Core outcome set developers’ response to COVID-19 (April 2021)

Background

Many clinical trials and systematic reviews are already underway, or will begin shortly, to strengthen the evidence base for the COVID-19 response. Core outcome sets (COS), showing the outcomes that should be measured and reported in these studies, will ensure that this evidence base will contain, as a minimum, the key information needed by decision makers about the effects of interventions. This briefing paper has been prepared and is maintained by COMET to summarise work to date on COS for COVID-19. The COMET team will try to respond to any queries you have about it. COMET will also facilitate contact with COS developers to help determine which COS may be most relevant to your particular research study. A summary of all of this work is available in the COMET database - http://www.comet-initiative.org/Studies/Details/1538 - and will be updated as further evidence becomes available.

(1) COS for studies for the prevention of COVID-19 transmission

A ‘core’ COS has recently been developed for studies evaluating public health, primary and secondary care interventions to prevent COVID-19, identifying SARS-CoV-2 infection and intervention-specific harms as critical outcomes to measure in all COVID-19 prevention studies [i]. This work is being used to inform the development of supplementary specific ‘modules’ that may be required for key areas of relevance. One such ‘module’ is the prevention of COVID-19 transmission in care homes [ii].

[i] Core COS for prevention – http://www.comet-initiative.org/Studies/Details/1594
Lead(s): Paula R Williamson, University of Liverpool, UK; Jane Blazeby, University of Bristol, UK
Summary: This ‘core’ COS was published as a short report in the Cochrane COVID-19 Supplement (pages 15-18) - https://www.cochranelibrary.com/cdsr/doi/10.1002/14651858.CD202002/full
Work is now underway to examine how SARS-CoV-2 infection is measured in different settings.

[ii] COS for prevention in care homes – http://www.comet-initiative.org/Studies/Details/1810
Lead: Kerry Hood, Cardiff University, UK
Summary: The aim of this study is to build on the ‘core’ COS that includes a minimum set of outcomes relevant to all studies of COVID-19 disease prevention [i] and to develop a supplementary specific module for COVID-19 prevention in care homes.

(2) COS for studies for the treatment of patients with confirmed or suspected COVID-19

[i] Post-COVID condition/Long COVID – http://www.comet-initiative.org/Studies/Details/1847
Lead: Daniel Munblit, Sechenov University, Russia/ Imperial College London, UK
Summary: The aim of this project is to rapidly define a COS for Post-COVID condition/Long COVID for both clinical (from low to high resource settings) and research use.


[ii] COS for studies of any intervention in hospitalised patients with confirmed or suspected COVID-19

Table 1 shows a ‘meta-COS’ resulting from four COS projects conducted in parallel, and agreed by the leads of the projects.

History: In February 2020, three COVID-19 COS projects were registered in the COMET database (a)-(c). A fourth was registered in March (d), with the aim of engaging patients in the COS development process, and is therefore complementary to the existing initiatives. Each COS is slightly different in its scope or methods, including the range of stakeholders involved, and they are complementary to one another.

Earlier work by ISARIC sought to standardize outcome data collected by research networks conducting clinical and epidemiological research in preparation for and during epidemics and pandemics (e). In addition, existing COS projects for specific interventions used in and after critical care may be relevant (f)-(i).

Teleconferences were convened with representatives of the four COVID-19 COS for studies of in hospital patients (Junhua Zhang, John Marshall, Ruijin Qiu, Allison Tong) and the COMET Initiative (Paula Williamson, Liz Gargon, Mike Clarke). These discussions will continue, in order to maintain awareness of work on this topic, determine what information to disseminate more widely, and promote the uptake of COS in relevant research.

The three completed COS [a-c] overlapped, and a ‘meta-COS’ for research in adult hospitalised patients (Table 1) was agreed by the leads of the COS development projects [a-c] during a teleconference on 2nd April 2020. The results of the fourth COS [d] also agreed with the meta-COS, and Table 1 has been updated accordingly.

Adverse events: Adverse events, relevant to the particular research question, should also be measured and reported.

Paediatric studies: During the COVID-19 pandemic, children have generally presented with mild disease. The rates of clinical infection, hospitalisation, need for respiratory support, and mortality, are low. Current and future clinical trials are focussed on adults with COVID-19 who are acutely or critically ill, and hospitalised or on intensive care. From a paediatric perspective it is reasonable to utilise the adult meta-COS for COVID-19 in studies of children, or those in which children are included with adults. As clinical trials are developed to evaluate vaccines and prophylactic medications, the studies may be more focussed on children and relevant efficacy and safety outcomes for this age group may need to be reconsidered.

Each of the COS (a)-(d) include other core outcome domains for hospitalised patients, and also core outcome domains for those patients with asymptomatic or mild disease who are not hospitalised. These other outcomes deemed core but not in all COS are described in Table 2.

(a) http://www.comet-initiative.org/Studies/Details/1528
Lead: John Marshall, University of Toronto, Canada on behalf of the WHO Working Group on the Clinical Characteristics of COVID-19 infection
Summary: WHO has published a master protocol for COVID-19 studies, which recommends the outcomes to be measured in each of these. The WHO Working Group undertook a consensus exercise to agree a COS and the report is now published: https://doi.org/10.1016/S1473-3099(20)30483-7

(b) http://www.comet-initiative.org/Studies/Details/1523
Lead: Junhua Zhang, Evidence-Based Medicine Center, Tianjin University of Traditional Chinese Medicine, Tianjin, China
Summary: This COS is published - https://www.sciencedirect.com/science/article/pii/S2095809920300424?via%3Dihub
A Case Report Form for this COS has been drafted. Please contact Janneke van’t Hooft, janneke@stanford.edu, to obtain a copy.

(c) http://www.comet-initiative.org/Studies/Details/1507
Lead: Ruijin Qiu, Dongzhimen Hospital, Beijing University of Chinese Medicine, China
Summary: The COS is published: https://www.frontiersin.org/articles/10.3389/fphar.2020.00781/full.

(d) http://www.comet-initiative.org/Studies/Details/1548
Lead: Allison Tong, University of Sydney, Australia
Summary: This COS is now published: https://journals.lww.com/ccmjournal/Fulltext/2020/11000/Core_Outcomes_Set_for_Trials_in_People_With.10.aspx.
The study has a particular focus on patients, family and community members. You can visit the website for more information about this study: https://www.covid-19-cos.org.

(e) http://www.comet-initiative.org/Studies/Details/617
Lead: Calum Semple, University of Liverpool, UK on behalf of ISARIC
Summary: This work was done in 2014 with the aim to change how research is carried out during and between epidemics. Results of the work completed are available via the link. It informed the development of the WHO-ISARIC COVID-19 Clinical Platform (CCP) study case report form, which is available from Calum Semple, M.G.Semple@liverpool.ac.uk, prior to its publication on the WHO website.


Intervention-specific COS that may also be relevant for research in hospitalised patients with confirmed or suspected COVID-19

(f) http://www.comet-initiative.org/Studies/Details/292
Lead: Bronagh Blackwood, Queen's University Belfast, UK
Summary: This is a COS for trials of interventions intended to modify the duration of ventilation for patients being treated in an Intensive Care Unit.

(g) http://www.comet-initiative.org/Studies/Details/288
Lead: Bronwen Connolly, Queen's University Belfast, UK
Summary: This is an ongoing COS for trials of physical rehabilitation in critically ill patients, within intensive care units (ICU) and following their discharge from ICU and hospital. Please contact Bronwen Connolly for more information and preliminary results, bronwen.connolly@nhs.net.

[iii] COS that may be relevant for studies of any intervention post-discharge

Any intervention

(h) http://www.comet-initiative.org/Studies/Details/1019
Lead: Dale Needham, Johns Hopkins University, US
Summary: This is a published COS for all clinical research studies evaluating acute respiratory failure survivors after hospital discharge. This COS is appropriate for both observational and intervention studies that want to evaluate post-discharge outcomes.

Intervention-specific COS that may also be relevant for post-discharge studies

(g) http://www.comet-initiative.org/Studies/Details/288
Lead: Bronwen Connolly, Queen's University Belfast, UK
Summary: This is an ongoing COS for trials of physical rehabilitation in critically ill patients, within intensive care units (ICU) and following their discharge from ICU and hospital.

(i) http://www.comet-initiative.org/Studies/Details/786
Lead: M Major, European School of Physiotherapy, Amsterdam University of Applied Sciences, Amsterdam, The Netherlands
Summary: This is a COS for trials of physical therapy in the post-hospital rehabilitation of people who have survived critical illness.

[iv] COS for studies of any intervention in patients with confirmed or suspected COVID-19 in all settings (excluding prevention and post-recovery)

(d) http://www.comet-initiative.org/Studies/Details/1548
Lead: Allison Tong, University of Sydney, Australia
Summary: This COS is now published: https://journals.lww.com/ccmjournal/Fulltext/2020/11000/Core_Outcomes_Set_for_Trials_in_People_With.10.aspx.
The study has a particular focus on patients, family and community members. You can visit the website for more information about this study: https://www.covid-19-cos.org.


To download this summary as a PDF, click here.

Keyword: Coronavirus

Contributors

Paula Williamson (University of Liverpool)
Liz Gargon (University of Liverpool)
Mike Clarke (Queen's University Belfast)
John Marshall (WHO)
Junhua Zhang (Tianjin University of Traditional Chinese Medicine)
Ruijin Qiu (Beijing University of Chinese Medicine)
Bronagh Blackwood (Queen’s University Belfast)
Ian Sinha (Alder Hey Children’s Hospital)
Calum Semple (Alder Hey Children’s Hospital)
Allison Tong (University of Sydney)
Kerry Hood (Cardiff University)
Daniel Munblit (Sechenov University/Imperial College London)

Further Study Information

Current Stage: Ongoing
Date: March 2020 - March 2022
Funding source(s): None

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Method(s)

Linked Studies

• Identifying common outcome measures for epidemic and pandemic studies of severe acute respiratory infection
• Core Outcome Set for Clinical Trials of COVID-19 Based on Traditional Chinese and Western Medicine
• Core Outcome Set for Clinical Trials on Coronavirus Disease 2019 (COS-COVID)
• A minimal common outcome measure set for COVID-19 clinical research
• Core Outcomes Set for Trials in People With Coronavirus Disease 2019

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