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Core Outcome Set for Research and Clinical Practice in Post COVID-19 Condition (Long COVID): An International Delphi Consensus Study ‘PC-COS’

14 Pages Posted: 31 Jan 2022

See all articles by Daniel Munblit

Daniel Munblit

M. Sechenov First Moscow State Medical University (Sechenov University) - Department of Paediatrics and Paediatric Infectious Diseases

Timothy Nicholson

King's College London

Athena Akrami

University College London - Patient-Led Research Collaborative

Christian Apfelbacher

Otto von Guericke University Magdeburg - Institute of Social Medicine and Health Systems Research

Jessica Chen

Imperial College London

Wouter De Groote

affiliation not provided to SSRN

Janet Diaz

World Health Organization (WHO) - Department of Country Readiness Strengthening

Sarah L. Gorst

University of Liverpool

Nicola Harman

University of Liverpool

Alisa Kokorina

affiliation not provided to SSRN

Piero L. Olliaro

University of Oxford - Nuffield Department of Medicine

Callum Parr

affiliation not provided to SSRN

Jacobus Preller

Cambridge University Hospitals - MRCP

Nicoline Schiess

World Health Organization (WHO) - Brain Health Unit

Jochen Schmitt

affiliation not provided to SSRN

Nina Seylanova

affiliation not provided to SSRN

Frances Simpson

Coventry University

Allison Tong

affiliation not provided to SSRN

Dale M. Needham

Johns Hopkins University - Outcomes After Critical Illness and Surgery (OACIS) Research Group

Paula R. Williamson

University of Liverpool

PC-COS Project Steering Committee

Independent

More...

Abstract

Background: Recent data suggest that many people experience Post COVID-19 Condition (Long COVID) following the acute phase of the SaRS CoV-2 infection. At present there is no agreement on what patient health outcomes should be measured in Post COVID-19 Condition. We aimed to identify core outcomes for Post COVID-19 Condition that stakeholders considered critical to assess in all research studies and clinical practice.

Methods: We conducted a multi-step study: (1) review of outcomes reported in studies of Post COVID-19 Condition to develop a list of potential core outcomes; (2) outcomes were then grouped, using the COMET taxonomy, to present in a consensus process; (3) a two-round online international modified Delphi consensus process, including 3 stakeholder groups (‘people with Post COVID-19 Condition and their carers’, ‘healthcare professionals and researchers’ and ‘healthcare professionals and researchers with Post COVID-19 Condition) to prioritise outcomes; and (4) an international online consensus meeting to finalize the core outcome set. Consensus ‘in’ was defined, a priori, as 80% or more of each stakeholder group rating an outcome as critical (‘7-9’ on a 9-point scale). Patient engagement and global outreach activities were undertaken at all stages of the project.

Findings: 1535 participants from 71 countries, representing six continents, were involved in the online modified Delphi process, with 1148 participating in both rounds (75% completion rate). Eleven of 24 outcomes met consensus ‘in’ criteria after the two Delphi rounds and consensus meeting: fatigue or exhaustion; pain; post-exertion symptoms; work/occupational and study changes; survival; and “functioning, symptoms and conditions” for each of the following outcomes: cardiovascular, respiratory, nervous system, cognition, mental and physical. ‘Recovery’ outcome was added ‘a-priori’ as a part of previously published COS on COVID-19.

Interpretation: This international study resulted in the development of a COS for Post COVID-19 Condition using a rigorous methodology. The generated consensus-based list of core outcomes should be assessed in clinical research and practice settings. The next step for the development of this COS will be to determine which measurement instruments best measure these outcomes.

Funding Information: Funding by the National Institute for Health Research (NIHR) (Grant COV-LT2-0072) supporting the second stage of the process.

Declaration of Interests: None to declare.

Ethics Approval Statement: Ethical approval for the study was given by the UK Health Research Authority and by the South West - Cornwall & Plymouth Research Ethics Committee (REC number 21/SW/0109).

Keywords: Covid-19, COVID-19 sequalae, Long COVID, Post-Acute Sequelae of SARS-CoV-2 infection, PASC, post-COVID-19 condition, outcomes, Core Outcome Set.

Suggested Citation

Munblit, Daniel and Nicholson, Timothy and Akrami, Athena and Apfelbacher, Christian and Chen, Jessica and De Groote, Wouter and Diaz, Janet and Gorst, Sarah L. and Harman, Nicola and Kokorina, Alisa and Olliaro, Piero L. and Parr, Callum and Preller, Jacobus and Schiess, Nicoline and Schmitt, Jochen and Seylanova, Nina and Simpson, Frances and Tong, Allison and Needham, Dale M. and Williamson, Paula R. and Committee, PC-COS Project Steering, Core Outcome Set for Research and Clinical Practice in Post COVID-19 Condition (Long COVID): An International Delphi Consensus Study ‘PC-COS’. Available at SSRN: https://ssrn.com/abstract=4017375. or http://dx.doi.org/10.2139/ssrn.4017375

Daniel Munblit (Contact Author)

M. Sechenov First Moscow State Medical University (Sechenov University) - Department of Paediatrics and Paediatric Infectious Diseases ( email )

Moscow
Russia

Timothy Nicholson

King's College London ( email )

Strand
London, England WC2R 2LS
United Kingdom

Athena Akrami

University College London - Patient-Led Research Collaborative ( email )

United Kingdom

Christian Apfelbacher

Otto von Guericke University Magdeburg - Institute of Social Medicine and Health Systems Research ( email )

Magdeburg
Germany

Jessica Chen

Imperial College London ( email )

South Kensington Campus
Exhibition Road
London, SW7 2AZ
United Kingdom

Wouter De Groote

affiliation not provided to SSRN ( email )

No Address Available

Janet Diaz

World Health Organization (WHO) - Department of Country Readiness Strengthening ( email )

Geneva
Switzerland

Sarah L. Gorst

University of Liverpool ( email )

Chatham Street
Liverpool, L69 7ZA
United Kingdom

Nicola Harman

University of Liverpool ( email )

Chatham Street
Liverpool, L69 7ZA
United Kingdom

Alisa Kokorina

affiliation not provided to SSRN ( email )

No Address Available

Piero L. Olliaro

University of Oxford - Nuffield Department of Medicine ( email )

Old Road Campus
Roosevelt Drive
Oxford, OX3 7FZ
United Kingdom

Callum Parr

affiliation not provided to SSRN ( email )

No Address Available

Jacobus Preller

Cambridge University Hospitals - MRCP ( email )

Hills Road
Cambridge, CB2 0QQ
United Kingdom

Nicoline Schiess

World Health Organization (WHO) - Brain Health Unit ( email )

Geneva
Switzerland

Jochen Schmitt

affiliation not provided to SSRN ( email )

No Address Available

Nina Seylanova

affiliation not provided to SSRN ( email )

No Address Available

Frances Simpson

Coventry University ( email )

Priory Street
Coventry, CV1 5FB
United Kingdom

Allison Tong

affiliation not provided to SSRN ( email )

No Address Available

Dale M. Needham

Johns Hopkins University - Outcomes After Critical Illness and Surgery (OACIS) Research Group ( email )

Baltimore, MD
United States

Paula R. Williamson

University of Liverpool ( email )

Chatham Street
Liverpool, L69 7ZA
United Kingdom

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