Studying the post-COVID-19 condition: research challenges, strategies, and importance of Core Outcome Set development

Daniel Munblit^#^{1

2

3}, Timothy R Nicholson^#⁴, Dale M Needham^#^{5

6

7}, Nina Seylanova^#⁸, Callum Parr⁹, Jessica Chen⁹, Alisa Kokorina¹⁰, Louise Sigfrid¹¹, Danilo Buonsenso^{12

13

14}, Shinjini Bhatnagar¹⁵, Ramachandran Thiruvengadam¹⁵, Ann M Parker^{5

6}, Jacobus Preller¹⁶, Sergey Avdeev¹⁷, Frederikus A Klok¹⁸, Allison Tong¹⁹, Janet V Diaz²⁰, Wouter De Groote²⁰, Nicoline Schiess²¹, Athena Akrami^{22

23}, Frances Simpson²⁴, Piero Olliaro²⁵, Christian Apfelbacher²⁶, Regis Goulart Rosa^{27

28}, Jennifer R Chevinsky^{29

30}, Sharon Saydah^{29

31}, Jochen Schmitt³², Alla Guekht^{33

10}, Sarah L Gorst³⁴, Jon Genuneit³⁵, Luis Felipe Reyes^{36

37}, Alan Asmanov³⁸, Margaret E O'Hara³⁹, Janet T Scott⁴⁰, Melina Michelen^{25

41}, Charitini Stavropoulou⁴¹, John O Warner⁴², Margaret Herridge^{43

44}, Paula R Williamson^#⁴⁵

Affiliations

¹ Department of Paediatrics and Paediatric Infectious Diseases, Institute of Child's Health, Sechenov First Moscow State Medical University (Sechenov University), Moscow, Russia. daniel.munblit08@imperial.ac.uk.
² Inflammation, Repair and Development Section, National Heart and Lung Institute, Faculty of Medicine, Imperial College London, London, UK. daniel.munblit08@imperial.ac.uk.
³ Research and Clinical Center for Neuropsychiatry, Moscow, Russia. daniel.munblit08@imperial.ac.uk.
⁴ Institute of Psychiatry, Psychology and Neuroscience, King's College London, London, UK.
⁵ Outcomes After Critical Illness and Surgery (OACIS) Research Group, Johns Hopkins University, Baltimore, MD, USA.
⁶ Pulmonary and Critical Care Medicine, Department of Medicine, Johns Hopkins University School of Medicine, Baltimore, MD, USA.
⁷ Physical Medicine and Rehabilitation, Johns Hopkins University School of Medicine, Baltimore, MD, USA.
⁸ Sechenov Biomedical Science and Technology Park, Sechenov First Moscow State Medical University (Sechenov University), Moscow, Russia.
⁹ Faculty of Medicine, Imperial College London, London, UK.
¹⁰ Pirogov Russian National Research Medical University, Moscow, Russia.
¹¹ ISARIC Global Support Centre, Centre for Tropical Medicine and Global Health, University of Oxford, Oxford, UK.
¹² Department of Woman and Child Health and Public Health, Fondazione Policlinico Universitario A. Gemelli IRCCS, Rome, Italy.
¹³ Dipartimento di Scienze Biotecnologiche di Base, Cliniche Intensivologiche e Perioperatorie, Università Cattolica del Sacro Cuore, Rome, Italy.
¹⁴ Global Health Research Institute, Istituto di Igiene, Università Cattolica del Sacro Cuore, Roma, Italy.
¹⁵ Maternal and Child Health Program, Translational Health Science and Technology Institute, Faridabad, Delhi, National Capital Region, India.
¹⁶ Clinical Management, WHO, WHE, Geneva, Switzerland.
¹⁷ Department of Pulmonology, Sechenov First Moscow State Medical University (Sechenov University), Moscow, Russia.
¹⁸ Department of Medicine - Thrombosis and Hemostasis, Leiden University Medical Center, Leiden, the Netherlands.
¹⁹ Sydney School of Public Health, The University of Sydney, Sydney, Australia.
²⁰ NCD Department, Rehabilitation Programme, WHO, Geneva, Switzerland.
²¹ WHO Brain Health Unit, Geneva, Switzerland.
²² Sainsbury Wellcome Centre, UCL, London, UK.
²³ Patient-Led Research Collaborative, Washington, DC, USA.
²⁴ Coventry University, Coventry, UK.
²⁵ ISARIC Global Support Centre, Nuffield Department of Medicine, University of Oxford, Oxford, UK.
²⁶ Institute of Social Medicine and Health Systems Research, Faculty of Medicine, Otto von Guericke University Magdeburg, Magdeburg, Germany.
²⁷ Critical Care Department, Hospital Moinhos de Vento, Porto Alegre, Brazil.
²⁸ Brazilian Research in Intensive Care Network (BRICNet), São Paulo, Brazil.
²⁹ COVID-19 Response Team, Centers for Disease Control and Prevention, Atlanta, GA, USA.
³⁰ Epidemic Intelligence Service, Centers for Disease Control and Prevention, Atlanta, GA, USA.
³¹ Respiratory Viruses Branch, Division of Viral Diseases, Centers for Disease Control and Prevention, Atlanta, GA, USA.
³² Center for Evidence-Based Healthcare, Medical Faculty Carl Gustav Carus, TU Dresden, Dresden, Germany.
³³ Research and Clinical Center for Neuropsychiatry, Moscow, Russia.
³⁴ Department of Health Data Science, University of Liverpool, Liverpool, UK.
³⁵ Paediatric Epidemiology, Department of Pediatrics, Medical Faculty, Leipzig University, Leipzig, Germany.
³⁶ Universidad de La Sabana, Chía, Colombia.
³⁷ Clínica Universidad de La Sabana, Chía, Colombia.
³⁸ The Research and Clinical Institute for Pediatrics named after Academician Yuri Veltischev of the Pirogov Russian National Research Medical University, Moscow, Russia.
³⁹ Long COVID Support, London, UK.
⁴⁰ MRC-University of Glasgow, Centre for Virus Research, Glasgow, UK.
⁴¹ School of Health Sciences, City, University of London, London, UK.
⁴² Paediatric Infectious Diseases, Imperial College Healthcare NHS Trust, London, UK.
⁴³ Interdepartmental Division of Critical Care Medicine, University of Toronto, Toronto, ON, Canada.
⁴⁴ Department of Medicine, University Health Network, Toronto, ON, Canada.
⁴⁵ MRC/NIHR Trials Methodology Research Partnership, Department of Health Data Science, University of Liverpool (a member of Liverpool Health Partners), Liverpool, UK.

^# Contributed equally.

PMID: 35114994
PMCID: PMC8813480
DOI: 10.1186/s12916-021-02222-y

Studying the post-COVID-19 condition: research challenges, strategies, and importance of Core Outcome Set development

Daniel Munblit et al. BMC Med. 2022.

. 2022 Feb 4;20(1):50.

doi: 10.1186/s12916-021-02222-y.

Authors

Affiliations

¹ Department of Paediatrics and Paediatric Infectious Diseases, Institute of Child's Health, Sechenov First Moscow State Medical University (Sechenov University), Moscow, Russia. daniel.munblit08@imperial.ac.uk.
² Inflammation, Repair and Development Section, National Heart and Lung Institute, Faculty of Medicine, Imperial College London, London, UK. daniel.munblit08@imperial.ac.uk.
³ Research and Clinical Center for Neuropsychiatry, Moscow, Russia. daniel.munblit08@imperial.ac.uk.
⁴ Institute of Psychiatry, Psychology and Neuroscience, King's College London, London, UK.
⁵ Outcomes After Critical Illness and Surgery (OACIS) Research Group, Johns Hopkins University, Baltimore, MD, USA.
⁶ Pulmonary and Critical Care Medicine, Department of Medicine, Johns Hopkins University School of Medicine, Baltimore, MD, USA.
⁷ Physical Medicine and Rehabilitation, Johns Hopkins University School of Medicine, Baltimore, MD, USA.
⁸ Sechenov Biomedical Science and Technology Park, Sechenov First Moscow State Medical University (Sechenov University), Moscow, Russia.
⁹ Faculty of Medicine, Imperial College London, London, UK.
¹⁰ Pirogov Russian National Research Medical University, Moscow, Russia.
¹¹ ISARIC Global Support Centre, Centre for Tropical Medicine and Global Health, University of Oxford, Oxford, UK.
¹² Department of Woman and Child Health and Public Health, Fondazione Policlinico Universitario A. Gemelli IRCCS, Rome, Italy.
¹³ Dipartimento di Scienze Biotecnologiche di Base, Cliniche Intensivologiche e Perioperatorie, Università Cattolica del Sacro Cuore, Rome, Italy.
¹⁴ Global Health Research Institute, Istituto di Igiene, Università Cattolica del Sacro Cuore, Roma, Italy.
¹⁵ Maternal and Child Health Program, Translational Health Science and Technology Institute, Faridabad, Delhi, National Capital Region, India.
¹⁶ Clinical Management, WHO, WHE, Geneva, Switzerland.
¹⁷ Department of Pulmonology, Sechenov First Moscow State Medical University (Sechenov University), Moscow, Russia.
¹⁸ Department of Medicine - Thrombosis and Hemostasis, Leiden University Medical Center, Leiden, the Netherlands.
¹⁹ Sydney School of Public Health, The University of Sydney, Sydney, Australia.
²⁰ NCD Department, Rehabilitation Programme, WHO, Geneva, Switzerland.
²¹ WHO Brain Health Unit, Geneva, Switzerland.
²² Sainsbury Wellcome Centre, UCL, London, UK.
²³ Patient-Led Research Collaborative, Washington, DC, USA.
²⁴ Coventry University, Coventry, UK.
²⁵ ISARIC Global Support Centre, Nuffield Department of Medicine, University of Oxford, Oxford, UK.
²⁶ Institute of Social Medicine and Health Systems Research, Faculty of Medicine, Otto von Guericke University Magdeburg, Magdeburg, Germany.
²⁷ Critical Care Department, Hospital Moinhos de Vento, Porto Alegre, Brazil.
²⁸ Brazilian Research in Intensive Care Network (BRICNet), São Paulo, Brazil.
²⁹ COVID-19 Response Team, Centers for Disease Control and Prevention, Atlanta, GA, USA.
³⁰ Epidemic Intelligence Service, Centers for Disease Control and Prevention, Atlanta, GA, USA.
³¹ Respiratory Viruses Branch, Division of Viral Diseases, Centers for Disease Control and Prevention, Atlanta, GA, USA.
³² Center for Evidence-Based Healthcare, Medical Faculty Carl Gustav Carus, TU Dresden, Dresden, Germany.
³³ Research and Clinical Center for Neuropsychiatry, Moscow, Russia.
³⁴ Department of Health Data Science, University of Liverpool, Liverpool, UK.
³⁵ Paediatric Epidemiology, Department of Pediatrics, Medical Faculty, Leipzig University, Leipzig, Germany.
³⁶ Universidad de La Sabana, Chía, Colombia.
³⁷ Clínica Universidad de La Sabana, Chía, Colombia.
³⁸ The Research and Clinical Institute for Pediatrics named after Academician Yuri Veltischev of the Pirogov Russian National Research Medical University, Moscow, Russia.
³⁹ Long COVID Support, London, UK.
⁴⁰ MRC-University of Glasgow, Centre for Virus Research, Glasgow, UK.
⁴¹ School of Health Sciences, City, University of London, London, UK.
⁴² Paediatric Infectious Diseases, Imperial College Healthcare NHS Trust, London, UK.
⁴³ Interdepartmental Division of Critical Care Medicine, University of Toronto, Toronto, ON, Canada.
⁴⁴ Department of Medicine, University Health Network, Toronto, ON, Canada.
⁴⁵ MRC/NIHR Trials Methodology Research Partnership, Department of Health Data Science, University of Liverpool (a member of Liverpool Health Partners), Liverpool, UK.

^# Contributed equally.

PMID: 35114994
PMCID: PMC8813480
DOI: 10.1186/s12916-021-02222-y

Abstract

Background: A substantial portion of people with COVID-19 subsequently experience lasting symptoms including fatigue, shortness of breath, and neurological complaints such as cognitive dysfunction many months after acute infection. Emerging evidence suggests that this condition, commonly referred to as long COVID but also known as post-acute sequelae of SARS-CoV-2 infection (PASC) or post-COVID-19 condition, could become a significant global health burden.

Main text: While the number of studies investigating the post-COVID-19 condition is increasing, there is no agreement on how this new disease should be defined and diagnosed in clinical practice and what relevant outcomes to measure. There is an urgent need to optimise and standardise outcome measures for this important patient group both for clinical services and for research and to allow comparing and pooling of data.

Conclusions: A Core Outcome Set for post-COVID-19 condition should be developed in the shortest time frame possible, for improvement in data quality, harmonisation, and comparability between different geographical locations. We call for a global initiative, involving all relevant partners, including, but not limited to, healthcare professionals, researchers, methodologists, patients, and caregivers. We urge coordinated actions aiming to develop a Core Outcome Set (COS) for post-COVID-19 condition in both the adult and paediatric populations.

Keywords: COVID-19; COVID-19 sequalae; Core Outcome Set; Long COVID; Outcomes; PASC; Post-COVID-19 condition; Post-acute sequelae of SARS-CoV-2 infection.

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Conflict of interest statement

DM, TRN, DN, and PW are leading the development of the Core Outcome Set for post-COVID-19 condition as a part of the PC-COS project team. The other authors declare that they have no competing interests.

References

1. World Health Organization. WHO Coronavirus (COVID-19) Dashboard [https://covid19.who.int/]
1. Lerner AM, Robinson DA, Yang L, Williams CF, Newman LM, Breen JJ, Eisinger RW, Schneider JS, Adimora AA, Erbelding EJ. Toward understanding COVID-19 recovery: National Institutes of Health Workshop on Postacute COVID-19. Ann Intern Med. 2021;174(7):999–1003. doi: 10.7326/M21-1043. - DOI - PMC - PubMed
1. World Health Organization. A systematic approach for undertaking a research priority setting exercise [https://apps.who.int/iris/bitstream/handle/10665/334408/9789240009622-en...]
1. The Lancet Facing up to long COVID. Lancet. 2020;396(10266):1861. doi: 10.1016/S0140-6736(20)32662-3. - DOI - PMC - PubMed
1. Meeting the challenge of long COVID. Nat Med 2020, 26(12):1803. - PubMed

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Studying the post-COVID-19 condition: research challenges, strategies, and importance of Core Outcome Set development

Affiliations

Studying the post-COVID-19 condition: research challenges, strategies, and importance of Core Outcome Set development

Authors

Affiliations

Abstract

Conflict of interest statement

References

MeSH terms

Grants and funding

LinkOut - more resources

Full Text Sources

Medical

Miscellaneous