group: 7,735,000
The Cochrane Review Groups: 2,730,000 DKK
o
Herlev Hospital: 1.316.000 DKK (The Cochrane Anaesthesia and Cochrane
Emergency and Critical Care Groups)
o
Bispebjerg Hospital: 1,413,000 DKK (The Cochrane Colorectal Group).
1.2
The evaluation
The results of the evaluation are presented in separate reports for each of the two centres. This
report presents the results of the evaluation of the Nordic Cochrane Centre (NCC). In addition
to the NCC, the report includes perspectives on the Cochrane Anaesthesia and Cochrane
Emergency and Critical Care Groups and the Cochrane Colorectal Group.
The main aim of the evaluation is to assess whether the purpose of the National Finance Act
grant has been fulfilled, by evaluating the scale of research production and its quality as well
as the societal impact of the centres and their external collaborations and partnerships.
Accordingly, the evaluation includes both formative elements focusing on broadening the
understanding of the institute's characteristics for the purpose of continuous improvement and
summative elements focusing on accountability to the entity that funds the running of the
centre.
Specifically, the evaluation addresses the following four topics:
3
Evalueringspanelets evalueringsrapport for Nordic Cochrane Centre
Management and organisation of the centres
Research production and quality
Impact and relevance of the centres’ activities
Collaborations and partnerships.
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These topics are presented in further details below.
1.3
The evaluation panel
An international evaluation panel has carried out the evaluation and is responsible for writing
this report. The appointment of the chair of the evaluation panel was done by The Independent
Research Fund Denmark [Danish name: Danmarks Frie Forskningsfond, DFF] based on a
nomination by VIVE. VIVE appointed the additional members of the evaluation panel based on
nominations by DFF. VIVE requested DFF to nominate three internationally well-acknowledged
researchers from the medical sciences council under DFF and two researchers from the social
science council under DFF. The candidates from the medical sciences council were to have
insight into the processes and methods of randomised studies, systematic reviews and
experience with assessing the quality and impact of health care research. The candidates from
the social sciences council under DFF were to have insight into the Danish health care system
and management and organisation of health research. In order to ensure the impartiality of the
evaluation, a basic criterion in the nomination of candidates, in addition to the professional
skills, was that they must not have had collaborations or other close relations with the NCC,
CTU or their international counterparts in the last five years. DFF, in accordance with the
Danish Gender Equality Act, nominates at least one male and one female candidate for each
seat in the panel. After a process of nomination and invitation of nominees by DFF, VIVE
received a list from DFF of five researchers from the medical sciences council and two
researchers from the social sciences council, all of whom accepted the invitation. The
appointment of the additional members was done by VIVE, after consulting the chair of the
evaluation panel. Based on an overall assessment of the individual and complementary
qualifications, VIVE appointed three of the five researchers who accepted the invitation from
the medical sciences council and the two researchers that accepted the invitation from the
social sciences council. All panel members were appointed in their own personal capacity. The
composition of panel members has been subject to a hearing by the NCC and the CTU.
The panel consists of six members with complementary competencies in reviews in public
health, clinical research, trials and management, and organisation of health research:
Amanda Sowden (Chair). Professor and Deputy Director and leader of the University
of York’s Centre for Reviews and Dissemination’s research programme in public
health, United Kingdom
Terje P. Hagen (Co-chair). Professor and Head at the Institute of Health and Society,
University of Oslo, Norway
Diederick Grobbee. Professor of Clinical Epidemiology and founder of the Julius
Center, University Medical Center Utrecht, The Netherlands
Eva Swahn. Professor at the Department of Medical and Health Sciences, Division of
Cardiology, Linköping University & the Department of Cardiology, University Hospital,
Linköping, Sweden
Merete Osler. Clinical Professor at the Department of Public Health, University of
Copenhagen & consultant at the Center for Clinical Research and Prevention,
Bispebjerg and Frederiksberg Hospital, Denmark
Mickael Bech. Professor in healthcare leadership at Crown Prince Frederik Center for
Public Leadership, Aarhus University, Denmark.
4
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1.4
Evaluation protocol
The evaluation protocol elaborated by VIVE and the chair of the panel covers four topics:
Management and organisation
Research production and quality
Impact and relevance
Collaborations and partnerships.
The protocol contains the questions guiding the evaluation panel’s assessment and is
presented in further detail below.
Management and organisation
The evaluation panel was asked to give a general description and assessment of the
governance structure and the management and organizational structure of each of the two
centres. The description and assessment were to address the following:
An overall description and assessment of the governance structure of the centre,
including reflections on the governance structure’s ability to hold the management of
the centre accountable
A reflection on the strategy of the centre in relation to the purpose and mission of the
centre
A description and assessment of the management and organizational structure of the
centre, including reflections on the organizational and management structures’
adequacy for accomplishing the centre´s purpose and strategy, and the expediency of
the decision-making structure and the division of labour between the different sections
of the centre
An assessment of the organizational support for researchers
An assessment of the centre’s ability to attract external resources from research
councils, research funds, EU etc.
A reflection on the expediency of governance structure, the management and
organizational structure compared to similar types of institutions.
Research production and quality
The panel was asked to give an assessment of the quantity and quality of research from each
of the two centres. The assessment was to include the following elements:
A count of publications over the past five years divided into main types of publications
The average number of annual publications per researcher for the centre at large
An assessment of the quality of research based on bibliometric indicators
Reflections on the level and quality of output compared to economic resources
An assessment of the centres’ production of PhD candidates, including reflections on
the centres’ involvement in PhD programmes
An overall assessment of the productivity of the centre and the importance and quality
of the research.
5
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Impact and relevance
The evaluation panel was asked to give its assessment of the impact and relevance of each of
the two centres’ activities for the Danish society. The assessment was to include the following
elements:
An assessment of the impact of the centre on clinical practice and clinical guidelines.
Reflections on how the centres’ research and other activities create value in various
parts of the Danish society
Reflections on the centres’ impact on the public debate in Denmark
Collaborations and partnerships
The evaluation panel was asked to give its assessment of each of the two centre’s national
and international collaborations and partnerships. The assessment was to include the following
elements:
An assessment of the level of national and international collaboration of the centre,
including reflections on the level of national vs. international collaborations, and the
role of the centre in the collaborations
An assessment of the output of the collaborations
Reflections on importance of the collaboration for accomplishing the centre´s purpose
and strategy.
1.5
The evaluation process and methods
The evaluation of the two centres was carried out in parallel and is based on both quantitative
and qualitative data. The data include:
Self-evaluation reports by the NCC and CTU
Site-visit by the evaluation panel in Copenhagen 20
th
to 22
nd
May 2019
Documentation and additional data collected by VIVE
Both the self-evaluation reports, and the documentation and additional data collected by VIVE,
provide information on each of the four topics of the evaluation. The site-visit included meetings
with management, employees and a selected number of stakeholders of each centre as well
as a meeting with the management of the hosting organisation, The Danish National Hospital
– ‘Rigshospitalet’ and a teleconference with the Chief Executive Officer of Cochrane.
6
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2
Management and organisation
This section provides a brief overview of the history of the Nordic Cochrane Centre (NCC), its
current position and funding arrangements, its purpose and strategy, and its organizational and
governance structures.
2.1
Background, current position and funding
The NCC was established in 1993 by Professor Gøtzsche at Rigshospitalet in Copenhagen.
The international Cochrane Collaboration (now Cochrane) was itself founded in the same year.
Cochrane is an international organisation, with over 13,000 members from more than 130
countries, whose mission is to promote evidence-informed health decision-making by
producing high-quality, relevant and accessible systematic reviews and other forms of
synthesised research evidence.
The NCC was originally funded via the organisation Hovedstadens Sygehusfællesskab (HS:
The hospital community of the Capital Region). As part of the 2006 structural reforms in
Denmark, the organisation HS was merged into one of five regions, Capital Region of Denmark,
and the financial support for the NCC was transferred to the national Danish Finance Act, which
has continued to provide funding. In 2018, the amount of funding from the Danish Government
was DKK 7.335 million. Funding from other sources (e.g. research councils and research
funds) for 2018 amounted to DKK 0.71 million. In 2018, funding from the Danish Government
comprised 87% of the NCC’s total budget. In earlier years, this percentage ranged from 58
(2014) to 99 (2017).
Several Associate Centres have been set up, which are directly affiliated with the NCC. A
Norwegian Branch was established in 1997, and in 2017 Polish and Russian Branches were
established. Cochrane Finland was established in 1997, and Cochrane Sweden in 2017. In
addition, several Cochrane groups also refer to the NCC:
the Cochrane Hepato-biliary Group (DK)
the Cochrane Colorectal Group (DK)*
the Cochrane Anaesthesia Group (DK)*
the Cochrane Emergency and Critical Care Group (DK)*
the Occupational Health Group (Fin)
the Norwegian Satellite of the Effective Practice and Organization of Care Group (No)
the Cochrane Bias Methods Group (DK).
Three of these groups* are funded via the Danish Finance Act. In 2018, this funding amounted
to DKK 2.729 million, which is in addition to the funding for the NCC.
The NCC operates as a research department within Rigshospitalet, and all financial actions go
through the finance office and administrative issues through the Human Resources Department
at Rigshospitalet. Payments by the Danish Government are made directly to Rigshospitalet.
Funding for the three* Cochrane groups is administered by Herlev Hospital and Bispebjerg
Hospital, which host the editorial bases for these groups.
The NCC and the Copenhagen Trial Unit (CTU) are connected through their collective
government funding and are housed next door to each other at Rigshospitalet, but their
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activities are completely independent of each other. The CTU hosts the editorial base of the
Cochrane Hepato-Biliary Group, including its Co-ordinating and Managing Editors and
Information Specialist (see Evaluation of the Copenhagen Trial Unit – Report).
Also based at Rigshospitalet, and co-located with the NCC, is a small group who are part of
Cochrane’s Informatics and Technology Services. This service is centrally managed via the
Cochrane Central Executive team based in London, UK.
2.2
Purpose and strategy
The overall aim of the NCC is “to help citizens, patients, health care professionals and payers
of health care services to choose – or to avoid use of – interventions rationally, in an evidence-
based fashion, and with a focus on benefits, harms and costs.”
1
This aligns with Cochrane’s
Strategy to 2020
2
, which aims to put Cochrane evidence at the heart of health decision-making
all over the world and has the following goals:
1. Producing evidence –
to produce high-quality, relevant, up-to-date systematic reviews
and other synthesised research evidence to inform health decision-making.
2. Making our evidence accessible –
to make Cochrane evidence accessible and useful
to everybody, everywhere in the world.
3. Advocating for evidence –
to make Cochrane the ‘home of evidence’ to inform health
decision-making, build greater recognition of our work, and become the leading
advocate for evidence-informed health care.
4. Building an effective sustainable organisation –
to be a diverse, inclusive and
transparent international organisation that effectively harnesses the enthusiasm and
skills of our contributors, is guided by our principles, governed accountably, managed
efficiently and makes optimal use of its resources.
The NCC has five main areas of work, as set out in their
Strategic Plan 2016-2020:
1
1. Research
– priority is given to research that makes a difference to many people.
Specific areas of interest are psychiatric drugs and screening. Methodological research
that aims to elucidate the sources of bias is also a priority. Work will continue to improve
the reliability of clinical and observational studies and to develop and update reporting
guidelines.
2. Dissemination of research results
– priority is given to the translation of review
findings into understandable formats, including for patients and the public.
3. Associate centres and review groups
– the focus is on providing support to and close
working with affiliated centres and groups (currently in Denmark, Norway, Finland,
Sweden, Russia and Poland).
4. Partnerships
– priority is given to informal partnerships to ensure full academic
freedom.
5. Workshops and courses
– priority is given to supporting individuals in Denmark,
Sweden, Norway, Poland and Russia to complete Cochrane protocols and reviews.
1
2
Taken from
Strategic Plan 2016-2020: Nordic Cochrane Centre.
Taken from
Strategy to 2020 (Cochrane).
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2.3
Organisation and management
Full-time research positions are currently held by the Acting Director and a Senior Researcher.
In addition, the NCC employs a communications consultant, an administrator and a secretary,
plus four full-time PhD students and early career researchers, and two PhD students who are
shared with the Centre for Evidence-based Medicine (CEBMO) at the University of Southern
Denmark and Odense University Hospital. In addition, the Centre hosts visiting scholars and
students. NCC staff view their core strengths as being research synthesis and methodological
expertise.
In order to supervise PhD students and contribute to teaching, it is necessary for one or more
members of NCC staff to have a university affiliation. The PhD students are employed at the
NCC and they are enrolled in university PhD programmes. The former Director was affiliated
with the University of Copenhagen, through a Professorship and had the overall responsibility
for the NCC-funded PhD students. None of the NCC’s senior staff currently have a university
affiliation. Interim arrangements for the current PhD students are in place.
2.4
Governance arrangements
Cochrane
– The NCC holds the status of a ’Cochrane Centre’. Cochrane and the NCC have
signed a Collaboration Agreement which sets out the terms and conditions for both parties and
commits the NCC to support Cochrane’s mission, principles, organisational strategies and
goals, as defined by Cochrane’s Governing Board, and to fulfil the core functions of a Cochrane
Centre, as set out in
“Implementing Strategy to 2020: Cochrane Centres, Branches & Networks
– New functions and Structures”.
The Cochrane Governing Board is responsible for overseeing
the development and implementation of Cochrane’s strategic direction. The Acting Director of
the NCC is an elected member of the Cochrane Governing Board.
Cochrane Centres are directly accountable to the CEO of Cochrane to ensure adherence to
Cochrane’s overall strategy, and Centre Directors meet quarterly with Cochrane’s CEO to
review progress in relation to their own strategic plans.
3
Centres have coordinating
responsibility for national (and sometimes regional) work plans, and the NCC represents
Cochrane in the Nordic countries. The groups and affiliated centres in the Nordic Region report
directly to the NCC.
NCC
– The Centre is characterised by an informal culture, partly due to its small size, and
decisions about work plans are made in dialogue with individuals, rather than through formal
meetings or pre-allocation of resources based on full-time equivalents (FTEs). Prioritisation of
research activity is in line with the direction set out in the centre’s
Strategic Plan 2016-2020,
but ultimately it is the Director who decides which projects to initiate.
The NCC does not have a board of directors, as the Cochrane Governing Board sets the
agenda for the organisation overall. The NCC does have an advisory board; members are
consulted infrequently and on an ad hoc basis.
Danish Government
– The NCC is funded through the Danish Finance Act via the Ministry of
Health. The Danish Finance Act does not pose any requirements in terms of governance or
NCC’s Strategic plan 2015-2020 is available here - https://nordic.cochrane.org/strategic-
plan
3
9
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accountability. Since its inception in 1993, the NCC has not been formally evaluated, beyond
the monitoring of annual scientific and financial reports.
Rigshospitalet
– The NCC is hosted by Rigshospitalet and is organised as a hospital research
department. Rigshospitalet ensures formal rules and regulations are met, but no explicitly
defined governance structure is in place and the NCC is not accountable to Rigshospitalet for
its activities or decision-making.
University of Copenhagen
– The NCC had an affiliation with the University through the former
Director’s Professorship. The affiliation was a prerequisite for the centre to supervise PhD
students. None of the senior staff currently have affiliations with the University, and senior
researchers outside the NCC (with University affiliations) act as the main supervisors for
current PhD students.
2.5
The Panel’s assessment of the overall management and
organisation
The NCC’s overall purpose to inform health care decision-making through the provision of high-
quality synthesised evidence has been fulfilled. The Centre has made a significant contribution
to the quality of evidence available to decision-makers, including patients and the public, by
developing robust methods and advocating for their use through publication in prestigious
journals and through training.
Given the small size of the NCC, its achievements are impressive. Currently, there are two
senior researchers to develop, lead, oversee and manage the work of the Centre and its staff.
The Panel noted that due to its positioning in Rigshospitalet, the NCC appears to be relatively
isolated from the academic community and this, coupled with its small size, may be
disadvantageous for PhD students and early career researchers, who appear to have limited
opportunities to engage in wider academic pursuits or for career development. Although, it is
noted that PhD students can visit Cochrane Centres and partnering research units in other
countries. PhD students are formally enrolled at the University of Copenhagen, but there seem
to be few interactions with other academic environments. The Panel suggests that a more
formal affiliation with the University of Copenhagen, and/or with the CEBMO at the University
of Southern Denmark, would enhance possibilities for collaboration and joint working. The
Panel notes that Cochrane Centres in other countries are often based in or affiliated with
Universities and therefore benefit from wider academic engagement and collaboration.
The Panel notes that the NCC is almost exclusively dependent on funding from the Danish
Ministry, which could threaten its future sustainability – particularly if, at any point, this grant is
reduced or removed. Additional research grants have been secured, but for relatively small
amounts compared with the Ministry funding. The success in attracting external funding seems
to vary, and the NCC does not appear to have a strategy for actively pursuing research income.
The NCC’s governance arrangements appear intricate, with differing levels of accountability to
Cochrane, Rigshospitalet and the Ministry of Health. The NCC’s affiliation to the University of
Copenhagen (via a Professorship) creates an additional complexity. The Panel’s impression
was one of a somewhat vague governance structure, lacking in accountability and with weak
organisational anchoring. The NCC is answerable to Rigshospitalet for the legal use of the
government grant, but no formal evaluation of its work and activities has been made beyond
the annual monitoring of accounts and scientific outputs. Discussions have taken place
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between the Chief Executive Officer (CEO) of Cochrane and the Acting Director of the NCC
about the governance structure, and both acknowledged that clear lines of accountability and
regular communication are important and necessary. In a meeting with the Panel,
Rigshospitalet highlighted the importance of a clear and strong governance structure, while
noting the need for a Cochrane Centre to be an independent entity, which led them to conclude
that an alternative governance structure was needed.
Although the NCC has an advisory board, the Panel felt that the full potential of this group to
influence and shape the Centre’s activities has not been realised. The Panel questioned
whether the membership of the advisory board was sufficiently close to, and engaged with, the
health policy and practice agenda, in Denmark, and whether membership could be refreshed.
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3
Research production and quality
This section provides an overview and assessment of the research production and quality.
Various bibliometric indicators were used to inform the assessment. The indicators capture the
involvement and productivity of the NCC in any of the peer-reviewed publications, as well as
the performance of the publications. The analyses are restricted to publications from 2012/14
to 2018 and include only publications indexed in the Web of Science (WoS) database.
This section also includes an overview of the NCC’s involvement in PhD supervision.
3.1
Research production and impact of publications
From 2014 to 2018, the NCC has registered 140 publications, of which 55 (39% of total
publications) are journal articles and 18 (12% of total publications) are Cochrane articles (Table
3.1).
Table 3.1 Number and publication classification of the publications from NCC
WoS -Classification
2012
No.
Article
Cochrane
Editorial
Letter
Review
Total
20
2
1
6
4
33
2013
No.
12
6
3
16
5
42
2014
No.
21
6
2
5
4
38
2015
No.
10
4
2
14
3
33
2016
No.
10
5
3
9
6
33
2017
No.
8
3
0
5
5
21
2018
No.
6
0
3
4
2
15
2014-2018
Total
No.
55
18
10
37
20
140
2012-2018
Total
No.
87
26
14
59
29
215
Abbreviations: WoS: Web of Science, No.: Number of observations.
Des:
The table shows the NCC’s publications from 2012 to 2018, divided into the five publication categories used in the
analysis.
Between 2014 and 2018, NCC staff had 60 (43% of total publications) first authorships, 77
(55% of total publications) last authorships and 51 co-authorships (data not shown in tables).
Comparing the citations received by the publications to those of the average article published
in the field of clinical medicine, publications from the NCC received 2.93 times more citations
than the average publication (MNCS Clinical Medicine range 1.71 to 3.62, for individual years).
A similar result is found when the NCC publications are compared to an average publication in
all the WoS fields. NCC publications receive 2.88 times more citations than the average article
in all WoS fields (MNCS All fields range from 1.68 to 2.64, for individual years; Table 3.2).
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Table 3.2 Number of citations and normalised citation score for publications from the
NCC
Number
TC
Mean TC
Median
TC
5.5
5
4
3
2
4
Max TC
MNCS
Clinical
Medicine
3.62
3.22
1.71
2.46
3.54
2.93
MNCS All
fields
3.64
3.25
1.68
2.30
3.27
2.88
Missing
Publi-
cations
0
6
4
3
0
13
2014
2015
2016
2017
2018
All years
38
27
29
18
15
127
1603
765
298
112
38
2816
42.18
28.33
10.28
6.22
2.53
22.17
608
571
66
42
7
608
Abbreviations: TC: Total number of citations for the period, MNCS: mean normalised citations score of the publications of a
unit
Des:
The table shows the number of publications included in the analysis. For each publication year, the total, mean,
median and maximum number of citations of the publications in that year are shown. The table further shows the
mean MNCS Clinical medicine and MNCS All fields scores, which indicate whether the publications received more
(scored above 1) or fewer (scored less than 1) citations than the average publications in the relevant field in the given
publication year. It was not possible to obtain citation data for all the NCC publications, for which reason there are
missing data. The most frequent missing publication type is Cochrane protocols.
Note: We apply weights based on the publication’s classification for both MNCS scores. Articles, Cochrane articles and
reviews are given a weight of 1 in the analysis, whereas letters, comments and editorials are given a weight of 0.25
When focusing on articles from the two publication categories ‘articles’ and ‘Cochrane articles
(excluding reviews, letters and editorials)’, there are 69 publications, which on average have a
MNCS Clinical Medicine score of 4.5 (MNCS Clinical Medicine range 2.81 to 5.73, for individual
years) and a MNCS All fields score of 4.44 (MNCS All fields range 2.75 to 5.77, for individual
years). Both results imply that the publications from the NCC receive more than twice as many
citations as an average publication in the two fields of WoS. The MNCS scores are slightly
higher than the scores obtained using all publications categories, which might be explained by
the exclusion of letters and editorials, which do not receive many citations.
3.2 PhD supervision
The NCC considers PhD supervision and mentoring to be a necessary obligation of any
research centre. In their self-evaluation report, the NCC recorded seven PhD students as being
registered in the period 2014-18. In the same period, one PhD Fellow was employed by the
NCC following their defence.
3.2
The Panel’s overall assessment of research productivity and
quality
The Panel concluded that the NCC has produced an impressive number of outputs, with many
judged to be of high quality, as evidenced by publication in high-impact journals, including
BMJ,
Lancet, Ann Intern Med, JAMA,
and
J Clin Epidemiol.
Based on the number of employees at
the NCC (FTE), ranging between 2.4 and 2.77 over the five-year period, this equates to
approximately 20 outputs (all) per year, per researcher (FTE), or approximately five peer-
reviewed journal articles per year, per researcher (FTE).
Many of the publications report methodological research, with the aim of expanding existing,
or developing new, approaches and methods for systematic review – for example, the inclusion
of clinical study reports from drug regulatory authorities. Publications include major reporting
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guidelines, such as CONSORT for randomised trials and PRISMA for systematic reviews,
developed as part of international collaborations. The NCC has played an important role in
developing the methods that underpin research synthesis and this is notably one of their main
strengths, as well as being a central aim of their overall strategy.
Of the 17 Cochrane reviews in production over the past five years, five are judged by the NCC
as being ‘complex’. Reviews are considered complex if they differ from standard systematic
reviews in terms of the nature and sources of data and the processes used for synthesis and
interpretation. These reviews often require a multidisciplinary review team with a particular skill
set, especially highly skilled methodological and statistical expertise.
Although the NCC does not have a specific remit to supervise PhD students, the importance
of doctoral research and students was highlighted. Over the five-year period, seven PhD
students were registered. In addition, staff contributed to PhD training at the University of Lund
in Sweden and to courses in evidence-based medicine at the University of Copenhagen, as
well as to workshops and events in Denmark and beyond. The Panel agreed that the NCC
potentially had more to offer with regard to boosting systematic review capacity, through
increased supervision of PhD students.
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4
Relevance and impact
This section describes and assesses the relevance and impact of the NCC’s activities in the
context of Cochrane’s overall mission as an international organisation, whose combined
activities have a worldwide focus, which benefits many countries. As such, Danish society
benefits from Cochrane activities carried out in other countries, not just those undertaken in
Denmark.
4.1
Primary audiences and target groups (stakeholders)
The NCC’s primary audiences and target groups include patients, carers and their families;
health professionals; policy-makers and other decision-makers; and researchers and
academics, guideline producers, journalists, professional societies and librarians. Within
Cochrane itself, Danish authors and editors, and affiliated entities, are key target groups.
4.2
Setting priorities
Working with stakeholders to set priorities for systematic reviews is essential; not only to ensure
that important questions are addressed, but also to provide a foundation for knowledge
translation. The NCC’s overarching aim is to work in areas that affect many people, because
this is where research can have the most value. The NCC states that their research agenda is
set locally and developed with national and international collaborators. Examples of systematic
reviews that have addressed important questions with national and international relevance
include:
Screening for breast cancer with mammography. This review was requested by the
Danish Ministry of Health and has been updated regularly, most recently in 2013.
https://www.cochranelibrary.com/cdsr/doi/10.1002/14651858.CD001877.pub5/full
Treatment for women with post-partum iron deficiency anaemia. This review was
undertaken with Danish clinicians, who identified a clinically important question. Most
recent update; 2015.
https://www.cochranelibrary.com/cdsr/doi/10.1002/14651858.CD010861.pub2/full
General health checks in adults for reducing morbidity and mortality from disease. This
review was undertaken because of its potential societal impact, and the findings were
discussed with the Danish Minister of Health. Most recent update: 2019.
https://www.cochranelibrary.com/cdsr/doi/10.1002/14651858.CD009009.pub3/full
Screening for reducing morbidity and mortality in malignant melanoma. This review
was initiated because of its potential societal impact. Published in June 2019.
https://www.cochranelibrary.com/cdsr/doi/10.1002/14651858.CD012352.pub2/full
4.3
Activities that lead to impact
The NCC has been active in a range of activities that are considered important in achieving
impact (‘pathway to impact’). These activities include advocating for better quality evidence;
making evidence accessible to Danish audiences (now coordinated by a communications
consultant); promoting the use of evidence in decision-making; and working with public
authorities to develop clinical guidelines, using the best available research evidence. National
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and international guidelines can have a direct impact on healthcare practices and affect the
lives of thousands of patients. Recent examples of NCC involvement in the development of
national clinical guidelines include:
The national clinical guidelines project initiated by the Danish Health Authority (2014).
The NCC was instrumental in developing the underpinning methodology.
Physiotherapy and Ergotherapy for Children with Cerebral Palsy, March 2014.
National Clinical Guideline for Rehabilitation in patients with COPD, May 2014.
National Clinical Guideline for Treatment of ADHD in Adults, February 2015.
National Clinical Guideline for Treatment of Cervical Radiculopathy, May 2015.
National Clinical Guideline for Non-pharmacological Interventions for Depression, May
2016.
National Clinical Guideline for Surgical Interventions for Obesity, January 2017.
In addition, the NCC has played a key role in developing and promoting the methods of
evidence-based medicine in Denmark and beyond. International collaborations have resulted
in reporting guidelines, including the CONSORT statement for randomised trials; STROBE for
observational studies; PRISMA for systematic reviews and SPIRIT for study protocols, which
are used globally. Of particular note is the work to gain access to clinical study reports from the
European Medicines Agency, which led to full disclosure of clinical trial data in Europe. The
next step is to explore the inclusion of study reports in systematic reviews, and this is a priority
for Cochrane.
4.4
Contributions to public debate
The NCC reports that they receive frequent requests to evaluate the quality of the evidence on
a specific research topic, and this is related to their reputation of independence. They view this
as an important contribution to advancing the call for better evidence to inform decision-making
and to improve health information for the general public. The NCC gives several examples:
In 2017, the NCC was requested by journalists from the Danish Broadcasting
Corporation to evaluate the evidence behind the promotional claim that the pain
medications Tramadol and Tapentadol were rarely addictive. This resulted in a series
of TV documentaries, which were reported on national TV news. The TV programmes
raised awareness about opioid use in Denmark and led to new regulations ensuring
that both Tramadol and Tapentadol were regulated in the same way as other opioids.
The Danish Ministry produced a new report on adverse reactions to Tramadol, and
recent data show that the use of Tramadol has fallen.
In 2018, the NCC was requested to review the evidence for the effectiveness of an
intervention for childhood obesity, which resulted in articles in a national newspaper
about the drug’s limitations.
The NCC’s research on screening, particularly mammography screening, has informed
public policy and debate over many years. This has initiated an intense debate
between the NCC and the Danish Cancer Society and, although opinions have been
diverse, it is plausible that the debate will help drive science forward and encourage
more investigation of the beneficial effects and potential harms of screening. This work
has also had impact outside Denmark, most notably in France and Switzerland, with
both countries re-evaluating their recommendations on mammography screening.
More generally, the NCC has advocated for transparency and better documentation
on the efficacy and safety of healthcare interventions and conflicts of interest. This has
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contributed to new regulations governing postgraduate training of doctors in
collaboration with the pharmaceutical industry, and rules for conflicts of interest among
members of the Medical Council. The NCC’s agenda on this has been articulated in
Danish medical journals and major newspapers (see, for instance:
http://ugeskriftet.dk/debat/laegemiddelstyrelsen-og-laegemiddelindustrien-ligner-et-
lukket-kredsloeb,
https://finans.dk/erhverv/ECE11496437/chefer-i-laegemiddelstyrelsen-ejer-aktier-i-
novo-nordisk-nu-skal-det-stoppes/?ctxref=forside
https://laegemiddelstyrelsen.dk/en/news/2019/danish-medicines-agency-strengthens-
its-policy-on-conflicts-of-interest/).
4.5
The Panel’s overall assessment of relevance and impact
The NCC’s work is of clear relevance to Danish health care practice and policy, and there are
examples of significant influence on policy. These include the Centre’s contributions to national
clinical guidelines covering a range of topics, such as depression and obesity, plus the Centre’s
work on general health checks, which influenced the Government’s decision not to introduce
them. The findings from this review have been promoted internationally, and their implications
are being discussed in other countries, including the UK.
As noted in Section 4.4, some of the NCC’s work has received considerable media interest and
widespread coverage and has without doubt informed public debate in Denmark and beyond.
In turn, this is likely to bring benefits to society by helping to drive science and practice forward.
Public opinion on some of the NCC’s work has been diverse, and the depth of feeling has been
played out in the public domain, leading the Panel to question whether this has been potentially
detrimental to the organisations involved and the role of the NCC’s governing structures.
Stakeholder feedback suggests that the NCC has a good reputation, largely due to the quality,
independence and importance of its work and to the central mission of Cochrane. There was
strong support for re-establishing the Advisory Board, and for increased engagement with
stakeholders, to help determine research priorities. The Panel concurred that having stronger
stakeholder engagement and a refreshed Advisory Board would be beneficial.
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5
Collaborations and partnerships
This section provides a short overview of the NCC’s collaborations and partnerships with other
organisations, together with the Panel’s reflections on these, and of the NCC as a
representative of Cochrane entities in the Nordic countries and as a contributor to the
international Cochrane organisation.
The Panel notes that the NCC states that they are independent of any political interests and
institutions, and have full academic freedom. This underpins their approach to collaboration
and partnerships outside of Cochrane.
5.1
Overview of national and international collaborations and
partnerships
The NCC has highlighted three national partners: the Danish Health Authority; the Centre for
Evidence-based Medicine Odense (CEBMO) and the Section for General Practice at the
University of Copenhagen.
Collaboration with the Danish Health Authority is long-standing and focuses on the production
of national clinical guidelines, where NCC staff have served as methods consultants and
contributed to national screening committees. Collaborations with researchers based in the
CEBMO and the Section for General Practice at the University of Copenhagen involve
supervision and mentoring of PhD students, as well as joint working on individual projects,
particularly on bias in research, the impact of conflicts of interest and screening.
The NCC has highlighted its collaboration with the international
Preventing Overdiagnosis
initiative. This initiative supports the development of a community of clinicians, researchers,
policy-makers and citizen advocates with an interest in overdiagnosis, organises international
conferences and encourages the generation of research. The NCC is leading a project
involving 30 researchers from institutions worldwide to develop an evidence-based approach
to re-evaluation of existing screening interventions. This aligns closely with the NCC’s ongoing
interests in screening.
NCC staff are currently exploring options to contribute to EVIPNet, a network established by
WHO to promote the systematic use of research evidence in health policy-making across
Europe.
Evidence presented in other sections of this report is relevant here, as many of the
achievements highlighted are dependent on successful collaboration.
5.2
Cochrane partnerships
The NCC serves as the local representative for Cochrane in Denmark and in the countries
where affiliated centres or groups exist. Staff from the NCC and Cochrane Sweden contribute
to PhD training in systematic reviews at the University of Lund, and these courses are available
to Danish PhD students. Workshops in systematic reviews are provided by NCC staff to
affiliated centres in Sweden, Norway, Poland and Russia. All Denmark-based Cochrane
Review Groups (CRGs) are invited to research meetings at the NCC.
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NCC staff worked with the Cochrane Editorial Unit in London to establish new coordinating
editors for two of the CRGs based in Denmark: Cochrane Colorectal Group and Cochrane
Anaesthesia, Critical and Emergency Care Group.
5.3
The Panel’s overall assessment of collaborations and
partnerships
The NCC has actively engaged in developing collaborations and partnerships within Denmark,
the other Nordic countries and internationally. These have mainly been with individual
researchers, as opposed to wider organizational collaborations. Collaborations have resulted
in high-quality research and publications, notably reporting standards, Cochrane reviews,
methodological development and other important outputs, such as clinical guidelines.
The NCC contributes to a range of Cochrane training activities, notably with Cochrane Sweden.
The Panel agreed that the NCC potentially had more to offer with regard to enhancing
systematic review capacity in Denmark and other Nordic countries, but that the relatively small
number of senior staff might be a restricting factor.
Collaboration with the CRGs based in Denmark appears to be limited, with the exception of the
Cochrane Bias Methods Group where a range of activities are ongoing, including joint
supervision of PhD students. The Panel noted that the CRGs appear to work independently of
the NCC and of each other. The NCC expressed their desire to the Panel to re-introduce regular
meetings with the CRGs and to establish closer working relationships. The Panel concurred
that stronger collaborations between the NCC and the Denmark-based CRGs would be
beneficial. In light of the increasing complexity of Cochrane methods, and the need to adhere
to methodological standards, opportunities for support and shared learning should be actively
pursued.
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6
6.1
Options for organising Cochrane activities
Summary of the evaluation
The Panel concluded that the NCC has achieved its main aims and objectives: it has i)
contributed to the overall goals of Cochrane; ii) pursued the activities outlined in its own
strategic plan (2016-2020) and iii) met the objectives set out in the contract with the Ministry of
Health (“The
activities in the Cochrane area include preparation of systematic reviews of health
care interventions, prevention of diseases, diagnostics, treatment and care”).
However, given
the lack of specificity in the contract with the Ministry, it is challenging for the Panel to make
precise assessments regarding the degree to which the NCC is meeting the expectations of its
core funding.
In considering the value of core funding, the Panel agreed that it provides a platform to:
Support and co-ordinate Cochrane activities in Denmark and other Nordic countries
Promote the work of Cochrane and the NCC and the value of evidence-informed
health-care
Engage with policy-makers, practitioners, patients and other stakeholders to identify,
define and address important research priorities in Denmark
Undertake high-quality, impactful research, underpinned by longer-term
methodological development
Build research capacity and expertise, and provide a unique source of advice and
bespoke training
Generate additional research income that expands the work of the Centre and
contributes to future sustainability.
Despite the NCC’s considerable achievements, the panel questions the viability of its current
operating model:
The NCC is small in size and seems isolated, given its positioning in Rigshospitalet.
These limitations might affect the NCC’s ability to secure additional research funding,
which is necessary to foster growth and reduce dependency on the ministry grant. An
organisational affiliation that facilitates collaboration beyond the local academic
community should increase opportunities as well as bringing other benefits, especially
for early career researchers.
The NCC’s governing structure is complex and lacks clear lines of accountability. A
clearer governance structure should improve the transparency of decision-making and
clarify to whom and how the NCC is accountable for its national grant and activities. In
light of Rigshospitalet’s steer to the Panel that an alternative governance structure is
needed, clarification around future arrangements requires urgent consideration.
6.2
Options
The Panel concludes that there is a need to consider the options that would strengthen the
NCC’s current position and facilitate its future growth. Closer alignment with a university would
seem desirable, bringing further potential for collaboration, and increased opportunities to
secure research funding and recruit PhD students.
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Option 1
– The NCC was previously affiliated with the University of Copenhagen (through its
Professorship) and hosts several PhD students enrolled at the University of Copenhagen. One
option is to align the NCC within a cognate Department or Faculty at the University of
Copenhagen to provide potential synergy. The national funding from the Finance Act would be
an earmarked grant to the University, which would allow Cochrane activities to continue at the
current level. This could be supplemented by research grants and possible investment from
the University to foster growth, which should improve academic sustainability while maintaining
the research integrity and independence that is central to the NCC’s operation and strategy.
Option 2
– The NCC works collaboratively with the Centre for Evidence-based Medicine
Odense (CEBMO) at the University of Southern Denmark, through joint supervision of PhD
students and via the Cochrane Bias Methods Group. Another option would be to align NCC
with existing research groups working in the area of evidence-based medicine or in the National
Institute of Public Health at the University of Southern Denmark. As outlined in Option 1,
funding would be from an earmarked grant from the Ministry, which could be supplemented by
research grants and possible investment from the University of Southern Denmark. Again, this
should improve academic sustainability while maintaining the research integrity and
independence that is central to the NCCs operation and strategy.
Given existing collaborations, either option seems viable, and both options would offer
opportunities to build critical mass and for cross-fertilisation of ideas with researchers working
in cognate areas. Either option would signal the national scope of the NCC, which, given its
funding source, is important. Similar arrangements are in place in other countries.
4
4
See VIVE supplementary data and materials: The Nordic Cochrane Centre.
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7
Cochrane Review Groups (CRGs)
This section provides a short overview of the history of the CRGs funded under the grant from
the Ministry of Health, their organizational arrangements (including links with the NCC),
research productivity and the Panel’s overall reflections.
7.1
History and background
Three Cochrane review groups, based in Copenhagen, are funded via the grant from the
Ministry of Health. These are:
1. The Colorectal Group
The Colorectal Cancer Group was registered as a Cochrane Review group in 1998. The
coordinating editor of this group is Jacob Rosenberg, Professor and Director of the
Center for Perioperative Optimizaton (CPO) at Herlev Hospital in the greater
Copenhagen area. Rosenberg was appointed coordinating editor in 2018 and is
currently working on re-establishing an infrastructure and new strategic direction for the
group.5 The group is now known as the Cochrane Colorectal Group (CCG).
2. The Anaesthesia Group and the Emergency and Critical Care Group (one group
until 2018)
The Anaesthesia, Critical and Emergency Care Group was established in 2000 at
Bispebjerg Hospital, in Copenhagen.6 Since 2014, the Group has been based at Herlev
Hospital in Copenhagen. Professor Ann Merete Møller has been Coordinating Editor of
both groups for 20 years, until 2018. Now, Andrew Smith from the Royal Lancaster
Infirmary, UK, is the coordinating editor of the Anaesthesia Group and Harald Herkner,
Medical University of Vienna, Austria, is coordinating editor of the Emergency and
Critical Care Group. Both groups are affiliated with the anaesthetic research unit at
Herlev Hospital, Capital Region, Denmark. For the purposes of this report, the two
groups will be considered as a whole (ACE).
3. The Cochrane Hepato-Biliary Group
The Cochrane Hepato-Biliary Group was formed in 1996, and the coordinating editor is
Christian Gluud, director of the Copenhagen Trials Unit (CTU) in Copenhagen. This
Group is discussed in more detail in the Evaluation Report for the CTU.
5
6
Further details about the history of the Colorectal Group can be found on the Cochrane website:
https://colorectal.cochrane.org/more-about-us
Further details about the Anaesthesia Group and the Cochrane Emergency and Critical Care Groups can be found on the
Cochrane website: https://community.cochrane.org/news/news-cochrane-anaesthesia-critical-and-emergency-care-
group
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7.2
Organizational arrangements
The financial accounting for the Colorectal Group (CCG), the Anaesthesia Group and the
Emergency and Critical Care Group (ACE) takes place at the host hospitals:
The Cochrane Review Groups: TOTAL 2,730,000 DKK per year
o
ACE: 1,316,000 DKK
o
CCG: 1,413,000 DKK
ACE: the managing editor, information specialist and administrative co-ordinator (0.2 full-time
equivalent) are paid directly from the Danish Ministry grant. Editors and reviewers contribute
on a voluntary basis.
CCG: the managing editor and administrative co-ordinator are paid directly from the Danish
Ministry grant. Editors and reviewers contribute on a voluntary basis. A few non-profit
organisations have provided funds over the past ten years.
The remit of these groups is to prepare and update Cochrane reviews. Review production is
managed within each group by co-ordinating and managing editors. In 2018, Cochrane
implemented its ‘CRG Transformation Programme’ with the aim of creating a more sustainable
review production system.
7
The Programme introduced Cochrane networks and new
governance structures for CRGs. Each CRG is nested within one of eight networks and the
networks are led by a Senior Editor. The CRGs work with their Senior Editor to ensure
consistent quality of reviews and efficient editorial processes. CRGs are accountable to the
editor-in-chief of the Cochrane Library via their senior editor. Each CRG is required to sign a
Memorandum of Understanding, every five years, with the editor-in-chief, which describes the
expectations and responsibilities of Cochrane and the CRG. Senior Editors and the editor-in-
chief are responsible for ensuring that accountability is aligned with any requirements of the
funder.
7.3
CCG
Research production
From 2014 to 2018, the CCG registered 56 publications, of which 54 (96% of total publications)
are Cochrane articles and two (4% of total publications) are reviews (Table 7.1). There was no
information on 22 (39% of total publications) publications from 2014 to 2018 in WoS databases
(mostly Cochrane protocols).
7
Further details are available at: https://community.cochrane.org/organizational-info/resources/resources-groups/crg-
networks-portal/crg-network-resources
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Table 7.1
Number and publication classification of the publications from CCG
2012
No.
2013
No.
0
14
0
0
0
14
2014
No.
0
4
0
0
0
4
2015
No.
0
7
0
0
0
7
2016
No.
0
14
0
0
0
14
2017
No.
0
16
0
0
2
18
2018
No.
0
13
0
0
0
13
2014-2018
Total
No.
0
54
0
0
2
56
2012-2018
Total
No.
0
101
0
0
2
103
WoS -Classification
Article
Cochrane
Editorial
Letter
Review
Total
0
33
0
0
0
33
Abbreviations: WoS: Web of Science, No.: Number of observations.
Des:
The table shows CCG’s publications from 2012 to 2018, divided into the five publication categories used in the
analysis.
The 34 publications by CCG gained 253 citations from 2014 to 2018. Most citations were for
articles published in 2014 and 2015, which is expected as articles from those years have had
longer exposure time than articles published in 2017 or 2018. The average article received
seven citations for all years (Mean TC range is 0 to 47, for individual years).
Table 7.2 Number of citations and normalised citation score for publications from
CCG
Numb
er
2014
2015
2016
2017
2018
All
years
2
4
4
14
10
34
TC
94
53
42
63
1
25
3
Mean
TC
47
13
11
5
0
7
Median
TC
47
15
8
2
0
2
Max
TC
52
19
20
31
1
52
MNCS Clinical
Medicine
4.08
1.52
1.93
1.83
0.20
1.46
MNCS All
fields
4.10
1.53
1.89
1.71
0.19
1.40
Missing
Publications
2
3
10
4
3
22
Abbreviations: TC: Total number of citations for the period, MNCS: Mean Normalised Citations Score of the publications of a
unit.
Des:
The table shows the number of publications included in the analysis. For each publication year, the total, mean,
median and max. number of citations the publications in that year are shown. The table further shows the mean
MNCS Clinical medicine and MNCS All fields scores, which indicate whether the publications received more (scored
above 1) or fewer (scored less than 1) citations than the average publication in the relevant field in the given
publication year. It was not possible to obtain citation data for all the CCG publications, for which reason there are
missing data. The most frequent missing publication type is Cochrane protocols.
Note: We apply weights based on the publication’s classification for both MNCS scores. Articles, Cochrane articles and
reviews are given a weight of 1 in the analysis, whereas letters, comments and editorials are given a weight of 0.25.
When comparing the citations received by the 34 publications to those of the average article
published in the field of clinical medicine, publications from CCG received 1.46 times more
citations than the average publication in the field of clinical medicine (MNCS Clinical Medicine
range is 0.20 to 4.08, for individual years). In other words, they received more citations than an
average publication in the field. Similarly, when CCG publications are compared to an average
publication in all the WoS fields, the CCG publications received 1.40 times more citations than
the average article in all WoS fields (MNCS All fields range is 0.19 to 4.10, for individual years,
see Table 7.2).
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ACE
From 2014 to 2018, ACE registered 399 publications, of which 160 (40% of total publications)
are journal articles and 231(58% of total publications) are Cochrane articles (Table 7.3). There
was no information on 42 (10% of total publications) publications from 2014 to 2018 in WoS
databases (mostly Cochrane protocols).
Table 7.3 Number and publication classification of the publications from ACE
WoS -Classification
2012
No.
Article
Cochrane
Editorial
Letter
Review
Total
11
18
0
0
1
30
2013
No.
5
30
1
0
1
37
2014
No.
24
44
0
0
1
69
2015
No.
27
48
0
0
0
75
2016
No.
34
61
1
0
1
97
2017
No.
35
39
0
0
1
75
2018
No.
40
39
0
0
4
83
2014-2018
Total
No.
160
231
1
0
7
399
2012-2018
Total
No.
176
279
2
0
9
466
Abbreviations: WoS: Web of Science, No.: Number of observations.
Des:
The table shows ACE’s publications from 2012 to 2018, divided into the five publication categories used in the
analysis.
Note: There are an unknown number of reviews in the Article category.
The 357 publications by ACE gained 3,846 citations from 2014 to 2018 (Table 7.4). Most
citations were for articles published in 2014 and 2015, which is expected as articles from those
years have had a longer exposure time than articles published in 2017 or 2018. The average
article received 10.77 for all years (Mean TC range is 1.04 to 21.13, for individual years).
Table 7.4 Number of citations and normalised citation score for publications from
ACE
Number
TC
Mean TC
Median
TC
12
11
6
2
0
4
Max TC
MNCS
Clinical
Medicine
1.84
1.92
1.76
2.57
2.12
2.02
MNCS All
fields
1.85
1.94
1.72
2.40
1.96
1.95
Missing
Publica-
tions
1
7
13
14
7
42
2014
2015
2016
2017
2018
All years
68
68
84
61
76
357
1,437
1,137
808
385
79
3,846
21.13
16.72
9.62
6.31
1.04
10.77
140
120
51
68
7
140
Abbreviations: TC: Total number of citations for the period, MNCS: Mean Normalised Citations Score of the publications of a
unit.
Des:
The table shows the number of publications included in the analyses. For each publication year, the total, mean,
median and maximum number of citations in the publications in that year are shown. The table further shows the
mean MNCS Clinical medicine and MNCS All fields score, which indicate whether the publications received more
(score above 1) or fewer (score less than 1) citations than the average publication in the relevant field in the given
publication year. It was not possible to obtain citation data for all the ACE’s publications, for which reason there are
missing data. The most frequent missing publication type is Cochrane protocols.
Note: We apply weights based on the publication’s classification for both MNCS scores. Articles, Cochrane articles and
reviews are given a weight of 1 in the analysis, whereas letters, comments and editorials are given a weight of 0.25.
When comparing the citations received by the 357 publications to the average article published
in the field of clinical medicine, publications from ACE receive 2.02 times more citations than
the average publication in the field of clinical medicine (MNCS Clinical Medicine range is 1.76
to 2.57, for individual years). In other words, they receive more than twice as many citations as
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an average publication in the field. A similar state of affairs is seen, when ACE publications are
compared to an average publication in all of the WoS fields, which shows that the ACE
publications receive 1.95 times more citations than the average article in all WoS fields (MNCS
All fields range 1.72 to 2.40, for individual years; Table 7.4).
7.4
The Panel’s overall reflections on Cochrane Review Groups
(CRGs)
As can be seen from the tables above, there are differences between CRGs in the number of
reviews published over the period. Several factors need to be considered when assessing
productivity. The breadth of the research question usually impacts on the number of studies to
be included in the review, meaning that the effort and resource required to produce reviews is
not evenly distributed. The complexity of the review question is also a factor: some reviews are
methodologically challenging to conduct and require advanced statistical and reviewing skills,
which are not always immediately available within the team. Another factor is the importance
and relevance of the review question to stakeholders. Reviews will only be used if they address
meaningful questions, and therefore priority setting is an important aspect of review production.
Quality is a key factor, and Cochrane has documented the inconsistent quality of its reviews,
and its new strategy focuses on ‘fewer, better reviews’.
8
The Panel notes that the CRGs appear to work independently of each other and of the NCC.
There appears to be enthusiasm for re-introducing regular meetings and for working together
more closely. In light of the increasing complexity of Cochrane methods, the need to adhere to
methodological standards and to ensure stakeholder involvement in priority setting, the Panel
strongly supports the need for closer working and shared learning between all Cochrane
entities in Denmark. This aligns with the new arrangements and governance structures that
Cochrane has recently implemented.
9
As part of these new arrangements, all CRGs sign a
Collaboration Agreement with Cochrane, which outlines expectations, requirements and
responsibilities. Each CRG needs to be re-accredited every five years to ensure that core
functions, including review production, editorial activities organisational and collaboration are
carried out.
8
9
Further
details
are
available:
‘The
structure
and
function
of
Cochrane
Review
Groups’.
https://community.cochrane.org/sites/default/files/uploads/inline-
files/The%20Structure%20and%20Function%20of%20Cochrane%20Review%20Groups_16Aug17_2.pdf
Further details are available: https://community.cochrane.org/organizational-info/resources/resources-groups/crg-networks-
portal/crg-network-resource
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Bilag 4
Evaluation Report Copenhagen Trial Unit
Dette bilag indeholder den evalueringsrapport, som det internationale evalueringspanel har
udarbejdet for Copenhagen Trial Unit (CTU).
Ud over evalueringspanelets evaluering af Copenhagen Trial Unit indeholder evalueringsrap-
porten også panelets evalueringsperspektiver på den danske Cochrane Review-gruppe, som
er tættest
knyttet
til Copenhagen Trial Unit:
The Cochrane Hepato-Biliary Group (CHBG).
65
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Evaluation of the Copenhagen Trial Unit
Final Report
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Amanda Sowden (Chair)
Professor and Deputy Director and leader of University of York’s Centre for Review and Dissemination’s
research programme in public health, United Kingdom
Terje P. Hagen (Co-chair)
Professor and Head at Institute of Health and Society, University of Oslo, Norway
Diederick Grobbee
Professor of Clinical Epidemiology, Founder of the Julius Center, University Medical Center Utrecht, The
Netherlands
Eva Swahn
Professor, Department of Medical and Health Sciences, Division of Cardiology, Linköping University &
Department of Cardiology, University Hospital, Linköping, Sweden.
Merete Osler
Clinical Professor at Department of Public Health, UC and consultant, Center for Clinical Research and
Prevention, Bispebjerg and Frederiksberg Hospital, Denmark
Mickael Bech
Professor in healthcare leadership at Crown Prince Frederik Center for Public Leadership, Aarhus University,
Denmark
September 2019
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Table of contents
Executive summary ............................................................................................ 1
Background of the evaluation ................................................................................. 1
Conclusions of the Evaluation Panel ...................................................................... 1
1
Introduction ............................................................................................... 3
1.1
1.2
1.3
1.4
1.5
Background ................................................................................................... 3
The evaluation .............................................................................................. 3
The evaluation panel .................................................................................... 4
Evaluation protocol ....................................................................................... 5
The evaluation process and methods ........................................................... 6
2
The Copenhagen Trial Unit – management and organisation ................... 7
2.1
2.2
2.3
2.4
Background, organizational placement and funding..................................... 7
Purpose and strategy .................................................................................... 8
Organisation and management .................................................................... 9
The Panel’s assessment of the overall management and organisation ....... 9
3
Research production and quality ............................................................. 11
3.1
3.2
3.3
3.4
Research production and impact – the CTU .............................................. 11
Research production and impact – CHBG ................................................. 12
PhD candidates and the CTU’s involvement in PhD programmes ............. 13
The Panel’s overall assessment of research productivity and quality ........ 14
4
Impact and relevance .............................................................................. 15
4.1
4.2
4.3
Target groups and examples of trials with significant relevance ................ 15
Interventions in the public debate ............................................................... 16
The Panel’s assessment of the impact of the centre on clinical practice and
clinical guidelines ........................................................................................ 17
5
Evaluation of collaborations and partnerships ......................................... 18
5.1
5.2
Overview of collaborations and partnerships .............................................. 18
Assessment of collaboration and partnerships ........................................... 18
6
Options for organising the activities of the CTU and the CHBG............... 20
6.1
6.2
6.3
Summary of the assessment ...................................................................... 20
Options for the CTU .................................................................................... 20
Options for the CHBG ................................................................................. 21
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Executive summary
Background of the evaluation
The Nordic Cochrane Centre (NCC) and the Copenhagen Trial Unit (CTU) receive funding from
the Ministry of Health via the National Finance Act. This funding has been in place since 1993
and, until now, no formal evaluation of the work of the Centres has taken place. Such an
evaluation was requested by the Ministry of Health and was organised and overseen by VIVE,
the Danish Centre for Social Science Research. The intent of the evaluation was to assess
whether the purpose of the two centres as stated in the National Finance Act grant has been
fulfilled. The Finance Act states:
“The activities in the Cochrane area include preparation of systematic reviews of
health care interventions, prevention of diseases, diagnostics, treatment and care.
CTU supports and performs scientifically relevant clinical trials, i.a. as part of the
Cochrane Collaboration.”
(the National Finance Act 2018, translation by VIVE).
An international Panel of six people carried out the evaluation. The evaluation focused on i)
management and organisation of the centres; ii) research production and quality; iii) impact
and relevance of the centres’ activities and iv) collaborations and partnerships.
The results of the evaluation are presented in separate reports for each of the two centres. This
report presents the results of the evaluation of the CTU. The report also includes perspectives
on The Cochrane Hepato-Biliary Group (CHBG), which is also funded under the Finance Act.
Conclusions of the Evaluation Panel
In the Panel’s view the CTU has achieved its main goals: support, coordinate and conduct
randomized clinical trials; participate in the development of methods for randomised clinical
trials and meta-analyses; educate students and researchers in evidence-based medicine,
randomised clinical trials, meta-analyses and trial sequential analysis; and support, coordinate,
and conduct systematic reviews of the literature.
Furthermore, the CTU has published its research in a range of high impact medical journals.
The impact has been substantial as CTU-studies have influenced clinical practice and
stimulated public debate and discussion.
Despite the CTU’s considerable achievements, the Panel questions the sustainability of the
current operating model, given its small size, dependency on Ministry funding, positioning in
Rigshospitalet and complex governance structures. The Panel concludes that there is an
urgent need to consider the options for a revised governance structure. The Panel has
discussed several alternatives, including reorganising the CTU as a regional trials unit,
incorporating the CTU into a university environment and creating a broader Center for
Biostatistics and Epidemiology.
In light of the increasing complexity of Cochrane methods, the need to adhere to
methodological standards and to ensure stakeholder involvement in priority setting, the Panel
suggest a closer collaboration and shared learning between all Cochrane entities in Denmark.
1
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This aligns with the new arrangements and governance structures that Cochrane has recently
implemented.
2
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1
1.1
Introduction
Background
The Ministry of Health has asked VIVE, The Danish Center for Social Science Research, to
evaluate the Nordic Cochrane Centre (NCC) and the Copenhagen Trial Unit (CTU).
The NCC and CTU receive a grant each year through the National Finance Act. In the National
Finance Act for 2018, it is stated:
”In 2018, DKK 17.8 million were allocated for financing of the Cochrane and
Copenhagen Trial Unit (CTU). The activities in the Cochrane area include
preparation of systematic reviews of health care interventions, prevention of
diseases, diagnostics, treatment and care. CTU supports and performs scientifically
relevant clinical trials, i.a. as part of the Cochrane Collaboration. The allocated funds
from 2009 onwards include DKK 0.5 million for the financing of free access for all to
the Cochrane Library”
(the National Finance Act 2018, translation by VIVE).
According to information from the centres, the 17.8 million DKK in 2018 were distributed as
follows:
The Nordic Cochrane Centre: 7,335,000 DKK
Copenhagen Trial Unit, including the Cochrane Hepato-Biliary Group: 7,735,000
The Cochrane Review Groups: 2,730,000 DKK
o
Herlev Hospital: 1,316,000 DKK (The Cochrane Anaesthesia and Cochrane
Emergency and Critical Care Groups)
o
Bispebjerg Hospital: 1,413,000 DKK (The Cochrane Colorectal Group).
1.2
The evaluation
The results of the evaluation are presented in separate reports for each of the two centres. This
report presents the results of the evaluation of the Copenhagen Trial Unit (CTU). In addition to
the CTU, the report also includes perspectives on the Cochrane Hepato-Biliary Group.
The main aim of the evaluation is to assess whether the purpose of the National Finance Act
grant has been fulfilled, by evaluating the scale of research production and its quality as well
as the societal impact of the centres and their external collaborations and partnerships.
Accordingly, the evaluation includes both formative elements focusing on broadening the
understanding of the institute's characteristics for the purpose of continuous improvement and
summative elements focusing on accountability to the entity that funds the running of the
centre.
Specifically, the evaluation addresses the following four topics:
Management and organisation of the centres
Research production and quality
Impact and relevance of the centres’ activities
Collaborations and partnerships.
3
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These topics are presented in further details below.
1.3
The evaluation panel
An international evaluation panel has carried out the evaluation and is responsible for writing
this report. The appointment of the chair of the evaluation panel was done by The Independent
Research Fund Denmark [Danish name: Danmarks Frie Forskningsfond, DFF] based on a
nomination by VIVE. VIVE appointed the additional members of the evaluation panel based on
nominations by DFF. VIVE requested DFF to nominate three internationally well-acknowledged
researchers from the medical sciences council under DFF and two researchers from the social
science council under DFF. The candidates from the medical sciences council were to have
insight into the processes and methods of randomised studies, systematic reviews and
experience with assessing the quality and impact of health care research. The candidates from
the social sciences council under DFF were to have insight into the Danish health care system
and management and organization of health research. In order to ensure the impartiality of the
evaluation, a basic criterion in the nomination of candidates, in addition to the professional
skills, was that they must not have had collaborations or other close relations with the NCC,
CTU or their international counterparts in the last five years. DFF, in accordance with the
Danish Gender Equality Act, nominates at least one male and one female candidate for each
seat in the panel. After a process of nomination and invitation of nominees by DFF, VIVE
received a list from DFF of five researchers from the medical sciences council and two
researchers from the social sciences council, all of whom accepted the invitation. The
appointment of the additional members was done by VIVE, after consulting the chair of the
evaluation panel. Based on an overall assessment of the individual and complementary
qualifications, VIVE appointed three of the five researchers who accepted the invitation from
the medical sciences council and the two researchers that accepted the invitation from the
social sciences council. All panel members were appointed in their own personal capacity. The
composition of panel members has been subject to a hearing by the NCC and the CTU.
The panel consists of six members with complementary competencies in reviews in public
health, clinical research, trials and management, and organisation of health research:
Amanda Sowden (Chair). Professor and Deputy Director and leader of the University
of York’s Centre for Reviews and Dissemination’s research programme in public
health, United Kingdom
Terje P. Hagen (Co-chair). Professor and Head at the Institute of Health and Society,
University of Oslo, Norway
Diederick Grobbee. Professor of Clinical Epidemiology and founder of the Julius
Center, University Medical Center Utrecht, The Netherlands
Eva Swahn. Professor at the Department of Medical and Health Sciences, Division of
Cardiology, Linköping University & the Department of Cardiology, University Hospital,
Linköping, Sweden
Merete Osler. Clinical Professor at the Department of Public Health, University of
Copenhagen & consultant at the Center for Clinical Research and Prevention,
Bispebjerg and Frederiksberg Hospital, Denmark
Mickael Bech. Professor in healthcare leadership at Crown Prince Frederik Center for
Public Leadership, Aarhus University, Denmark.
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1.4
Evaluation protocol
The evaluation protocol elaborated by VIVE and the chair of the panel covers four topics:
Management and organisation
Research production and quality
Impact and relevance
Collaborations and partnerships.
The protocol contains the questions guiding the evaluation panel’s assessment and is
presented in further detail below.
Management and organisation
The evaluation panel was asked to give a general description and assessment of the
governance structure and the management and organizational structure of each of the two
centres. The description and assessment were to address the following:
An overall description and assessment of the governance structure of the centre,
including reflections on the governance structure’s ability to hold the management of
the centre accountable
A reflection on the strategy of the centre in relation to the purpose and mission of the
centre
A description and assessment of the management and organizational structure of the
centre, including reflections on the organizational and management structures’
adequacy for accomplishing the centre´s purpose and strategy, and the expediency of
the decision-making structure and the division of labour between the different sections
of the centre
An assessment of the organizational support for researchers
An assessment of the centre’s ability to attract external resources from research
councils, research funds, EU etc.
A reflection on the expediency of governance structure, the management and
organizational structure compared to similar types of institutions.
Research production and quality
The panel was asked to give an assessment of the quantity and quality of research from each
of the two centres. The assessment was to include the following elements:
A count of publications over the past five years divided into main types of publications
The average number of annual publications per researcher for the centre at large
An assessment of the quality of research based on bibliometric indicators
Reflections on the level and quality of output compared to economic resources
An assessment of the centres’ production of PhD candidates, including reflections on
the centres’ involvement in PhD programmes
An overall assessment of the productivity of the centre and the importance and quality
of the research.
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Impact and relevance
The evaluation panel was asked to give its assessment of the impact and relevance of each of
the two centres’ activities for the Danish society. The assessment was to include the following
elements:
An assessment of the impact of the centre on clinical practice and clinical guidelines.
Reflections on how the centres’ research and other activities create value in various
parts of the Danish society
Reflections on the centres’ impact on the public debate in Denmark
Collaborations and partnerships
The evaluation panel was asked to give its assessment of each of the two centre’s national
and international collaborations and partnerships. The assessment was to include the following
elements:
An assessment of the level of national and international collaboration of the centre,
including reflections on the level of national vs. international collaborations, and the
role of the centre in the collaborations
An assessment of the output of the collaborations
Reflections on importance of the collaboration for accomplishing the centre´s purpose
and strategy.
1.5
The evaluation process and methods
The evaluation of the two centres was carried out in parallel and is based on both quantitative
and qualitative data. The data include:
Self-evaluation reports by the NCC and CTU
Site-visit by the evaluation panel in Copenhagen 20
th
to 22
nd
May 2019
Documentation and additional data collected by VIVE
Both the self-evaluation reports, and the documentation and additional data collected by VIVE,
provide information on each of the four topics of the evaluation. The site-visit included meetings
with management, employees and a selected number of stakeholders of each centre as well
as a meeting with the management of the hosting organisation, The Danish National Hospital
– ‘Rigshospitalet’ and a teleconference with the Chief Executive Officer of Cochrane.
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2
The Copenhagen Trial Unit – management
and organisation
This section provides a short overview of the historical background of the Copenhagen Trial
Unit (CTU) and its affiliated Cochrane review group: the Cochrane Hepato-Biliary Group
(CHBG). The CHBG focuses on interventions for patients with liver and biliary diseases. This
section also provides a description and assessment of the current organizational arrangements
and the governance structure of the CTU.
2.1
Background, organizational placement and funding
The CTU was established following a decision by the Copenhagen City Council in October
1994. The decision marked the end of a long process in which several alternatives for
increasing the quality of the clinical research in Denmark were considered. At the same time,
the Copenhagen Health Services were transformed into The Hospital Association of the Capital
(Hovedstadens Sygehusfællesskab) with the aim of running health care services targeting the
population in the City of Copenhagen and the City of Frederiksberg. On June 1, 1995, Christian
Gluud, was appointed Head of the CTU. On January 1, 1996, after a phase of planning and
preparation, the CTU was up and running. After four years at The Municipal Hospital
(Kommunehospitalet), the CTU moved to The National Hospital (Rigshospitalet) in 2000.
During 1995 to 2006, the CTU received funding from Hovedstadens Sygehusfællesskab. In
1996, the first year of full activity, the funding was about DKK 2.5 million (approximately DKK
6.85 million in currently). Following the structural reorganisation of Danish municipalities and
regions in 2007, the governance of the CTU was transferred to the Capital Region of Denmark.
At the same time, the Danish state initiated an earmarked grant to the Capital Region for the
CTU’s running costs. During 2018, funding from the Danish State amounted to DKK 7.735
million. Additional to state funding, the CTU received limited funding from user fees.
The CTU is collaborating with Cochrane in preparing, maintaining and disseminating
systematic reviews of the effects of health care interventions. The Editorial Team of the CHBG
is hosted by the CTU. The CHBG grew in parallel with the CTU and has functioned as an
integrated part of the CTU, providing expertise in systematic reviewing and literature
searching.
1
The CTU and the Nordic Cochrane Centre (NCC) are connected through their
collective government funding and are situated next door to each other at Rigshospitalet. Their
activities are completely independent of each other, however. For further information, see the
accompanying NCC Evaluation Report.
The CTU operates as a department within Rigshospitalet. The economic relationship with
Rigshospitalet is headed by the Chief Financial Department at the Capital Region of Denmark
and according to the rules and regulations of this department. The Capital Region has strict
and specific procedures for the use of grants of the Capital Region of Denmark, who control
the Danish state grant to the CTU and the CHBG, and other revenue based research grants
from both domestic and foreign investigators, including EU grants. Although the CTU is
organised as a department under Rigshospitalet, and refers to the vice-president of
Rigshospitalet in administrative and financial matters, there is no regular meeting structure or
1
Further details of CTU’s and CHBG’s history can be found on the organisations’ websites: http://www.ctu.dk/ and
https://hbg.cochrane.org/
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explicitly defined governance requirements for the CTU. According to both the CTU and
Rigshospitalet, the interaction is ad hoc, and the CTU does not have regular meetings with
Cochrane. However, the CHBG signed a five-year collaboration agreement with Cochrane in
June 2018, which defines the goals, including the responsibilities (commitment to produce
evidence), requirements to adhere to Cochrane policies and standards for reviews, ensuring
that the products are accessible and that the group is sustainable. In 2021, the CHBG’s work
will be assessed in detail based on this agreement.
The CTU does not have a regular board as such but had an advisory board in the period 1996
to 2006. According to the CTU’s self-evaluation, the members of the advisory board provided
good advice and recommendations, especially regarding strategic and tactical matters. Over
time, the vision, mission and strategy of the CTU became clearer and the experience of the
team more extensive, and the advice offered by the advisory board was not necessarily timely.
Therefore, the CTU chose to approach the members of the advisory board on an ad hoc basis.
Gradually, this approach made the annual meetings less necessary. The members of the
advisory board were elected by the CTU among the researchers of Hovedstadens
Sygehusfællesskab (H:S) with the greatest experience in conducting randomised clinical trials.
2.2
Purpose and strategy
The CTU presents itself as a non-specialty-oriented clinical intervention research unit. The
centre offers collaboration at all stages of clinical research as well as education in organising
clinical trials. The CTU’s overall mission is to strengthen Danish clinical research in order to
improve patients’ prognosis and to contribute to creating credible and reliable clinical research.
The CTU’s aims are to:
Support, coordinate and conduct randomised clinical trials in the primary and
secondary health-care sectors. The trials focus on prevention, diagnosis, therapy and
health care
Participate in the development of methods for randomised clinical trials and meta-
analysis
Educate students and researchers in evidence-based medicine, randomised clinical
trials, meta-analyses and trial sequential analysis
Support, coordinate and conduct systematic reviews of the literature using meta-
analysis, and participate in the international Cochrane Collaboration.
The Copenhagen Trial Unit’s strategy is primarily based on the following activities directed at:
reducing the risk of testing the wrong questions in randomised clinical trials by
conducting systematic reviews
reducing the risk of systematic error (bias) by conducting trials at low risks of bias;
reducing the risk of random error (play of chance) by conducting trials sufficiently large
to answer the questions posed
reducing the risks of other design errors or other errors in research by employing
proper PICOT (participants; intervention; control; outcomes; time points); IT
infrastructure; SOPs for clinical trials and systematic reviews; detailed statistical
analysis plans; data management plans; and transparency regarding plans and data
increasing the knowledge and understanding of systematic reviews and randomised
clinical trials.
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2.3
Organisation and management
The CTU employs approximately 20 people, including student assistants on a part-time basis.
Twelve to fourteen people constitute the core staff. They work as trialists, epidemiologists,
statisticians and information-technology specialists.
The CTU’s main activities are anchored in the individual steering committees for the
randomised clinical trials or the author teams for the individual systematic reviews. These core
products undergo continuous and systematic quality improvement according to the pertinent
SOPs and relevant strategies. Projects as well as other work issues are discussed at the once-
a-week staff meetings of the CTU and the CHBG. The usual topics for discussion include:
randomised clinical trials, systematic reviews and IT.
When initiating a new collaboration with researchers, the CTU arranges a series of meetings
and outlines a contract stating the responsibilities of each of the collaboration partners. This
includes randomisation, data management etc. The CTU prefers to participate as a research
partner and have a seat in the research project’s steering committee.
Ten years ago, the CTU received funding to carry out network activities. For example, the
centre is a member of the Nordic Trial Alliance and ECRIN. The CTU is still involved in these
activities (for example as scientific board members), but on an un-funded basis.
2.4
The Panel’s assessment of the overall management and
organisation
The CTU was established to strengthen the quality of Danish clinical research. As will be
emphasised later in this report, this has been achieved. The CTU has played an important role
in Danish clinical research by developing and implementing standards for clinical trials and by
offering relevant educational courses.
The organisation of the CTU was changed following the structural reform of Danish
municipalities and regions in 2007. As a consequence of the reform, the responsibility for the
CTU was transferred from Hovedstadens Sygehusfællesskab to The Capital Region. However,
at the same time the central state initiated an earmarked grant to the CTU. Though not unusual,
earmarked grants, in the view of the Panel, break with the fundamental principle of the Danish
municipal and regional block grant funding system. The earmarked grant has provided stability
in funding over time, but it may also have reduced the integration of the CTU into a broader
regional context. The Panel noted that the CTU is heavily dependent upon the earmarked grant
from the central state and that this may threaten long-term sustainability if the grant is reduced
or removed. The CTU has managed received additional funding but few major grants from
other funders.
That CTU no longer has a working advisory board, and there is no regular meeting structure
between Rigshospitalet, which is the CTU’s governing administrative body. This further
strengthens the Panel’s impression of a loosely coupled organizational system. Loosely
coupled organisations may strengthen local autonomy but may also reduce the organisations’
ability to reach overarching goals and to cooperate with other relevant parts of the wider
hospital or regional organisation.
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The Panel notes that the CTU is quite small and accentuates that the organisation is different
from the organisation of similar units in Denmark as well as in others countries. The trend in
other Danish regions, and also in the other Scandinavian countries, has been to build
methodological support units for clinical research that offer a broad set of methodological
approaches. Such units are often bigger than the CTU, may be organised in cooperation with
universities and hospitals and, as a reflection of these features, may have greater capacity than
the CTU to engage in applications for larger grants and projects, for example at the EU-level.
The CTU’s current host, Rigshospitalet, in meetings with the Panel also emphasised the need
for an alternative governance structure, preferably outside the hospital’s organisation.
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3
Research production and quality
The following subsections provide an assessment of the research production and impact of the
CTU and its affiliated Cochrane review group – CHBG.
We base the assessment on various bibliometric indicators used to assess research production
and the quality of research centres. The five indicators capture the involvement and productivity
of the centre in any of the peer-reviewed publications, as well as the performance of the
publications. The analyses are restricted to publications from 2012/2014 to 2018 and include
only publications indexed in the Web of Science (WoS) database.
2
3.1
Research production and impact – the CTU
From 2014 to 2018, the CTU registered 365 publications, of which 199 (55% of total
publications) are journal articles and 78 (21% of total publications) are Cochrane articles (Table
3.1). The numbers of articles peaked in 2015 followed by a slight decline. The decline in
publications coincided with an increase in the Cochrane articles.
Table 3.1 Number and publication classification of the publications from the
Copenhagen Trial Unit
WoS Classification
2012
No.
Article
Cochrane
Editorial
Letter
Review
Total
27
11
0
5
4
47
2013
No.
37
11
4
6
2
60
2014
No.
40
14
0
8
7
69
2015
No.
48
16
0
4
5
73
2016
No.
44
15
2
7
8
76
2017
No.
39
15
2
3
20
79
2018
No.
28
18
4
7
11
68
2014-2018
Total
No.
199
78
8
29
51
365
2012-2018
Total
No.
263
100
12
40
57
472
Abbreviations: WoS: Web of Science, No.: Number of observations.
Des:
The table shows CTU’s publications from 2012 to 2018, divided into the five publication categories used in the
analyss.
When assessing the author order, the CTU had 41 (11.3% of total publications) first
authorships, 132 (36.2% of total publications) last authorships, and 284 co-authorships (data
not shown in tables).
Comparing the citations received by the publications to those of the average article published
in the field of clinical medicine in general, publications from the CTU receive 2.25 times more
citations than articles in general. A similar result is obtained when comparing the CTU
publications to an average publication in all of the WoS fields. CTU’s publications receive 2.19
times more citations than the average article in all WoS fields (Table 3.2).
2
For further description of the methods, see the VIVE working paper «The research production and quality of Copenhagen
Trial Unit and its affiliated Cochrane review group”.
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Table 3.2 Number of citations and normalised citation score for publications from
CTU
Number
TC
Mean TC
Median
TC
11.00
14.00
5.50
4.00
0.00
5.00
Max TC
MNCS
Clinical
Medicine
2.68
2.53
1.94
2.55
1.46
2.25
MNCS All
fields
2.69
2.55
1.90
2.38
1.35
2.19
Missing
Publica-
tions
4
14
8
10
12
48
2014
2015
2016
2017
2018
All years
65
59
68
69
56
317
2,039
1,305
736
453
46
4,579
31.37
22.12
10.82
6.57
0.82
14.44
335
179
69
64
6
335
Abbreviations: No.: Number of observations, TC: Total number of citations for the period, MNCS: Mean Normalised Citations
Score of the publications of a unit.
Des:
The table shows the number of publications included in the analysis. For each publication year, the total, mean,
median and maximum number of citations in the publications in that year are shown. The table further shows the
mean MNCS Clinical medicine and MNCS All fields score, which indicates whether the publications received more
(score above 1) or fewer (score less than 1) citations than the average publication in the relevant field in the given
publication year. It was not possible to obtain citation data for all the CTU publications. The most frequent missing
publication type is Cochrane protocols.
Note: We apply weights based on the publications’ classification for both MNCS scores. Articles, Cochrane articles and
reviews are given a weight of 1 in the analysis, whereas letters, comments and editorials are given a weight of 0.25.
When focusing on articles from the two publication categories ‘articles’ and ‘Cochrane articles’
(excluding reviews, letters and editorials), there are 232 publications, which have an average
MSCN Clinical Medicine score of 2.34 and a MNCS All fields score of 2.29. Both results imply
that the publications from the CTU receive more than twice as many citations as an average
publication in the two fields of WoS.
3.2
Research production and impact – CHBG
From 2014 to 2018, CHBG registered 197 publications, of which 180 (91% of total publications)
are Cochrane articles and 3 (0.2% of total publications) are journal articles (Table 3.3).
Table 3.3 Number and publication classification of the publications from CHBG
WoS Classification
2012
No.
Article
Cochrane
Editorial
Letter
Review
Total
0
36
0
0
2
38
2013
No.
2
44
2
0
3
51
2014
No.
2
33
0
1
3
39
2015
No.
1
45
0
1
2
49
2016
No.
0
26
1
0
3
30
2017
No.
0
39
0
0
0
39
2018
No.
0
37
0
1
2
40
2014-2018
Total
No.
3
180
1
3
10
197
2012-2018
Total
No.
5
260
3
3
15
286
Abbreviations: WoS: Web of Science, No.: Number of observations.
Des:
The table shows CHBG’s publications from 2012 t0 2018, divided into the five publication categories used in the
analysis.
The 97 publications by the CHBG gained 784 citations from 2014 to 2018 (Table 3.4). Most
citations are for articles published in 2014 and 2015, which is expected as articles from those
years have had longer exposure time than articles published in 2017 or 2018. The average
article receives eight citations for all years (Mean TC range 1-15 for individual years).
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Table 3.4 Number of citations and normalised citation score for publications from
CHBG
Number
TC
Mean TC
Median
TC
9
7
6
3
0
4
Max TC
MNCS
Clinical
Medicine
91
26
26
18
8
91
1.29
0.97
1.47
1.83
2.17
1.54
MNCS All
fields
1.29
0.97
1.44
1.71
2.00
1.48
Missing
Publica-
tions
12
32
17
15
24
100
2014
2015
2016
2017
2018
All years
27
17
13
24
16
97
403
151
104
108
17
783
15
9
8
5
1
8
Abbreviations: No.: Number of observations, TC: Total number of citations for the period, MNCS: Mean Normalised Citations
Score of the publications of a unit.
Des:
The table shows the number of publications included in the analysis. For each publication year, the total, mean,
median and maximum number of citations of the publications in that year are shown. The table further shows the
mean MNCS Clinical medicine and MNCS All fields score, which indicates whether the publications received more
(score above 1) or fewer (score less than 1) citations than the average publications in the relevant field in the given
publication year. It was not possible to obtain citation data for all the NCC publications. The most frequent missing
publication type is Cochrane protocols.
Note: We apply weights based on the publications’ classification for both MNCS scores. Articles, Cochrane articles and
reviews are given a weight of 1 in the analysis, whereas letters, comments and editorials are given a weight of 0.25.
When comparing the citations received by the 97 publications to those of the average article
published in the field of clinical medicine, publications from CHBG receive 1.54 times more
citations than the average publication in the field of clinical medicine (MNCS Clinical Medicine
range 0.97-2.17 for individual years). In other words, they receive more citations than an
average publication in the field. A similar state of affairs is seen when CHGB publications are
compared to an average publication in all of the WoS fields, which shows that the CHGB
publications receive 1.48 times more citations than the average article in all WoS fields (MNCS
All fields range 0.97-2.00 for individual years). According to the CTU’s self-evaluation, works
by the CHBG have been cited over 100 times in more than 30 international guidelines.
3.3
PhD candidates and the CTU’s involvement in PhD programmes
One of the CTU’s main goals is to educate students, candidates and researchers in evidence-
based medicine, randomised clinical trials, meta-analyses and trial sequential analysis.
Supervising PhD students is viewed as a way to achieve this goal. Table 3.5 shows the number
of PhD students.
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Table 3.5 Official supervision by members of Copenhagen Trial Unit staff of PhD
projects (excluding personnel by the CHBG)
Category per year
PhDs – initiated
4
PhDs – ongoing
4
Defended PhD dissertations
4
5
3
7
1
3
4
3
1
22
10
3
0
1
1
9
2014
2015
2016
2017
2018
Total
From 2014 to 2018, no PhD fellows were employed at the CTU after their defence. However,
the CTU has maintained collaboration with a large number of the PhDs, carrying out joint
research and publishing in a broad range of topics, sometimes outside the topic of the PhD
thesis.
3.4
The Panel’s overall assessment of research productivity and
quality
In the Panel’s view, the CTU is characterised by high productivity of original research and
review publications. Thus, each year (2014-2018) the CTU has published 10-14 publications
per employee, or per 1 million of the government grant. Around 30% of the publications include
CTU employees as the first or senior author. The CHBG has mainly published systematic
reviews but also with a high productivity of above 20 publication per year per employee.
The original papers have been published in a range of medical journals, several in high impact
journals. CTU staff have been actively involved in PhD supervision, both as main and co-
supervisors, and have lectured on PhD courses at the University of Copenhagen. The CTU
has been involved in a large number of courses and symposia. Most of these have been abroad
and targeted at international audiences.
Additionally, the CTU has participated in several important research projects that have
influenced treatment of patients worldwide, for example in coronary heart disease and sepsis
treatment.
Although research quality and method development within clinical research are part of the
mission of the CTU, the centre has relatively few publications on theory or methodology. Many
of the teaching activities have been conducted abroad, and the CTU has not been responsible
for PhD courses in, for instance, RCTs, clinical epidemiology or GCP in Denmark.
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4
Impact and relevance
This section describes and analyses the CTU’s and CHBG’s impact and relevance. The
description is based on a broad range of sources, including the CTU’s self-evaluation and the
Panel’s impressions from the site visits.
The impact of the CTU and CHBG can be measured along several dimensions. The Panel has
concentrated on trials and interventions with significant relevance in the public debate.
4.1
Target groups and examples of trials with significant relevance
As a reflection of the CTU’s aims, it has had a broad audience and range of target groups since
1995. In relation to conducting randomised clinical trials and systematic reviews, the audience
and target groups are health researchers from academia and industry. Moreover, they are from
different educational backgrounds and specialities, such as physicians, nurses,
physiotherapists and engineers. The trials have covered various diseases, from foot warts to
schizophrenia. Supported researchers are primarily from the capital region (75%), with some
collaborations with researchers from the other regions (12%) in Denmark and internationally
(21%). The regional distribution of collaborators may at least partly be representative for the
regional distributions of trials.
According to the self-evaluation report, the CTU prefers to do clinical research with the joint
efforts of academic researchers at Danish universities and university hospitals, as well as small
private start-ups. According to statements from the CTU members during the site visits, the
experience with development plans involving pharmaceutical or medical device industries, or
where these industries were involved as sponsors have not always been positive because of
their unwillingness to choose the most valid methods for the systematic reviews and lack of
transparency of data.
Examples of methodological developments with CTU participation:
-
-
-
-
Development of thresholds for statistical and clinical significance in randomised trials and
systematic reviews
Trial Sequential Analysis as a tool for handling imprecision and risk of random errors in
randomised trials and systematic reviews
Risk of bias and systematic review methodology
Development of OpenClinica software for trials: this includes improving system stability
and speed, and adding functionality for randomisation, monitoring and various self-service
capabilities.
Examples of potential impact on clinical practices and clinical guidelines in the past five years
include (listed from the CTU’s self-evaluation):
-
The CLARICOR trial published in the BMJ (clarithromycin versus placebo for patients with
stable coronary artery disease) showed, surprisingly, that clarithromycin increased
mortality even at the 10-year follow-up. Since the first published results in 2005, the CTU
has repeatedly informed the authorities of the possible adverse reactions of clarithromycin
(meetings at European Medicines Agency (EMA), London and Danish Medicines Agency;
Copenhagen). At the time of the first publication of the results, the United States Food and
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-
-
-
Drug Administration (FDA) issued a safety alert. In 2018, the FDA added a new warning to
clarithromycin's label, advising prescribers to choose other antibiotics in patients with
coronary artery disease. This happened after FDA had conducted a large observational
study confirming CLARICOR’s results. In the same period, the Danish and European
medicines agencies have changed nothing in their recommendations for the use of
clarithromycin.
The 6S trial (hydroxyethyl-starch versus placebo infusion to septic patients) published in
NEJM (49) and the subsequent systematic review in BMJ has contributed to EMA and the
‘Surviving Sepsis Campaign’ recommending not using hydroxyethyl-starch to septic,
burned and critically ill patients. Also, the EMA recommends monitoring perioperative
patients receiving hydroxyethyl-starch products for kidney problems for at least 3 months
after infusion of starch. Twice, the EMA Pharmacovigilance Risk Assessment Committee
(PRAC) and the Coordination Group for Mutual Recognition and Decentralised Procedures
– Human (CMDh) (http://www.hma.eu/352.html) have endorsed the recommendation to
suspend the marketing authorisations of hydroxyethyl-starch solutions for infusion across
the European Union, but twice the European Union has opposed such a definite
withdrawal.
The TTM-1 trial (cooling to 33 to 34 degrees Celsius versus 36 degrees Celsius to patients
with out-of-hospital cardiac arrest) published in NEJM has led the ICU department at
Rigshospitalet to cool unconscious patients to 36 degrees Celsius rather than the
previously recommended 33-34 degree Celsius. Several other ICUs in Europe and
Australia have also adopted this strategy. The TTM-2 trial, presently randomising patients,
aims to determine whether unconscious patients with out of hospital cardiac arrest should
be cooled at all if the temperature is lower than 37.8 degrees.
The TRISS trial (patients in the intensive care unit (ICU) who had septic shock and a
haemoglobin concentration of 9 g per decilitre or less to receive 1 unit of leukoreduced red
cells when the haemoglobin level was 7 g per decilitre or less (lower threshold) or when
the level was 9 g per decilitre or less (higher threshold) during the ICU stay), published in
NEJM and the subsequent systematic review published in BMJ, has contributed to the
‘Surviving Sepsis Campaign’ guidelines (51) recommending not to transfuse septic patients
before the haemoglobin was 7.0 g/dl or less.
The SUP-ICU trial (patients admitted to the ICU for an acute condition (i.e. an unplanned
admission) who were at risk of gastrointestinal bleeding received 40 mg of intravenous
pantoprazole (a proton-pump inhibitor) versus placebo daily during the ICU stay) published
in NEJM and the subsequent systematic review in Intensive Care Medicine has led the ICU
department at Rigshospitalet not to use proton pump inhibitors prophylactic for all patients
at risk of gastrointestinal bleeding, but to reserve this intervention for patients exhibiting
signs of gastrointestinal bleeding.
4.2
Interventions in the public debate
According to the self-evaluation, the CTU strives to base its research on a ‘results-driven’
approach rather than a ‘hypothesis-driven’ approach. This chosen approach rules out the
intention to deliberately impose or dictate pre-specified opinions, and in many cases the
conclusion from the research is that there is not enough evidence to either support or refute a
given intervention. Such findings are important to the scientific eye but seldom create public
debate. In some cases, high quality evidence accumulates, and reliable estimates of the long-
term balance of risks and benefits of a given intervention can be reached. At times, these
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research findings have been controversial. The CTU lists several examples in its self-
evaluation report:
In February 2017, the CTU published a systematic review on selective serotonin
reuptake inhibitors (SSRIs) (62). The study concluded that SSRIs might have
statistically significant effects on depressive symptoms. However, SSRIs were also
associated with significantly higher risks of both serious and non-serious adverse
events, and the potential small beneficial effects seem to be outweighed by harmful
effects. These findings triggered a substantial public debate in several media channels.
Another example of the impact of the CTU on the public debate involves the findings
on vitamin and mineral supplements, which raises doubts about the common beliefs
that vitamin and mineral supplements are necessary for good health. Christian Gluud
participated in the BBC Horizon documentary on the matter: BBC Horizon 25.10.2018:
Trial – Vitamin Pills: Miracle or Myth?
The systematic reviews on methylphenidate for children and adolescents have been
used in another BBC documentary, called ‘The Doctor Who Gave Up Drugs’ (BBC
One) by Dr Chris van Tulleken.
In March 2017, the CTU published a systematic Cochrane review on the effects of
direct-acting antivirals (DAAs) for hepatitis C. This was the first systematic review
assessing the clinical effects of DAAs. The results from the Cochrane review and the
BMJ article discussing the review results, received tremendous attention, both in
Denmark (interview in national radio, several articles etc.) and internationally.
4.3
The Panel’s assessment of the impact of the centre on clinical
practice and clinical guidelines
The CTU’s work has comprised an important resource for many clinicians, mainly at hospitals
in the Capital Region, by providing high quality assistance in planning, conducting and
analysing clinical trials. Results from several of the CTU-studies have also influenced clinical
practice worldwide. Important examples include the CLAROCOL and 6S trials.
Some of the systematic reviews on vitamins and antidepressants have received considerable
media attention and discussion. The latter has initiated a heated debate between the CTU and
Danish psychiatrists, and the work has been turned down by the Danish Medical Agency.
Although public opinions on some of these matters have been diverse, it is plausible to believe
that the debate will help drive science forward by encouraging more researches and doctors to
investigate the relationship between the beneficial and harmful effects of interventions. The
Panel questions whether some of the debates could have been played out within the medical
society before entering the public sphere. This raises questions related to the governing
structure of the CTU, which the Panel will return to later in the report.
The CTU has contributed to the training of students and researchers in conducting RCTs and
in methodological development in general. This may have an impact on the quality of future
research.
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5
Evaluation of collaborations and partnerships
The section provides a short overview of the CTU’s and CHBG’s collaborations and
partnerships with other organisations over the past five years, as well as the Panel’s evaluation.
5.1
Overview of collaborations and partnerships
The CTU lists 70 collaborators and partnerships in the past 5 years, of which most (59%) are
national. Most of CHBG’s 23 collaborations and partnerships (70%) are international (Table
5.1).
Table 5.1 Collaborators ad partnerships by organisation, last 5 years*
Organisation
CTU
CHBG
Total
National
41
7
48
International
29
16
45
Total
70
23
93
* Summary statistics based on TBU’s and CHBG’s self-evaluation.
Important collaborators include the Centre for Research in Intensive Care (CRIC:
http://www.cric.nu/). The CTU has a 5-year contract with CRIC and the Innovation Fund
Denmark to undertake four large multicentre trials (SUP-ICU, HOT-ICU, AID-ICU and
CLASSIC-II) in intensive care. The cooperation has included the carrying out of systematic
reviews of the existing evidence, both before and after these trials were completed. This
collaboration has also included several international organisations participating in the trials and
systematic reviews.
Other important collaborations include the European Clinical Infrastructures Network (ECRIN)
and Nordic Trial Alliance (NTA), with the aim of improving and harmonising conditions for doing
multinational and multicentre clinical research in Europe and Scandinavia.
Some of the collaborations have led to long-lasting national and international collaborations to
improve and harmonise clinical research in cardiology, endocrinology, neurosurgery, intensive
care medicine, perioperative medicine, pain research, psychiatry and obstetrics.
The CHBG has extensive collaborations, mainly international, which reflects the work of
Cochrane. The CHBG Editorial Team office staff collaborate with more than 2180 people
around the world (more than 70 countries), and the role include peer reviewer, translator,
consumer, review author, statistician and editor.
5.2
Assessment of collaboration and partnerships
The Panel notes the extent of the collaborations and partnerships across Denmark and
internationally. The CTU has assisted in and initiated high quality, multicentre randomised
clinical trials in multiple medical research fields – among critically ill patients, cardiology
patients and children – and has improved the methods and infrastructure of these trials.
International cooperation is essential for reaching evidence-based recommendations on the
use of interventions in all specialties of clinical medicine, and the CTU has engaged in the
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development of such collaborations both within and outside Cochrane. International
cooperation is important because it raises the methodological quality and statistical power to
detect or reject clinically relevant intervention effects on patient centred outcomes, as well as
on all-cause mortality, serious adverse events and health-related quality of life. International
collaborations will probably become more important in future years as the effects of
interventions might diminish in size.
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6.1
Options for organising the activities of the
CTU and the CHBG
Summary of the assessment
In the Panel’s view, the CTU has reached its main goals: support, coordinate and conduct
randomised clinical trials; participate in the development of methods for randomised clinical
trials and meta-analyses; educate students and researchers in evidence-based medicine,
randomised clinical trials, meta-analyses, and trial sequential analysis; and support, coordinate
and conduct systematic reviews of the literature.
Furthermore, the CTU has been highly productive in carrying out original research and
systematic reviews and publishing original papers in high impact medical journals. The impact
has been substantial, as the CTU-studies have influenced clinical practice and stimulated
public debate and discussion.
However, the Panel questions whether the current organizational and financial model is
sustainable:
The earmarked grant under the Financial Act breaks with the fundamental principles
of municipal and regional funding. There is a discrepancy in the CTU’s funding from
the Financial Act and their primary collaboration with clinical researchers in the Capital
Region of Denmark, while other equivalent units in other parts of the country are paid
by the hosting regions and/or universities.
The governing structure of the unit is ambiguous and lacks legitimacy in, for instance,
Rigshospitalet, the CTU’s host organisation, and Rigshospitalet has indicated that CTU
should not be organised as part of the hospital.
The CTU is relatively small in size, lacks professional statistical expertise and,
compared to similar organisations in Denmark and other Scandinavian countries,
offers a narrow selection of methodological approaches. These limitations will probably
restrict the CTU’s ability to participate and succeed in future research programmes of
a certain size.
Taken together the Panel concludes that there is a need to discuss alternative arrangements
for organising the CTU and the CHBG.
6.2
Options for the CTU
Several alternatives should be discussed:
Model 1: the CTU as a regional trial unit
The easiest model to implement would be simply to move the CTU to the regional level and
allow its scope to broaden to cover all hospitals in the Capital Region. A CTU board would be
necessary for setting priorities and developing strategic plans. While the model is simple to
implement it will not solve all future challenges, including the problem related to lack of
statistical expertise and, more generally, the need to sustain an attractive academic
environment. The model can however be combined with increased collaboration with
Copenhagen University, for example by personnel in joint CTU/university positions.
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Model 2: the CTU as a university unit
Lack of statistical expertise can be handled by merging the CTU with the Section of Biostatistics
or other cognate sections under the Department of Public Health, University of Copenhagen.
The Section of Biostatistics conducts biostatistical research and development participates in
medical research and offers biostatistical advice to PhD students and staff engaged in
experimental and clinical medicine, public health and dentistry, in all disciplines under the
Faculty of Health Sciences. However, the funding for this model could be controversial, since
the capital region would need to fund university activity. This problem could be solved by letting
CTU stay on the Finance Act. The size of the university overhead will also be an issue with this
model.
Models 3: Copenhagen Center for Biostatistics and Epidemiology (CCBE)
This model would require Rigshospitalet and the University of Copenhagen to set up a joint
centre integrating the activities of the Department of Public Health, the CTU and possibly other
statistical units at Rigshospitalet. The CCBE would cover all aspects of biostatistics,
methodological research, advanced supervision and advice in all areas of medicine and health-
related research, from clinical and epidemiological research, to molecular biology and other
basic medical sciences. The Centre will develop statistical methods and their application to the
design, analysis and interpretation of biomedical, clinical and epidemiological studies and data
as well as provide statistical and epidemiological advice and training for researchers and
students of the Faculty of Health Science, Rigshospitalet and other hospitals in the capital
region. The capital region will fund the organisation together with University of Copenhagen
and Rigshospitalet.
6.3
Options for the CHBG
The Panel notes that the CHBG and other Cochrane entities in Denmark appear to work
independently of each other and of the Nordic Cochrane Centre. In light of the increasing
complexity of Cochrane methods, and the need to adhere to methodological standards and to
ensure stakeholder involvement in priority setting, the Panel strongly supports the need for
closer collaboration and shared learning among all Cochrane entities in Denmark. This aligns
with the new arrangements and governance structures that Cochrane has recently
implemented.
3
3
Further details are available at https://community.cochrane.org/organizational-info/resources/resources-groups/crg-
networks-portal/crg-network-resources
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