A Core Outcome Set for studies evaluating public health, primary and secondary care interventions for prevention of COVID-19 transmission – the COS-COVID-P study

COVID-19 has significant morbidity and mortality. Disease spread occurs in several ways, respiratory transmission, bodily fluid contamination etc. Reduction of spread is essential to reduce morbidity and mortality of COVID. Methods to minimise spread have been implemented worldwide including:
(i) Public health measures (e.g. vaccines, lockdown, closing schools, social distancing, hand washing)
(ii) Primary & secondary care practice (e.g. PPE, increased time for appointments/interventions)
Whilst studies focus on mitigation of disease spread they include other issues relevant to the population of interest and type of intervention (e.g. educational outcomes in school studies, user acceptability of PPE in secondary care). Evidence is accumulating to describe effectiveness of interventions, however, there are challenges with evidence synthesis due to inconsistent selection, measurement and reporting of outcomes (Chu et al, Lancet 2020; https://www.cochranelibrary.com/covid-19). This leads to research waste and inefficiency, slowing worldwide implementation of methods to prevent disease spread. A solution to this issue is to develop a COS for studies of interventions to prevent COVID-19 infection. This approach may require development of a ‘core’ COS with the addition of specific COS (‘modules’) to tackle key areas of relevance, or a single COS may be sufficient.

Aim

We propose to develop a core COS which will include a minimum set of outcomes relevant to all studies of COVID-19 disease prevention and to undertake work to inform the development of supplementary specific modules.

Contributors

Professor Jane Blazeby, University of Bristol, UK
Professor Paula Williamson, University of Liverpool, UK

Steering Committee being established:
Mike Clarke, COMET
Sean Tunis, COMET
John Ioannidis, COVID-Evidence
Lars Hemkens, COVID-Evidence
Allison Tong, Australian COS-COVID group
Jonathan Craig, Australian COS-COVID group
Junhua Zhang, Chinese COS-COVID group
Liang Du, Chinese COS-COVID group
Ella Flemyng, Cochrane, UK
Elie Akl, American University of Beirut
Calum Semple, ISARIC
Debbi Caldwell, University of Bristol
Atle Fretheim, Norwegian Institute of Public Health
Claire Goodman, University of Hertfordshire
David Lalloo, UK NIHR COVID Prevention Strategy Group
Adam Finn, European Technical Advisory Group of Experts on Immunization
Martin Knapp, London School of Economics and Political Science
Aneel Bhangu, University of Birmingham
Richard Morley, Cochrane Consumer Network
Susan Michie, University College London

Further Study Information

Current Stage: Planning
Date: July 2020 - September 2020
Funding source(s):


Health Area

Disease Category: Infectious disease, Public health

Disease Name: Coronavirus

Target Population

Age Range: Unknown

Sex:

Nature of Intervention:

Stakeholders Involved

Study Type

- COS for clinical trials or clinical research

Method(s)

Plans
(i) Establish core international stakeholder group and hold meetings to,
a. Agree the scope of the work (core COS and modules)
b. Establish long list based on expert opinion, selected reviews, review of registered trials (from https://covid-evidence.org/) and qualitative data (Bristol resource)
(ii) Establish subgroups (e.g. public health interventions, primary care, secondary care) for each module and hold meetings to look at long list and refine for wider consideration
(iii) Undertake Delphi surveys with multiple relevant stakeholder groups
(iv) Host online consensus meeting(s) to establish COS

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