Core Outcome Set for Research and Clinical Practice in Post COVID-19 Condition (Long COVID): ... ‘PC-COS’, 2022, Munblit et al

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

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.

Pre-print, https://papers.ssrn.com/sol3/papers.cfm?abstract_id=4017375

 

New definitions for long COVID developed with patients and carers

"Deciding on the key health outcomes in long COVID

The PC-COS researchers worked with more than 1,000 clinicians, researchers, patients and carers in 71 countries to develop a core outcome set for long COVID in adults. A core outcome set is an agreed-upon minimum set of outcomes that should be measured and reported in all studies in a specific field.

The core outcomes for long COVID in adults, available as a pre-print, are:

• fatigue or exhaustion
• pain
• post-exertion symptoms
• work/occupational and study changes
• survival
• ‘functioning, symptoms and conditions’ for each of the following outcomes:
  • cardiovascular
  • respiratory
  • nervous system
  • cognition
  • mental
  • physical

A ‘recovery’ outcome was added from a previously published core outcome set on COVID-19.

Dr Daniel Munblit, Honorary Senior Lecturer at Imperial College London and Professor at Sechenov University, Russia, said: “These core outcomes are the necessary minimum outcomes that should be measured in studies, to help standardise and harmonise data collection and research worldwide. However, this does not mean that other outcomes are not important.”

Dr Timothy Nicholson, Clinical Senior Lecturer at King's College London, added: “Long COVID is a new disease in terms of the heterogeneity and complexity of what we’re seeing, with multiple symptoms across many domains, so it’s a really complicated condition medically to grapple with.

“If everyone is measuring different things, it’s very hard to collate that information and compare it. What we’re doing with these core outcomes is creating one of the planks that allows building of the evidence base to inform our understanding of long COVID.”"

https://www.nihr.ac.uk/news/new-definitions-for-long-covid-developed-with-patients-and-carers/29865

 

Says more about the authors than anything else. It's certainly true that hurricane X is different from hurricane Y, does not excuse the whole "we should not be preparing for hurricane Y because, uh, reasons".

 

Does anyone know the authors of this study. The article is high level and refers to supplementary material for the details but that material doesn't appear to be available. Trying to anticipate whether this will be useful or not.

Edited to add the authors:
Daniel Munblit1,2,3, Timothy Nicholson4, , Athena Akrami5,6, Christian Apfelbacher7 , Jessica Chen8 , 5 Wouter De Groote9 , Janet V. Diaz9 , Sarah L. Gorst10, Nicola Harman11, Alisa Kokorina12, Piero Olliaro13 , 6 Callum Parr8 , Jacobus Preller14, Nicoline Schiess15, Jochen Schmitt16, Nina Seylanova17, Frances 7 Simpson18, Allison Tong19, Dale M. Needham 20,21,22,*, Paula R. Williamson11,

1 Department of Paediatrics and Paediatric Infectious Diseases, Institute of Child’s Health, Sechenov First Moscow State Medical University (Sechenov University), Moscow, Russia
2 Inflammation, Repair and Development Section, National Heart and Lung Institute, Faculty of Medicine, Imperial College London, London, United Kingdom
3 Research and Clinical Center for Neuropsychiatry, Moscow, Russia
4 Institute of Psychiatry, Psychology and Neuroscience, King's College London, UK
5 Sainsbury Wellcome Centre, UCL, London, UK
6 Patient-Led Research Collaborative
7 Institute of Social Medicine and Health Systems Research, Faculty of Medicine, Otto von Guericke University Magdeburg, Magdeburg, Germany
8 Faculty of Medicine, Imperial College London
9 WHO, NCD Department, Rehabilitation Programme, Geneva, Switzerland
10 Department of Health Data Science, University of Liverpool, UK
11 MRC/NIHR Trials Methodology Research Partnership, Department of Health Data Science, University of Liverpool (a member of Liverpool Health Partners), Liverpool, UK
12 Pirogov Russian National Research Medical University, Moscow, Russia
13 ISARIC Global Support Centre, Nuffield Department of Medicine, University of Oxford, Oxford, UK
14 Health Care Readiness Unit, Health Emergencies Unit, WHO
15 WHO Brain Health Unit, Geneva, Switzerland
16 Center for Evidence-based Healthcare, Medical Faculty Carl Gustav Carus, TU Dresden, Dresden, Germany
17 Sechenov Biomedical Science and Technology Park, Sechenov First Moscow State Medical University (Sechenov University), Moscow, Russia
18 Coventry University, Coventry, UK
19 Sydney School of Public Health, The University of Sydney
20 Outcomes After Critical Illness and Surgery (OACIS) Research Group, Johns Hopkins University, Baltimore MD
21 Pulmonary and Critical Care Medicine, Department of Medicine, Johns Hopkins University School of Medicine, Baltimore MD
22 Physical Medicine and Rehabilitation, Johns Hopkins University School of Medicine, Baltimore

 

Merged thread

Key outcomes of Long COVID identified in international consensus study

As Wessely is at Kings isn't this a bit disturbing that the co-lead author is from there.

ETA: The co-author is from the Institute of Psychiatry, Psychology and Neuroscience, King's College London, UK which may be different from the Institute of Psychiatry which is Wessely's institute

https://www.kcl.ac.uk/news/key-outcomes-of-long-covid-identified-in-international-consensus-study

 

The outcomes seem sensible to me.

 

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

Summary

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.

Open access, https://www.thelancet.com/journals/lanres/article/PIIS2213-2600(22)00169-2/fulltext#