A core outcome set for post-COVID-19 condition in adults for use in clinical practice and research: an international Delphi consensus study

PC-COS project steering committee

doi:10.1016/S2213-2600(22)00169-2

A core outcome set for post-COVID-19 condition in adults for use in clinical practice and research: an international Delphi consensus study

PC-COS project steering committee

Research output: Contribution to journal › Review article › peer-review

122 Citations (Scopus)

Abstract

Health consequences that persist beyond the acute infection phase of COVID-19, termed post-COVID-19 condition (also commonly known as long COVID), vary widely and represent a growing global health challenge. Research on post-COVID-19 condition is expanding but, at present, no agreement exists on the health outcomes that should be measured in people living with the condition. To address this gap, we conducted an international consensus study, which included a comprehensive literature review and classification of outcomes for post-COVID-19 condition that informed a two-round online modified Delphi process followed by an online consensus meeting to finalise the core outcome set (COS). 1535 participants from 71 countries were involved, with 1148 individuals participating in both Delphi rounds. Eleven outcomes achieved consensus for inclusion in the final COS: fatigue; pain; post-exertion symptoms; work or occupational and study changes; survival; and functioning, symptoms, and conditions for each of cardiovascular, respiratory, nervous system, cognitive, mental health, and physical outcomes. Recovery was included a priori because it was a relevant outcome that was part of a previously published COS on COVID-19. The next step in this COS development exercise will be to establish the instruments that are most appropriate to measure these core outcomes. This international consensus-based COS should provide a framework for standardised assessment of adults with post-COVID-19 condition, aimed at facilitating clinical care and research worldwide.

Original language	English
Pages (from-to)	715-724
Number of pages	10
Journal	The Lancet Respiratory Medicine
Volume	10
Issue number	7
DOIs	https://doi.org/10.1016/S2213-2600(22)00169-2
Publication status	Published - Jul 2022

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10.1016/S2213-2600(22)00169-2

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@article{2e2090827cad40b4980f88cd8ee4642c,

title = "A core outcome set for post-COVID-19 condition in adults for use in clinical practice and research: an international Delphi consensus study",

abstract = "Health consequences that persist beyond the acute infection phase of COVID-19, termed post-COVID-19 condition (also commonly known as long COVID), vary widely and represent a growing global health challenge. Research on post-COVID-19 condition is expanding but, at present, no agreement exists on the health outcomes that should be measured in people living with the condition. To address this gap, we conducted an international consensus study, which included a comprehensive literature review and classification of outcomes for post-COVID-19 condition that informed a two-round online modified Delphi process followed by an online consensus meeting to finalise the core outcome set (COS). 1535 participants from 71 countries were involved, with 1148 individuals participating in both Delphi rounds. Eleven outcomes achieved consensus for inclusion in the final COS: fatigue; pain; post-exertion symptoms; work or occupational and study changes; survival; and functioning, symptoms, and conditions for each of cardiovascular, respiratory, nervous system, cognitive, mental health, and physical outcomes. Recovery was included a priori because it was a relevant outcome that was part of a previously published COS on COVID-19. The next step in this COS development exercise will be to establish the instruments that are most appropriate to measure these core outcomes. This international consensus-based COS should provide a framework for standardised assessment of adults with post-COVID-19 condition, aimed at facilitating clinical care and research worldwide.",

author = "{PC-COS project steering committee} and Daniel Munblit and Timothy Nicholson and Athena Akrami and Christian Apfelbacher and Jessica Chen and {De Groote}, Wouter and Diaz, {Janet V.} and Gorst, {Sarah L.} and Nicola Harman and Alisa Kokorina and Piero Olliaro and Callum Parr and Jacobus Preller and Nicoline Schiess and Jochen Schmitt and Nina Seylanova and Frances Simpson and Allison Tong and Needham, {Dale M.} and Williamson, {Paula R.} and Alla Guekht and Semple, {Malcolm “Calum” G.} and Warner, {John O.} and Louise Sigfrid and Scott, {Janet T.} and Audrey DunnGalvin and Jon Genuneit and Danilo Buonsenso and Manoj Sivan and Bob Siegerink and Klok, {Frederikus A.} and Sergey Avdeev and Charitini Stavropoulou and Melina Michelen and Aiyegbusi, {Olalekan Lee} and Melanie Calvert and Hughes, {Sarah E.} and Shamil Haroon and Laura Fregonese and Gail Carson and Samuel Knauss and Margaret O'Hara and John Marshall and Margaret Herridge and Srinivas Murthy and Theo Vos and {Wulf Hanson}, Sarah and Ann Parker and O'Brien, {Kelly K.} and Andrea Lerner",

note = "Funding Information: There was no funding for the first stage of the Post-COVID-19 Condition Core Outcome Set (PC-COS) study; the second stage of the PC-COS study is funded by the UK National Institute for Health and Care Research (NIHR; grant COV-LT2-0072). DM has received grants from the British Embassy in Moscow, the NIHR, and the Russian Foundation for Basic Research. TN and PRW have received funding from the NIHR. We thank all participants of the consensus development process, and particularly the people with lived experience of post-COVID-19 condition and their carers (a full list of participants wishing to be acknowledged is included in appendix 1, pp 45–52 ); WHO for their collaboration; the translators who provided translation of all English materials to four additional languages; Marjorie Williamson, Valeria Sluzhevskaya, Guo Xiao Yuan, and Ilya Kalinin for their assistance with translation; Aleksandra Pokrovskaya and Nile Saunders for their help with preparation of participant information sheets; Mike Clarke for his work as an independent facilitator of the online interactive consensus meeting; Heather Barrington, Core Outcome Measures in Effectiveness Trials (COMET) Patient and Public Coordinator, for delivering the consensus pre-meeting for people with post-COVID-19 condition and their carers; the COMET People and Patient Participation, Involvement and Engagement working group; the COMET Management Group; and Sara Brookes for developing and sharing the slide set used in the pre-meeting. The views expressed in this publication are those of the authors and do not necessarily represent the views of the International Severe Acute Respiratory and Emerging Infection Consortium, the NIHR, or WHO. Funding Information: There was no funding for the first stage of the Post-COVID-19 Condition Core Outcome Set (PC-COS) study; the second stage of the PC-COS study is funded by the UK National Institute for Health and Care Research (NIHR; grant COV-LT2-0072). DM has received grants from the British Embassy in Moscow, the NIHR, and the Russian Foundation for Basic Research. TN and PRW have received funding from the NIHR. We thank all participants of the consensus development process, and particularly the people with lived experience of post-COVID-19 condition and their carers (a full list of participants wishing to be acknowledged is included in appendix 1, pp 45–52); WHO for their collaboration; the translators who provided translation of all English materials to four additional languages; Marjorie Williamson, Valeria Sluzhevskaya, Guo Xiao Yuan, and Ilya Kalinin for their assistance with translation; Aleksandra Pokrovskaya and Nile Saunders for their help with preparation of participant information sheets; Mike Clarke for his work as an independent facilitator of the online interactive consensus meeting; Heather Barrington, Core Outcome Measures in Effectiveness Trials (COMET) Patient and Public Coordinator, for delivering the consensus pre-meeting for people with post-COVID-19 condition and their carers; the COMET People and Patient Participation, Involvement and Engagement working group; the COMET Management Group; and Sara Brookes for developing and sharing the slide set used in the pre-meeting. The views expressed in this publication are those of the authors and do not necessarily represent the views of the International Severe Acute Respiratory and Emerging Infection Consortium, the NIHR, or WHO. Publisher Copyright: {\textcopyright} 2022 World Health Organization. Published by Elsevier Ltd. All rights reserved.",

year = "2022",

month = jul,

doi = "10.1016/S2213-2600(22)00169-2",

language = "English",

volume = "10",

pages = "715--724",

journal = "The Lancet Respiratory Medicine",

issn = "2213-2600",

publisher = "Elsevier Ltd",

number = "7",

}

TY - JOUR

T1 - A core outcome set for post-COVID-19 condition in adults for use in clinical practice and research

T2 - an international Delphi consensus study

AU - PC-COS project steering committee

AU - Munblit, Daniel

AU - Nicholson, Timothy

AU - Akrami, Athena

AU - Apfelbacher, Christian

AU - Chen, Jessica

AU - De Groote, Wouter

AU - Diaz, Janet V.

AU - Gorst, Sarah L.

AU - Harman, Nicola

AU - Kokorina, Alisa

AU - Olliaro, Piero

AU - Parr, Callum

AU - Preller, Jacobus

AU - Schiess, Nicoline

AU - Schmitt, Jochen

AU - Seylanova, Nina

AU - Simpson, Frances

AU - Tong, Allison

AU - Needham, Dale M.

AU - Williamson, Paula R.

AU - Guekht, Alla

AU - Semple, Malcolm “Calum” G.

AU - Warner, John O.

AU - Sigfrid, Louise

AU - Scott, Janet T.

AU - DunnGalvin, Audrey

AU - Genuneit, Jon

AU - Buonsenso, Danilo

AU - Sivan, Manoj

AU - Siegerink, Bob

AU - Klok, Frederikus A.

AU - Avdeev, Sergey

AU - Stavropoulou, Charitini

AU - Michelen, Melina

AU - Aiyegbusi, Olalekan Lee

AU - Calvert, Melanie

AU - Hughes, Sarah E.

AU - Haroon, Shamil

AU - Fregonese, Laura

AU - Carson, Gail

AU - Knauss, Samuel

AU - O'Hara, Margaret

AU - Marshall, John

AU - Herridge, Margaret

AU - Murthy, Srinivas

AU - Vos, Theo

AU - Wulf Hanson, Sarah

AU - Parker, Ann

AU - O'Brien, Kelly K.

AU - Lerner, Andrea

N1 - Funding Information: There was no funding for the first stage of the Post-COVID-19 Condition Core Outcome Set (PC-COS) study; the second stage of the PC-COS study is funded by the UK National Institute for Health and Care Research (NIHR; grant COV-LT2-0072). DM has received grants from the British Embassy in Moscow, the NIHR, and the Russian Foundation for Basic Research. TN and PRW have received funding from the NIHR. We thank all participants of the consensus development process, and particularly the people with lived experience of post-COVID-19 condition and their carers (a full list of participants wishing to be acknowledged is included in appendix 1, pp 45–52 ); WHO for their collaboration; the translators who provided translation of all English materials to four additional languages; Marjorie Williamson, Valeria Sluzhevskaya, Guo Xiao Yuan, and Ilya Kalinin for their assistance with translation; Aleksandra Pokrovskaya and Nile Saunders for their help with preparation of participant information sheets; Mike Clarke for his work as an independent facilitator of the online interactive consensus meeting; Heather Barrington, Core Outcome Measures in Effectiveness Trials (COMET) Patient and Public Coordinator, for delivering the consensus pre-meeting for people with post-COVID-19 condition and their carers; the COMET People and Patient Participation, Involvement and Engagement working group; the COMET Management Group; and Sara Brookes for developing and sharing the slide set used in the pre-meeting. The views expressed in this publication are those of the authors and do not necessarily represent the views of the International Severe Acute Respiratory and Emerging Infection Consortium, the NIHR, or WHO. Funding Information: There was no funding for the first stage of the Post-COVID-19 Condition Core Outcome Set (PC-COS) study; the second stage of the PC-COS study is funded by the UK National Institute for Health and Care Research (NIHR; grant COV-LT2-0072). DM has received grants from the British Embassy in Moscow, the NIHR, and the Russian Foundation for Basic Research. TN and PRW have received funding from the NIHR. We thank all participants of the consensus development process, and particularly the people with lived experience of post-COVID-19 condition and their carers (a full list of participants wishing to be acknowledged is included in appendix 1, pp 45–52); WHO for their collaboration; the translators who provided translation of all English materials to four additional languages; Marjorie Williamson, Valeria Sluzhevskaya, Guo Xiao Yuan, and Ilya Kalinin for their assistance with translation; Aleksandra Pokrovskaya and Nile Saunders for their help with preparation of participant information sheets; Mike Clarke for his work as an independent facilitator of the online interactive consensus meeting; Heather Barrington, Core Outcome Measures in Effectiveness Trials (COMET) Patient and Public Coordinator, for delivering the consensus pre-meeting for people with post-COVID-19 condition and their carers; the COMET People and Patient Participation, Involvement and Engagement working group; the COMET Management Group; and Sara Brookes for developing and sharing the slide set used in the pre-meeting. The views expressed in this publication are those of the authors and do not necessarily represent the views of the International Severe Acute Respiratory and Emerging Infection Consortium, the NIHR, or WHO. Publisher Copyright: © 2022 World Health Organization. Published by Elsevier Ltd. All rights reserved.

PY - 2022/7

Y1 - 2022/7

N2 - Health consequences that persist beyond the acute infection phase of COVID-19, termed post-COVID-19 condition (also commonly known as long COVID), vary widely and represent a growing global health challenge. Research on post-COVID-19 condition is expanding but, at present, no agreement exists on the health outcomes that should be measured in people living with the condition. To address this gap, we conducted an international consensus study, which included a comprehensive literature review and classification of outcomes for post-COVID-19 condition that informed a two-round online modified Delphi process followed by an online consensus meeting to finalise the core outcome set (COS). 1535 participants from 71 countries were involved, with 1148 individuals participating in both Delphi rounds. Eleven outcomes achieved consensus for inclusion in the final COS: fatigue; pain; post-exertion symptoms; work or occupational and study changes; survival; and functioning, symptoms, and conditions for each of cardiovascular, respiratory, nervous system, cognitive, mental health, and physical outcomes. Recovery was included a priori because it was a relevant outcome that was part of a previously published COS on COVID-19. The next step in this COS development exercise will be to establish the instruments that are most appropriate to measure these core outcomes. This international consensus-based COS should provide a framework for standardised assessment of adults with post-COVID-19 condition, aimed at facilitating clinical care and research worldwide.

AB - Health consequences that persist beyond the acute infection phase of COVID-19, termed post-COVID-19 condition (also commonly known as long COVID), vary widely and represent a growing global health challenge. Research on post-COVID-19 condition is expanding but, at present, no agreement exists on the health outcomes that should be measured in people living with the condition. To address this gap, we conducted an international consensus study, which included a comprehensive literature review and classification of outcomes for post-COVID-19 condition that informed a two-round online modified Delphi process followed by an online consensus meeting to finalise the core outcome set (COS). 1535 participants from 71 countries were involved, with 1148 individuals participating in both Delphi rounds. Eleven outcomes achieved consensus for inclusion in the final COS: fatigue; pain; post-exertion symptoms; work or occupational and study changes; survival; and functioning, symptoms, and conditions for each of cardiovascular, respiratory, nervous system, cognitive, mental health, and physical outcomes. Recovery was included a priori because it was a relevant outcome that was part of a previously published COS on COVID-19. The next step in this COS development exercise will be to establish the instruments that are most appropriate to measure these core outcomes. This international consensus-based COS should provide a framework for standardised assessment of adults with post-COVID-19 condition, aimed at facilitating clinical care and research worldwide.

UR - http://www.scopus.com/inward/record.url?scp=85132508166&partnerID=8YFLogxK

U2 - 10.1016/S2213-2600(22)00169-2

DO - 10.1016/S2213-2600(22)00169-2

M3 - Review article

C2 - 35714658

AN - SCOPUS:85132508166

SN - 2213-2600

VL - 10

SP - 715

EP - 724

JO - The Lancet Respiratory Medicine

JF - The Lancet Respiratory Medicine

IS - 7

ER -

A core outcome set for post-COVID-19 condition in adults for use in clinical practice and research: an international Delphi consensus study

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