Definition of the Post-COVID syndrome using a symptom-based Post-COVID score in a prospective, multi-center, cross-sectoral cohort of the German National Pandemic Cohort Network (NAPKON).
Definition
Long-COVID
Multi-center prospective cohort study
Patient reported outcome measures
Post-COVID
Quality of life
Score
Journal
Infection
ISSN: 1439-0973
Titre abrégé: Infection
Pays: Germany
ID NLM: 0365307
Informations de publication
Date de publication:
08 Apr 2024
08 Apr 2024
Historique:
received:
08
12
2023
accepted:
25
02
2024
medline:
8
4
2024
pubmed:
8
4
2024
entrez:
8
4
2024
Statut:
aheadofprint
Résumé
The objective examination of the Post-COVID syndrome (PCS) remains difficult due to heterogeneous definitions and clinical phenotypes. The aim of the study was to verify the functionality and correlates of a recently developed PCS score. The PCS score was applied to the prospective, multi-center cross-sectoral cohort (in- and outpatients with SARS-CoV-2 infection) of the "National Pandemic Cohort Network (NAPKON, Germany)". Symptom assessment and patient-reported outcome measure questionnaires were analyzed at 3 and 12 months (3/12MFU) after diagnosis. Scores indicative of PCS severity were compared and correlated to demographic and clinical characteristics as well as quality of life (QoL, EQ-5D-5L). Six hundred three patients (mean 54.0 years, 60.6% male, 82.0% hospitalized) were included. Among those, 35.7% (215) had no and 64.3% (388) had mild, moderate, or severe PCS. PCS severity groups differed considering sex and pre-existing respiratory diseases. 3MFU PCS worsened with clinical severity of acute infection (p = .011), and number of comorbidities (p = .004). PCS severity was associated with poor QoL at the 3MFU and 12MFU (p < .001). The PCS score correlated with patients' QoL and demonstrated to be instructive for clinical characterization and stratification across health care settings. Further studies should critically address the high prevalence, clinical relevance, and the role of comorbidities. The cohort is registered at www. gov under NCT04768998.
Identifiants
pubmed: 38587752
doi: 10.1007/s15010-024-02226-9
pii: 10.1007/s15010-024-02226-9
doi:
Banques de données
ClinicalTrials.gov
['NCT04768998']
Types de publication
Journal Article
Langues
eng
Sous-ensembles de citation
IM
Subventions
Organisme : German Federal Ministry of Education and Research (BMBF) Network of University Medicine 2.0: "NUM 2.0"
ID : Grant No. 01KX2121
Investigateurs
K Alsaad
(K)
E Hamelmann
(E)
H Heidenreich
(H)
C Hornberg
(C)
N S A Kulamadayil-Heidenreich
(NSA)
P Maasjosthusmann
(P)
A Muna
(A)
M Ruwe
(M)
C Stellbrink
(C)
N Buechner
(N)
Y Dashti
(Y)
C Tessmer
(C)
B Laumerich
(B)
I Silberbaur
(I)
S Bader
(S)
M Engelmann
(M)
A Fuchs
(A)
A Langer
(A)
B Maerkl
(B)
H Messmann
(H)
A Muzalyova
(A)
C Roemmele
(C)
H Altmann
(H)
R Berner
(R)
S Dressen
(S)
T Koch
(T)
D Lindemann
(D)
K Seele
(K)
P Spieth
(P)
N Toepfner
(N)
S V Bonin
(SV)
T Feldt
(T)
V Keitel
(V)
A Killer
(A)
L Knopp
(L)
T Luedde
(T)
M Lutterbeck
(M)
M Paluschinski
(M)
J P V Pereira
(JPV)
J Timm
(J)
D Kraska
(D)
A E Kremer
(AE)
M Leppkes
(M)
J Mang
(J)
M F Neurath
(MF)
H U Prokosch
(HU)
J Schmid
(J)
M Vetter
(M)
C Willam
(C)
K Wolf
(K)
C Arendt
(C)
C Bellinghausen
(C)
S Cremer
(S)
A Groh
(A)
A Gruenewaldt
(A)
Y Khodamoradi
(Y)
S Klinsing
(S)
M Vehreschild
(M)
T Vogl
(T)
M Addo
(M)
M Almahfoud
(M)
A L F Engels
(ALF)
D Jarczak
(D)
M Kerinn
(M)
S Kluge
(S)
R Kobbe
(R)
S Petereit
(S)
C Schlesner
(C)
T Zeller
(T)
R Baber
(R)
S Bercker
(S)
N Krug
(N)
S D Mueller
(SD)
H Wirtz
(H)
G Boeckel
(G)
J A Meier
(JA)
T Nowacki
(T)
P R Tepasse
(PR)
R Vollenberg
(R)
C Wilms
(C)
E Dahl
(E)
N Marx
(N)
D Mueller-Wieland
(D)
J Wipperfuerth
(J)
C Brochhausen-Delius
(C)
R Burkhardt
(R)
M Feustel
(M)
O Haag
(O)
S Hansch
(S)
M Malfertheiner
(M)
T Niedermair
(T)
P Schuster
(P)
S Wallner
(S)
S Cleef
(S)
A Friedrichs
(A)
N Kaeding
(N)
M Koerner
(M)
C Kujat
(C)
M Oberlaender
(M)
D Pape
(D)
M Plagge
(M)
J Rupp
(J)
D Schunk
(D)
S Cleef
(S)
A Friedrichs
(A)
N Kaeding
(N)
M Koerner
(M)
C Kujat
(C)
M Oberlaender
(M)
D Pape
(D)
M Plagge
(M)
J Rupp
(J)
D Schunk
(D)
W Barkey
(W)
J Erber
(J)
L Fricke
(L)
J Lieb
(J)
T Michler
(T)
L Mueller
(L)
J Schneider
(J)
C Spinner
(C)
C Winter
(C)
M Bitzer
(M)
S Bunk
(S)
S Göpel
(S)
H Haeberle
(H)
K Kienzle
(K)
H Mahrhofer
(H)
N Malek
(N)
P Rosenberger
(P)
C Struemper
(C)
F Trauner
(F)
S Frantz
(S)
A Frey
(A)
K Haas
(K)
C Haertel
(C)
J Herrmann
(J)
N Isberner
(N)
J Liese
(J)
P Meybohm
(P)
J Schmidt
(J)
P Schulze
(P)
F Brinkmann
(F)
Y Brueggemann
(Y)
T Gambichler
(T)
K Hellwig
(K)
T Luecke
(T)
A Reinacher-Schick
(A)
W E Schmidt
(WE)
C Schuette
(C)
E Steinmann
(E)
C Torres Reyes
(C)
A Hafke
(A)
G Hermanns
(G)
S Y Nussbeck
(SY)
M Santibanez-Santana
(M)
S Zeh
(S)
L Brochhagen
(L)
S Dolff
(S)
C Elsner
(C)
A Krawczyk
(A)
R J Madel
(RJ)
M Otte
(M)
O Witzke
(O)
K Becker
(K)
M Doerr
(M)
M Nauck
(M)
N Piasta
(N)
C Schaefer
(C)
E Schaefer
(E)
M Schattschneider
(M)
C Scheer
(C)
D Stahl
(D)
A Arlt
(A)
F Griesinger
(F)
U Guenther
(U)
A Hamprecht
(A)
K Juergens
(K)
A Kluge
(A)
C Meinhardt
(C)
K Meinhardt
(K)
A Petersmann
(A)
R Prenzel
(R)
M Brechtel
(M)
M Laugwitz
(M)
C Lee
(C)
G Sauer
(G)
N Schulze
(N)
K Seibel
(K)
M Stecher
(M)
M Hagen
(M)
J Schneider
(J)
S Sikdar
(S)
C Weismantel
(C)
L Wolf
(L)
K Günther
(K)
J Haug
(J)
F Haug
(F)
C Fiessler
(C)
P U Heuschmann
(PU)
L Schmidbauer
(L)
S Jiru-Hillmann
(S)
T Bahls
(T)
W Hoffmann
(W)
M Nauck
(M)
C Schaefer
(C)
M Schattschneider
(M)
D Stahl
(D)
H Valentin
(H)
I Chaplinskaya
(I)
S Hanß
(S)
D Krefting
(D)
C Pape
(C)
M Rainers
(M)
A Schoneberg
(A)
N Weinert
(N)
M Kraus
(M)
B Lorenz-Depiereux
(B)
R Lorbeer
(R)
J Schaller
(J)
J Fricke
(J)
L Krist
(L)
M Rönnefarth
(M)
S Schmidt
(S)
T Bahmer
(T)
A Hermes
(A)
M Krawczak
(M)
W Lieb
(W)
S Schreiber
(S)
T Tamminga
(T)
S Herold
(S)
P Heuschmann
(P)
R Heyder
(R)
W Hoffmann
(W)
T Illig
(T)
S Schreiber
(S)
M Witzenrath
(M)
Informations de copyright
© 2024. The Author(s).
Références
Lemhöfer C, Best N, Gutenbrunner C, Loudovici-Krug D, Teixido L, Sturm C. Gefühlte und reale Arbeitsfähigkeit von Patient*innen mit Post-COVID Symptomatik nach mildem Akutverlauf: eine Analyse des Rehabilitation Needs Questionnaire (RehabNeQ). Phys Med Rehabil Kurortmed. 2022;32:151–8. https://doi.org/10.1055/a-1674-8044 .
doi: 10.1055/a-1674-8044
Malik P, Patel K, Pinto C, Jaiswal R, Tirupathi R, Pillai S, et al. Post-acute COVID-19 syndrome (PCS) and health-related quality of life (HRQoL)-A systematic review and meta-analysis. J Med Virol. 2022;94:253–62. https://doi.org/10.1002/jmv.27309 .
doi: 10.1002/jmv.27309
pubmed: 34463956
World Health Organization. Post COVID-19 condition (Long COVID). https://www.who.int/europe/news-room/fact-sheets/item/post-covid-19-condition . Accessed 17 Aug 2023.
National Institute for Health and Care Excellence (NICE), Scottish Intercollegiate Guidelines Network (SIGN) and Royal College of General Practitioners. Guideline COVID-19 rapid guideline: managing the long-term effects of COVID-19 2022.
Centers for Disease Control and Prevention. Long COVID or Post-COVID Conditions. https://www.cdc.gov/coronavirus/2019-ncov/long-term-effects/index.html . Accessed 16 Oct 2023.
Chaichana U, Man KKC, Chen A, Wong ICK, George J, Wilson P, et al. Definition of Post–COVID-19 condition among published research studies. JAMA Netw Open. 2023;6: e235856. https://doi.org/10.1001/jamanetworkopen.2023.5856 .
doi: 10.1001/jamanetworkopen.2023.5856
pubmed: 37017970
pmcid: 10077105
Haslam A, Olivier T, Prasad V. The definition of long COVID used in interventional studies. Eur J Clin Invest. 2023; 00:e13989. https://doi.org/10.1111/eci.13989 .
doi: 10.1111/eci.13989
pubmed: 36964995
Lemhöfer C, Appel KS, Häuser W, Hettich N, Kohls M, Polidori MC. Post COVID – Just a matter of definition? Dtsch Med Wochenschr. 2022;147:1391–7. https://doi.org/10.1055/a-1940-1222 .
doi: 10.1055/a-1940-1222
pubmed: 36279865
O’Mahoney LL, Routen A, Gillies C, Ekezie W, Welford A, Zhang A, et al. The prevalence and long-term health effects of Long Covid among hospitalised and non-hospitalised populations: a systematic review and meta-analysis. EClinicalMedicine. 2023;55: 101762. https://doi.org/10.1016/j.eclinm.2022.101762 .
doi: 10.1016/j.eclinm.2022.101762
pubmed: 36474804
Morin CM, Bjorvatn B, Chung F, Holzinger B, Partinen M, Penzel T, et al. Insomnia, anxiety, and depression during the COVID-19 pandemic: an international collaborative study. Sleep Med. 2021;87:38–45. https://doi.org/10.1016/j.sleep.2021.07.035 .
doi: 10.1016/j.sleep.2021.07.035
pubmed: 34508986
pmcid: 8425785
Sepúlveda-Loyola W, Rodríguez-Sánchez I, Pérez-Rodríguez P, Ganz F, Torralba R, Oliveira DV, et al. Impact of social isolation due to COVID-19 on health in older people: mental and physical effects and recommendations. J Nutr Health Aging. 2020;24:938–47. https://doi.org/10.1007/s12603-020-1469-2 .
doi: 10.1007/s12603-020-1469-2
pubmed: 33155618
pmcid: 7597423
Ballering AV, van Zon SKR, Olde Hartman TC, Rosmalen JGM. Persistence of somatic symptoms after COVID-19 in the Netherlands: an observational cohort study. Lancet. 2022;400:452–61. https://doi.org/10.1016/S0140-6736(22)01214-4 .
doi: 10.1016/S0140-6736(22)01214-4
pubmed: 35934007
pmcid: 9352274
Gentilotti E, Górska A, Tami A, Gusinow R, Mirandola M, Rodríguez Baño J, et al. Clinical phenotypes and quality of life to define post-COVID-19 syndrome: a cluster analysis of the multinational, prospective ORCHESTRA cohort. EClinicalMedicine. 2023;62: 102107. https://doi.org/10.1016/j.eclinm.2023.102107 .
doi: 10.1016/j.eclinm.2023.102107
pubmed: 37654668
pmcid: 10466236
Bahmer T, Borzikowsky C, Lieb W, Horn A, Krist L, Fricke J, et al. Severity, predictors and clinical correlates of Post-COVID syndrome (PCS) in Germany: a prospective, multi-centre, population-based cohort study. EClinicalMedicine. 2022;51: 101549. https://doi.org/10.1016/j.eclinm.2022.101549 .
doi: 10.1016/j.eclinm.2022.101549
pubmed: 35875815
pmcid: 9289961
Thaweethai T, Jolley SE, Karlson EW, Levitan EB, Levy B, McComsey GA, et al. Development of a definition of postacute sequelae of SARS-CoV-2 infection. JAMA. 2023;329:1934–46. https://doi.org/10.1001/jama.2023.8823 .
doi: 10.1001/jama.2023.8823
pubmed: 37278994
pmcid: 10214179
Klok FA, Boon GJAM, Barco S, Endres M, Geelhoed JJM, Knauss S, et al. The Post-COVID-19 Functional Status scale: a tool to measure functional status over time after COVID-19. Eur Respir J. 2020;56:2001494. https://doi.org/10.1183/13993003.01494-2020 .
doi: 10.1183/13993003.01494-2020
pubmed: 32398306
pmcid: 7236834
Schons M, Pilgram L, Reese J-P, Stecher M, Anton G, Appel KS, et al. The German National Pandemic Cohort Network (NAPKON): rationale, study design and baseline characteristics. Eur J Epidemiol. 2022;37:849–70. https://doi.org/10.1007/s10654-022-00896-z .
doi: 10.1007/s10654-022-00896-z
pubmed: 35904671
pmcid: 9336157
Davis HE, Assaf GS, McCorkell L, Wei H, Low RJ, Re’em Y, et al. Characterizing long COVID in an international cohort: 7 months of symptoms and their impact. EClinicalMedicine. 2021;38: 101019. https://doi.org/10.1016/j.eclinm.2021.101019 .
doi: 10.1016/j.eclinm.2021.101019
pubmed: 34308300
pmcid: 8280690
Hartung TJ, Neumann C, Bahmer T, Chaplinskaya-Sobol I, Endres M, Geritz J, et al. Fatigue and cognitive impairment after COVID-19: a prospective multicentre study. EClinicalMedicine. 2022;53: 101651. https://doi.org/10.1016/j.eclinm.2022.101651 .
doi: 10.1016/j.eclinm.2022.101651
pubmed: 36133318
pmcid: 9482331
Jackson C. The Chalder Fatigue Scale (CFQ 11). Occup Med (Lond). 2015;65:86. https://doi.org/10.1093/occmed/kqu168 .
doi: 10.1093/occmed/kqu168
pubmed: 25559796
HealthMeasures. PROMIS® Score Cut Points. https://www.healthmeasures.net/score-and-interpret/interpret-scores/promis/promis-score-cut-points . Accessed 16 Oct 2023.
HealthMeasures. User Manual and Scoring Instructions - PROMIS Fatigue. https://www.healthmeasures.net/images/PROMIS/manuals/Scoring_Manual_Only/PROMIS_Fatigue_User_Manual_and_Scoring_Instructions_02202023.pdf . Accessed 16 Oct 2023.
HealthMeasures. PROMIS Dyspnea Scoring Manual. https://www.healthmeasures.net/images/PROMIS/manuals/Scoring_Manuals_/PROMIS_Dyspnea_Scoring_Manual.pdf . Accessed 16 Oct 2023.
HealthMeasures. PROMIS Sleep Scoring Manual. https://www.healthmeasures.net/images/PROMIS/manuals/Scoring_Manual_Only/PROMIS_Sleep_Scoring_Manual_03June2022.pdf . Accessed 16 Oct 2023.
HealthMeasures. PROMIS Cognitive Function Scoring Manual. https://www.healthmeasures.net/images/PROMIS/manuals/Scoring_Manual_Only/PROMIS_Cognitive_Function_Scoring_Manual_03June2022.pdf . Accessed 16 Oct 2023.
HealthMeasures. Ability to Participate in Social Roles and Activites Scoring Manual. https://www.healthmeasures.net/images/PROMIS/manuals/Scoring_Manual_Only/PROMIS_Ability_to_Participate_in_Social_Roles_and_Activities_Scoring_Manual_03June2022.pdf . Accessed 16 Oct 2023.
HealthMeasures. User Manual and Scoring Instructions PROMIS Physical Function. https://www.healthmeasures.net/images/PROMIS/manuals/Scoring_Manual_Only/PROMIS_Physical_Function_User_Manual_and_Scoring_Instructions_02202023.pdf . Accessed 16 Oct 2023.
Nürnberger C, Kohls M, Rainers M, Miljukov O. epicodr: Primary Coding for NAPKON data; 2023. https://nukleus-ecu.github.io/epicodr/index.html . Accessed 16 Oct 2023.
Fraser M, Jagtar SN. eq5d: Methods for Analysing 'EQ-5D' Data and Calculating 'EQ-5D' Index Scores; 2023. https://cran.r-project.org/web/packages/eq5d/index.html . Accessed 16 Oct 2023.
Cohen J. Statistical power analysis for the behavioral sciences. Hillsdale: L. Erlbaum Associates; 1988.
Adeloye D, Elneima O, Daines L, Poinasamy K, Quint JK, Walker S, et al. The long-term sequelae of COVID-19: an international consensus on research priorities for patients with pre-existing and new-onset airways disease. Lancet Respir Med. 2021;9:1467–78. https://doi.org/10.1016/S2213-2600(21)00286-1 .
doi: 10.1016/S2213-2600(21)00286-1
pubmed: 34416191
pmcid: 8372501
Sivan M, Preston N, Parkin A, Makower S, Gee J, Ross D, et al. The modified COVID-19 Yorkshire Rehabilitation Scale (C19-YRSm) patient-reported outcome measure for Long Covid or Post-COVID-19 syndrome. J Med Virol. 2022;94:4253–64. https://doi.org/10.1002/jmv.27878 .
doi: 10.1002/jmv.27878
pubmed: 35603810
pmcid: 9348420
Kyte DG, Calvert M, van der Wees PJ, ten Hove R, Tolan S, Hill JC. An introduction to patient-reported outcome measures (PROMs) in physiotherapy. Physiotherapy. 2015;101(2):119–25. https://doi.org/10.1016/j.physio.2014.11.003 .
doi: 10.1016/j.physio.2014.11.003
pubmed: 25620440
Lemhöfer C, Bahmer T, Baumbach P, Besteher B, Boekel A, Finke K, et al. Variations and predictors of Post-covid syndrome severity in patients attending a Post-COVID outpatient clinic. J Clin Med. 2023;12:4013. https://doi.org/10.3390/jcm12124013 .
doi: 10.3390/jcm12124013
pubmed: 37373706
pmcid: 10298907
Nittas V, Gao M, West EA, Ballouz T, Menges D, Hanson SW, et al. Long COVID through a public health lens: an umbrella review. Public Health Rev. 2022;43:1604501. https://doi.org/10.3389/phrs.2022.1604501 .
doi: 10.3389/phrs.2022.1604501
pubmed: 35359614
pmcid: 8963488
Polack FP, Thomas SJ, Kitchin N, Absalon J, Gurtman A, et al. Safety and efficacy of the BNT162b2 mRNA Covid-19 Vaccine. E Engl J Med. 2020;383:2603–15. https://doi.org/10.1056/NEJMoa2034577 .
doi: 10.1056/NEJMoa2034577
El Sahly HM, Baden LR, Essink B, Doblecki-Lewis S, Martin JM, Anderson EJ, et al. Efficacy of the mRNA-1273 SARS-CoV-2 vaccine at completion of blinded phase. N Engl J Med. 2021;385:1774–85. https://doi.org/10.1056/NEJMoa2113017 .
doi: 10.1056/NEJMoa2113017
pubmed: 34551225
Davis HE, McCorkell L, Vogel JM, Topol EJ. Long COVID: major findings, mechanisms and recommendations. Nat Rev Microbiol. 2023;21:133–46. https://doi.org/10.1038/s41579-022-00846-2 .
doi: 10.1038/s41579-022-00846-2
pubmed: 36639608
pmcid: 9839201
Tabacof L, Nicolau E, Rivera A, Putrino D. Post-COVID conditions and burden of disease. Phys Med Rehabil Clin N Am. 2023;34(3):499–511. https://doi.org/10.1016/j.pmr.2023.04.007 .
doi: 10.1016/j.pmr.2023.04.007
pubmed: 37419527
Zuin M, Mazzitelli M, Cattelan A. Long-COVID: is it time to revise the definition. J Med Virol. 2023;95: e29011. https://doi.org/10.1002/jmv.29011 .
doi: 10.1002/jmv.29011
pubmed: 37526385
Vrettou CS, Mantziou V, Vassiliou AG, Orfanos SE, Kotanidou A, Dimopoulou I. Post-intensive care syndrome in survivors from critical illness including COVID-19 patients: a narrative review. Life. 2022;12(1):107. https://doi.org/10.3390/life12010107 .
doi: 10.3390/life12010107
pubmed: 35054500
pmcid: 8778667