Core outcome measurement set for research and clinical practice in post-COVID-19 condition (long COVID) in children and young people: an international Delphi consensus study "PC-COS Children"

Nina Seylanova; Anastasia Chernyavskaya; Natalia Degtyareva; Aigun Mursalova; Ali Ajam; Lin Xiao; Khazhar Aktulaeva; Philipp Roshchin; Polina Bobkova; Olalekan Lee Aiyegbusi; Anbarasu Theodore Anbu; Christian Apfelbacher; Ali Akbar Asadi-Pooya; Liat Ashkenazi-Hoffnung; Caroline Brackel; Danilo Buonsenso; Wouter de Groote; Janet V. Diaz; Daniele Dona; Audrey Dunn Galvin; Jon Genuneit; Helen Goss; Sarah E. Hughes; Christina J. Jones; Krutika Kuppalli; Laura A. Malone; Sammie McFarland; Dale M. Needham; Nikita Nekliudov; Timothy R. Nicholson; Carlos R. Oliveira; Nicoline Schiess; Terry Y. Segal; Louise Sigfrid; Claire Thorne; Susanne Vijverberg; John O. Warner; Wilson Milton Were; Paula R. Williamson; PC-COS Children Study Group

doi:10.1183/13993003.01761-2023

Core outcome measurement set for research and clinical practice in post-COVID-19 condition (long COVID) in children and young people: an international Delphi consensus study "PC-COS Children"

Nina Seylanova
, Anastasia Chernyavskaya
, Natalia Degtyareva
, Aigun Mursalova
, Ali Ajam
, Lin Xiao
, Khazhar Aktulaeva
, Philipp Roshchin
, Polina Bobkova
, Olalekan Lee Aiyegbusi
, Anbarasu Theodore Anbu
, Christian Apfelbacher
, Ali Akbar Asadi-Pooya
, Liat Ashkenazi-Hoffnung
, Caroline Brackel
, Danilo Buonsenso
, Wouter de Groote
, Janet V. Diaz
, Daniele Dona
, Audrey Dunn Galvin

Jon Genuneit, Helen Goss, Sarah E. Hughes, Christina J. Jones, Krutika Kuppalli, Laura A. Malone, Sammie McFarland, Dale M. Needham, Nikita Nekliudov, Timothy R. Nicholson, Carlos R. Oliveira, Nicoline Schiess, Terry Y. Segal, Louise Sigfrid, Claire Thorne, Susanne Vijverberg, John O. Warner, Wilson Milton Were, Paula R. Williamson, PC-COS Children Study Group

Independent researcher
Sechenov First Moscow State Medical University
National Medical Research Center for Children’s Health
University of Birmingham
Alder Hey Children's NHS Foundation Trust
Otto von Guericke University Magdeburg
Shiraz University of Medical Sciences
Thomas Jefferson University
Schneider Childrens Medical Center Israel
University of Amsterdam
Department of Paediatrics, Tergooi Hospital, Blaricum, The Netherlands
Catholic University of the Sacred Heart
Fondazione Policlinico Universitario Agostino Gemelli IRCCS
World Health Organization
University of Padua
University College Cork
Leipzig University
University of Surrey
Kennedy Krieger Institute
Johns Hopkins University
University of Washington
King's College London
Yale University
Yale New Haven Health System
University College London Hospitals, London, UK
University of Oxford
University College London
Imperial College London
University of Liverpool
Moscow Research and Clinical Center for Neuropsychiatry

Research output: Contribution to journal › Article › Academic › peer-review

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Abstract

The coronavirus disease 2019 (COVID-19) pandemic substantially impacted different age groups, with children and young people not exempted. Many have experienced enduring health consequences. Presently, there is no consensus on the health outcomes to assess in children and young people with post-COVID-19 condition. Furthermore, it is unclear which measurement instruments are appropriate for use in research and clinical management of children and young people with post-COVID-19. To address these unmet needs, we conducted a consensus study, aiming to develop a core outcome set (COS) and an associated core outcome measurement set (COMS) for evaluating post-COVID-19 condition in children and young people. Our methodology comprised of two phases. In phase 1 (to create a COS), we performed an extensive literature review and categorisation of outcomes, and prioritised those outcomes in a two-round online modified Delphi process followed by a consensus meeting. In phase 2 (to create the COMS), we performed another modified Delphi consensus process to evaluate measurement instruments for previously defined core outcomes from phase 1, followed by an online consensus workshop to finalise recommendations regarding the most appropriate instruments for each core outcome. In phase 1, 214 participants from 37 countries participated, with 154 (72%) contributing to both Delphi rounds. The subsequent online consensus meeting resulted in a final COS which encompassed seven critical outcomes: fatigue; post-exertion symptoms; work/occupational and study changes; as well as functional changes, symptoms, and conditions relating to cardiovascular, neuro-cognitive, gastrointestinal and physical outcomes. In phase 2, 11 international experts were involved in a modified Delphi process, selecting measurement instruments for a subsequent online consensus workshop where 30 voting participants discussed and independently scored the selected instruments. As a result of this consensus process, four instruments met a priori consensus criteria for inclusion: PedsQL multidimensional fatigue scale for "fatigue"; PedsQL gastrointestinal symptom scales for "gastrointestinal"; PedsQL cognitive functioning scale for "neurocognitive" and EQ-5D for "physical functioning". Despite proposing outcome measurement instruments for the remaining three core outcomes ("cardiovascular", "post-exertional malaise", "work/occupational and study changes"), a consensus was not achieved. Our international, consensus-based initiative presents a robust framework for evaluating post-COVID-19 condition in children and young people in research and clinical practice via a rigorously defined COS and associated COMS. It will aid in the uniform measurement and reporting of relevant health outcomes worldwide.

Original language	English
Article number	2301761
Journal	The European respiratory journal
Volume	63
Issue number	3
DOIs	https://doi.org/10.1183/13993003.01761-2023
Publication status	Published - 1 Mar 2024

UN SDGs

This output contributes to the following UN Sustainable Development Goals (SDGs)

SDG 3 Good Health and Well-being

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Seylanova, N., Chernyavskaya, A., Degtyareva, N., Mursalova, A., Ajam, A., Xiao, L., Aktulaeva, K., Roshchin, P., Bobkova, P., Aiyegbusi, O. L., Anbu, A. T., Apfelbacher, C., Asadi-Pooya, A. A., Ashkenazi-Hoffnung, L., Brackel, C., Buonsenso, D., de Groote, W., Diaz, J. V., Dona, D., ... PC-COS Children Study Group (2024). Core outcome measurement set for research and clinical practice in post-COVID-19 condition (long COVID) in children and young people: an international Delphi consensus study "PC-COS Children". The European respiratory journal, 63(3), Article 2301761. https://doi.org/10.1183/13993003.01761-2023

@article{eb93e097d64a4d5291081d9533af726c,

title = "Core outcome measurement set for research and clinical practice in post-COVID-19 condition (long COVID) in children and young people: an international Delphi consensus study {"}PC-COS Children{"}",

abstract = "The coronavirus disease 2019 (COVID-19) pandemic substantially impacted different age groups, with children and young people not exempted. Many have experienced enduring health consequences. Presently, there is no consensus on the health outcomes to assess in children and young people with post-COVID-19 condition. Furthermore, it is unclear which measurement instruments are appropriate for use in research and clinical management of children and young people with post-COVID-19. To address these unmet needs, we conducted a consensus study, aiming to develop a core outcome set (COS) and an associated core outcome measurement set (COMS) for evaluating post-COVID-19 condition in children and young people. Our methodology comprised of two phases. In phase 1 (to create a COS), we performed an extensive literature review and categorisation of outcomes, and prioritised those outcomes in a two-round online modified Delphi process followed by a consensus meeting. In phase 2 (to create the COMS), we performed another modified Delphi consensus process to evaluate measurement instruments for previously defined core outcomes from phase 1, followed by an online consensus workshop to finalise recommendations regarding the most appropriate instruments for each core outcome. In phase 1, 214 participants from 37 countries participated, with 154 (72\%) contributing to both Delphi rounds. The subsequent online consensus meeting resulted in a final COS which encompassed seven critical outcomes: fatigue; post-exertion symptoms; work/occupational and study changes; as well as functional changes, symptoms, and conditions relating to cardiovascular, neuro-cognitive, gastrointestinal and physical outcomes. In phase 2, 11 international experts were involved in a modified Delphi process, selecting measurement instruments for a subsequent online consensus workshop where 30 voting participants discussed and independently scored the selected instruments. As a result of this consensus process, four instruments met a priori consensus criteria for inclusion: PedsQL multidimensional fatigue scale for {"}fatigue{"}; PedsQL gastrointestinal symptom scales for {"}gastrointestinal{"}; PedsQL cognitive functioning scale for {"}neurocognitive{"} and EQ-5D for {"}physical functioning{"}. Despite proposing outcome measurement instruments for the remaining three core outcomes ({"}cardiovascular{"}, {"}post-exertional malaise{"}, {"}work/occupational and study changes{"}), a consensus was not achieved. Our international, consensus-based initiative presents a robust framework for evaluating post-COVID-19 condition in children and young people in research and clinical practice via a rigorously defined COS and associated COMS. It will aid in the uniform measurement and reporting of relevant health outcomes worldwide.",

author = "Nina Seylanova and Anastasia Chernyavskaya and Natalia Degtyareva and Aigun Mursalova and Ali Ajam and Lin Xiao and Khazhar Aktulaeva and Philipp Roshchin and Polina Bobkova and Aiyegbusi, \{Olalekan Lee\} and Anbu, \{Anbarasu Theodore\} and Christian Apfelbacher and Asadi-Pooya, \{Ali Akbar\} and Liat Ashkenazi-Hoffnung and Caroline Brackel and Danilo Buonsenso and \{de Groote\}, Wouter and Diaz, \{Janet V.\} and Daniele Dona and \{Dunn Galvin\}, Audrey and Jon Genuneit and Helen Goss and Hughes, \{Sarah E.\} and Jones, \{Christina J.\} and Krutika Kuppalli and Malone, \{Laura A.\} and Sammie McFarland and Needham, \{Dale M.\} and Nikita Nekliudov and Nicholson, \{Timothy R.\} and Oliveira, \{Carlos R.\} and Nicoline Schiess and Segal, \{Terry Y.\} and Louise Sigfrid and Claire Thorne and Susanne Vijverberg and Warner, \{John O.\} and Were, \{Wilson Milton\} and Williamson, \{Paula R.\} and \{PC-COS Children Study Group\} and Daniel Munblit",

note = "Publisher Copyright: Copyright {\textcopyright}The authors 2024.",

year = "2024",

month = mar,

day = "1",

doi = "10.1183/13993003.01761-2023",

language = "English",

volume = "63",

journal = "The European respiratory journal",

issn = "0903-1936",

publisher = "European Respiratory Society",

number = "3",

}

Seylanova, N, Chernyavskaya, A, Degtyareva, N, Mursalova, A, Ajam, A, Xiao, L, Aktulaeva, K, Roshchin, P, Bobkova, P, Aiyegbusi, OL, Anbu, AT, Apfelbacher, C, Asadi-Pooya, AA, Ashkenazi-Hoffnung, L, Brackel, C, Buonsenso, D, de Groote, W, Diaz, JV, Dona, D, Dunn Galvin, A, Genuneit, J, Goss, H, Hughes, SE, Jones, CJ, Kuppalli, K, Malone, LA, McFarland, S, Needham, DM, Nekliudov, N, Nicholson, TR, Oliveira, CR, Schiess, N, Segal, TY, Sigfrid, L, Thorne, C, Vijverberg, S, Warner, JO, Were, WM, Williamson, PR & PC-COS Children Study Group 2024, 'Core outcome measurement set for research and clinical practice in post-COVID-19 condition (long COVID) in children and young people: an international Delphi consensus study "PC-COS Children"', The European respiratory journal, vol. 63, no. 3, 2301761. https://doi.org/10.1183/13993003.01761-2023

Core outcome measurement set for research and clinical practice in post-COVID-19 condition (long COVID) in children and young people: an international Delphi consensus study "PC-COS Children". / Seylanova, Nina; Chernyavskaya, Anastasia; Degtyareva, Natalia et al.
In: The European respiratory journal, Vol. 63, No. 3, 2301761, 01.03.2024.

Research output: Contribution to journal › Article › Academic › peer-review

TY - JOUR

T1 - Core outcome measurement set for research and clinical practice in post-COVID-19 condition (long COVID) in children and young people

T2 - an international Delphi consensus study "PC-COS Children"

AU - Seylanova, Nina

AU - Chernyavskaya, Anastasia

AU - Degtyareva, Natalia

AU - Mursalova, Aigun

AU - Ajam, Ali

AU - Xiao, Lin

AU - Aktulaeva, Khazhar

AU - Roshchin, Philipp

AU - Bobkova, Polina

AU - Aiyegbusi, Olalekan Lee

AU - Anbu, Anbarasu Theodore

AU - Apfelbacher, Christian

AU - Asadi-Pooya, Ali Akbar

AU - Ashkenazi-Hoffnung, Liat

AU - Brackel, Caroline

AU - Buonsenso, Danilo

AU - de Groote, Wouter

AU - Diaz, Janet V.

AU - Dona, Daniele

AU - Dunn Galvin, Audrey

AU - Genuneit, Jon

AU - Goss, Helen

AU - Hughes, Sarah E.

AU - Jones, Christina J.

AU - Kuppalli, Krutika

AU - Malone, Laura A.

AU - McFarland, Sammie

AU - Needham, Dale M.

AU - Nekliudov, Nikita

AU - Nicholson, Timothy R.

AU - Oliveira, Carlos R.

AU - Schiess, Nicoline

AU - Segal, Terry Y.

AU - Sigfrid, Louise

AU - Thorne, Claire

AU - Vijverberg, Susanne

AU - Warner, John O.

AU - Were, Wilson Milton

AU - Williamson, Paula R.

AU - PC-COS Children Study Group

AU - Munblit, Daniel

PY - 2024/3/1

Y1 - 2024/3/1

N2 - The coronavirus disease 2019 (COVID-19) pandemic substantially impacted different age groups, with children and young people not exempted. Many have experienced enduring health consequences. Presently, there is no consensus on the health outcomes to assess in children and young people with post-COVID-19 condition. Furthermore, it is unclear which measurement instruments are appropriate for use in research and clinical management of children and young people with post-COVID-19. To address these unmet needs, we conducted a consensus study, aiming to develop a core outcome set (COS) and an associated core outcome measurement set (COMS) for evaluating post-COVID-19 condition in children and young people. Our methodology comprised of two phases. In phase 1 (to create a COS), we performed an extensive literature review and categorisation of outcomes, and prioritised those outcomes in a two-round online modified Delphi process followed by a consensus meeting. In phase 2 (to create the COMS), we performed another modified Delphi consensus process to evaluate measurement instruments for previously defined core outcomes from phase 1, followed by an online consensus workshop to finalise recommendations regarding the most appropriate instruments for each core outcome. In phase 1, 214 participants from 37 countries participated, with 154 (72%) contributing to both Delphi rounds. The subsequent online consensus meeting resulted in a final COS which encompassed seven critical outcomes: fatigue; post-exertion symptoms; work/occupational and study changes; as well as functional changes, symptoms, and conditions relating to cardiovascular, neuro-cognitive, gastrointestinal and physical outcomes. In phase 2, 11 international experts were involved in a modified Delphi process, selecting measurement instruments for a subsequent online consensus workshop where 30 voting participants discussed and independently scored the selected instruments. As a result of this consensus process, four instruments met a priori consensus criteria for inclusion: PedsQL multidimensional fatigue scale for "fatigue"; PedsQL gastrointestinal symptom scales for "gastrointestinal"; PedsQL cognitive functioning scale for "neurocognitive" and EQ-5D for "physical functioning". Despite proposing outcome measurement instruments for the remaining three core outcomes ("cardiovascular", "post-exertional malaise", "work/occupational and study changes"), a consensus was not achieved. Our international, consensus-based initiative presents a robust framework for evaluating post-COVID-19 condition in children and young people in research and clinical practice via a rigorously defined COS and associated COMS. It will aid in the uniform measurement and reporting of relevant health outcomes worldwide.

AB - The coronavirus disease 2019 (COVID-19) pandemic substantially impacted different age groups, with children and young people not exempted. Many have experienced enduring health consequences. Presently, there is no consensus on the health outcomes to assess in children and young people with post-COVID-19 condition. Furthermore, it is unclear which measurement instruments are appropriate for use in research and clinical management of children and young people with post-COVID-19. To address these unmet needs, we conducted a consensus study, aiming to develop a core outcome set (COS) and an associated core outcome measurement set (COMS) for evaluating post-COVID-19 condition in children and young people. Our methodology comprised of two phases. In phase 1 (to create a COS), we performed an extensive literature review and categorisation of outcomes, and prioritised those outcomes in a two-round online modified Delphi process followed by a consensus meeting. In phase 2 (to create the COMS), we performed another modified Delphi consensus process to evaluate measurement instruments for previously defined core outcomes from phase 1, followed by an online consensus workshop to finalise recommendations regarding the most appropriate instruments for each core outcome. In phase 1, 214 participants from 37 countries participated, with 154 (72%) contributing to both Delphi rounds. The subsequent online consensus meeting resulted in a final COS which encompassed seven critical outcomes: fatigue; post-exertion symptoms; work/occupational and study changes; as well as functional changes, symptoms, and conditions relating to cardiovascular, neuro-cognitive, gastrointestinal and physical outcomes. In phase 2, 11 international experts were involved in a modified Delphi process, selecting measurement instruments for a subsequent online consensus workshop where 30 voting participants discussed and independently scored the selected instruments. As a result of this consensus process, four instruments met a priori consensus criteria for inclusion: PedsQL multidimensional fatigue scale for "fatigue"; PedsQL gastrointestinal symptom scales for "gastrointestinal"; PedsQL cognitive functioning scale for "neurocognitive" and EQ-5D for "physical functioning". Despite proposing outcome measurement instruments for the remaining three core outcomes ("cardiovascular", "post-exertional malaise", "work/occupational and study changes"), a consensus was not achieved. Our international, consensus-based initiative presents a robust framework for evaluating post-COVID-19 condition in children and young people in research and clinical practice via a rigorously defined COS and associated COMS. It will aid in the uniform measurement and reporting of relevant health outcomes worldwide.

UR - https://www.scopus.com/pages/publications/85183355776

U2 - 10.1183/13993003.01761-2023

DO - 10.1183/13993003.01761-2023

M3 - Article

C2 - 38359962

SN - 0903-1936

VL - 63

JO - The European respiratory journal

JF - The European respiratory journal

IS - 3

M1 - 2301761

ER -

Core outcome measurement set for research and clinical practice in post-COVID-19 condition (long COVID) in children and young people: an international Delphi consensus study "PC-COS Children"

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