TY - JOUR
T1 - Core outcome measurement instruments for use in clinical and research settings for adults with post-COVID-19 condition
T2 - an international Delphi consensus study
AU - Gorst, Sarah L.
AU - Seylanova, Nina
AU - Dodd, Susanna R.
AU - Harman, Nicola L.
AU - O'Hara, Margaret
AU - Terwee, Caroline B.
AU - Williamson, Paula R.
AU - Needham, Dale M.
AU - Munblit, Daniel
AU - Nicholson, Timothy R.
AU - PC-COS study group
AU - Aiyegbusi, Olalekan L.
AU - Akrami, Athena
AU - Apfelbacher, Christian
AU - Calvert, Melanie
AU - Chen, Jessica
AU - Chernyawskaya, Anastasia
AU - Fallon, Vicky
AU - Haroon, Shamil
AU - Hughes, Sarah E.
AU - Jaure, Allison
AU - Kokorinia, Alisa
AU - Michelen, Melina
AU - Olliaro, Piero
AU - Parr, Callum
AU - Pokrovskaya, Alexandra
AU - Saunders, Nile
AU - Schmitt, Jochen
AU - Shemilt, Ian
AU - Sigfrid, Louise
AU - Simpson, Frances
AU - Sivan, Manoj
AU - Stavropoulous, Charitini
N1 - Funding Information: This study was funded by the UK's National Institute for Health and Care Research (NIHR; grant COV-LT2-0072). The funder had no role in the study design, data collection and analysis, decision to publish, or preparation of the manuscript. TRN and PRW have received funding from the NIHR. DM has received grants from the British Embassy in Moscow, the NIHR, and the Russian Foundation for Basic Research. NLH has received grants from Lyme Disease Action and the Foundation for Sarcoidosis Research. We thank all participants of the consensus development process, and particularly the people with lived experience of post-COVID-19 condition and their carers; Wouter De Groote, Janet Diaz, Krutika Kuppalli, John Marshall, Srinivas Murthy, Jakobus Preller, and Nicoline Schiess of WHO and the WHO COVID-19 Clinical Research working group for their technical input and support in coordination and dissemination of the survey; Mike Clarke for his work as an independent facilitator of the online interactive consensus meeting; and Christina Barratt, Sophie Evans, Lesley MacNiven, Natalie Rogers, and Kirsty Stanley, members of Long Covid Support, for providing critical input into the design of the instrument cards. 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: This study was funded by the UK's National Institute for Health and Care Research (NIHR; grant COV-LT2-0072). The funder had no role in the study design, data collection and analysis, decision to publish, or preparation of the manuscript. TRN and PRW have received funding from the NIHR. DM has received grants from the British Embassy in Moscow, the NIHR, and the Russian Foundation for Basic Research. NLH has received grants from Lyme Disease Action and the Foundation for Sarcoidosis Research. We thank all participants of the consensus development process, and particularly the people with lived experience of post-COVID-19 condition and their carers; Wouter De Groote, Janet Diaz, Krutika Kuppalli, John Marshall, Srinivas Murthy, Jakobus Preller, and Nicoline Schiess of WHO and the WHO COVID-19 Clinical Research working group for their technical input and support in coordination and dissemination of the survey; Mike Clarke for his work as an independent facilitator of the online interactive consensus meeting; and Christina Barratt, Sophie Evans, Lesley MacNiven, Natalie Rogers, and Kirsty Stanley, members of Long Covid Support, for providing critical input into the design of the instrument cards. 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: © 2023 Elsevier Ltd
PY - 2023
Y1 - 2023
N2 - Post-COVID-19 condition (also known as long COVID) is a new, complex, and poorly understood disorder. A core outcome set (COS) for post-COVID-19 condition in adults has been developed and agreement is now required on the most appropriate measurement instruments for these core outcomes. We conducted an international consensus study involving multidisciplinary experts and people with lived experience of long COVID. The study comprised a literature review to identify measurement instruments for the core outcomes, a three-round online modified Delphi process, and an online consensus meeting to generate a core outcome measurement set (COMS). 594 individuals from 58 countries participated. The number of potential instruments for the 12 core outcomes was reduced from 319 to 19. Consensus was reached for inclusion of the modified Medical Research Council Dyspnoea Scale for respiratory outcomes. Measures for two relevant outcomes from a previously published COS for acute COVID-19 were also included: time until death, for survival, and the Recovery Scale for COVID-19, for recovery. Instruments were suggested for consideration for the remaining nine core outcomes: fatigue or exhaustion, pain, post-exertion symptoms, work or occupational and study changes, and cardiovascular, nervous system, cognitive, mental health, and physical outcomes; however, consensus was not achieved for instruments for these outcomes. The recommended COMS and instruments for consideration provide a foundation for the evaluation of post-COVID-19 condition in adults, which should help to optimise clinical care and accelerate research worldwide. Further assessment of this COMS is warranted as new data emerge on existing and novel measurement instruments.
AB - Post-COVID-19 condition (also known as long COVID) is a new, complex, and poorly understood disorder. A core outcome set (COS) for post-COVID-19 condition in adults has been developed and agreement is now required on the most appropriate measurement instruments for these core outcomes. We conducted an international consensus study involving multidisciplinary experts and people with lived experience of long COVID. The study comprised a literature review to identify measurement instruments for the core outcomes, a three-round online modified Delphi process, and an online consensus meeting to generate a core outcome measurement set (COMS). 594 individuals from 58 countries participated. The number of potential instruments for the 12 core outcomes was reduced from 319 to 19. Consensus was reached for inclusion of the modified Medical Research Council Dyspnoea Scale for respiratory outcomes. Measures for two relevant outcomes from a previously published COS for acute COVID-19 were also included: time until death, for survival, and the Recovery Scale for COVID-19, for recovery. Instruments were suggested for consideration for the remaining nine core outcomes: fatigue or exhaustion, pain, post-exertion symptoms, work or occupational and study changes, and cardiovascular, nervous system, cognitive, mental health, and physical outcomes; however, consensus was not achieved for instruments for these outcomes. The recommended COMS and instruments for consideration provide a foundation for the evaluation of post-COVID-19 condition in adults, which should help to optimise clinical care and accelerate research worldwide. Further assessment of this COMS is warranted as new data emerge on existing and novel measurement instruments.
UR - http://www.scopus.com/inward/record.url?scp=85176212590&partnerID=8YFLogxK
U2 - https://doi.org/10.1016/S2213-2600(23)00370-3
DO - https://doi.org/10.1016/S2213-2600(23)00370-3
M3 - Review article
C2 - 37926103
SN - 2213-2600
JO - The Lancet Respiratory Medicine
JF - The Lancet Respiratory Medicine
ER -