Core Outcome Measures for Post-Covid condition/Long Covid

The emergence of severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) has placed a significant burden on public health worldwide. As of end of March 2021, there have been an estimated 125 million cases of coronavirus disease 2019 (COVID-19) globally. The acute presentation of COVID-19 has now been widely investigated and risk factors for in-hospital mortality identified.

It has now become evident that a significant portion of those with COVID-19 subsequently experience lasting symptoms including fatigue, breathlessness and neurological complaints months after the acute infection. This is now commonly referred to as Long COVID but has also been described as post-COVID syndrome or COVID long-haulers. Recently published the UK National Institute for Health and Clinical Excellence (NICE) COVID-19 guideline call infection sequalae “Post-COVID-19 syndrome”, defining it as “signs and symptoms that develop during or after an infection consistent with COVID-19, continue for more than 12 weeks and are not explained by an alternative diagnosis”. Interim definitions for the COVID-19 sequelae are, however, based on limited evidence from small cohorts with short-term follow-up. The World Health Organization at a recent global forum called countries to prioritise rehabilitation for the consequences of COVID-19, collect harmonised information on Long Covid and proposed the term “Post-Covid condition”.

There is an urgent need to optimise and standardise outcome measures for this important and emerging patient group both for clinical services and for research, especially clinical trials, to allow comparing and pooling of data. The aim of this project is to rapidly define a core outcome set (COS) for Post-Covid condition/Long Covid for both clinical (from low to high resource settings) and research use.

Contributors

Daniel Munblit, Sechenov University, Moscow, Russia/ Imperial College London, London, UK
Timothy Nicholson, King's College London, London, UK
Paula Williamson, University of Liverpool, UK
Christian Apfelbacher, University of Magdeburg, Germany
Piero Olliaro, ISARIC, University of Oxford, UK
Theo Vos, University of Washington, Seattle, USA
Margaret Herridge, University of Toronto, Canada
Dale Needham, Johns Hopkins University, USA
John Marshall, University of Toronto, Canada
Louise Sigfrid, ISARIC, University of Oxford, UK
Jochen Schmitt, University Dresden, Germany
Frances Simpson, University of Coventry, UK
Calum Semple, University of Liverpool, UK
John O Warner, Imperial College London, London, UK
Allison Tong, The University of Sydney, Australia
Janet Scott, University of Glasgow, UK
Jon Genuneit, University of Leipzig, Germany
Nina Seylanova, Sechenov University, Moscow, Russia
Alla Guekht, Research and Clinical Center for Neuropsychiatry, Moscow, Russia
Audrey DunnGalvin, University of Cork, Ireland
Wouter De Groot, World Health Organization

Further Study Information

Current Stage: Ongoing
Date: March 2021 - March 2022
Funding source(s): No external funding


Health Area

Disease Category: Infectious disease

Disease Name: Coronavirus, Post-Covid condition

Target Population

Age Range: 0 - 120

Sex: Either

Nature of Intervention: Any

Stakeholders Involved

- Clinical experts
- Consumers (caregivers)
- Consumers (patients)
- Families
- Governmental agencies
- Journal editors
- Methodologists
- Patient/ support group representatives
- Researchers
- Service providers
- Service users
- Statisticians
- Epidemiologists

Study Type

- COS for clinical trials or clinical research
- COS for practice
- Recommendations for outcome measures (measurement/how)

Method(s)

- Consensus meeting
- Delphi process
- Focus group(s)
- Literature review
- Semi structured discussion
- Survey
- Systematic review

- Development of a long list of outcomes based on the data from ongoing ISARIC Long Covid living systematic review.

- Develop a survey for further translation into multiple languages which will be subsequently delivered in a single round to all relevant stakeholders.

- Separate surveys for (a) adults and (b) parents/carers and children are planned.

- Tiers of COS may be considered (e.g. Tier 1 – general and Tier 2 subspecialised to assess system-specific consequences of COVID-19).

- Existing COS initiatives will be reviewed for potential applicability for use in post-covid condition.

- Consensus meeting.