Allison Tong discusses a global partnership involving patients, professionals, and the public to establish core outcomes for research in covid-19

“Most researchers are focussed on the viral load but what matters most to patients may not just be viral load.” Family member of a person with covid-19

In an urgent response to the covid-19 global pandemic, a staggering number of clinical trials are underway to evaluate treatments for people with suspected or confirmed covid-19. As of 30 March 2020, 781 trials were registered on the World Health Organisation’s (WHO) International Clinical Trials Registry Platform (ICTRP), and this number continues to rise sharply.

This has triggered efforts to quickly synthesise and translate the emerging evidence to support decision-making in practice and policy. A number of organisations, including Cochrane, have diverted their resources to producing high-priority rapid systematic reviews addressing covid-19. Just this week, the Australian Government announced that they had awarded the Australian Living Evidence Consortium, led by Cochrane Australia, A$1.5 million to establish the National covid-19 Clinical Evidence Taskforce. The taskforce will deliver “living guidelines” on the management of people with suspected or confirmed covid-19 across primary, acute, and critical care settings. With such limited time and finite resources, chair of the Taskforce, Julian Elliott, immediately recognised the need for “core outcomes” for covid-19. 

The Core Outcome Measures in Effective Trials (COMET) Initiative defines a core outcome set as a list of outcomes (the impacts of a specific disease or health condition or its treatment) that should be reported, as a minimum, in all clinical trials in a defined population. Core outcome sets help to ensure that resources are directed toward clinical and consumer priorities. 

As part of the Clinical Evidence Taskforce, the global covid-19 Core Outcome Set (COVID-19-COS) Project was launched in March 2020 to establish consensus on core outcomes to be reported in all trials in covid-19.

In an initial analysis of 280 trials, led by Tess Cooper from the covid-19-COS Project Team, more than 500 unique outcome measures were reported for 45 different outcomes. These included; mortality, acute respiratory distress syndrome, sepsis, financial impact, depression, lung function, muscle pain, pneumonia, physical function, viral load/clearance, multiple organ failure, and respiratory failure. The wide scope and heterogeneity in outcomes reported across trials in covid-19 can undermine the ability to assess the comparative effects of interventions across trials. This shows the immediate need for consensus on outcomes that are of critical importance to all stakeholders. 

With people in every corner of the world profoundly impacted by this crisis, everyone is a stakeholder—health professionals, people who have or are suspected to have covid-19, their families, and all members of the public. A post in the BMJ Opinion last month by Kaisa Immonen et al advocates for the inclusion of patients and the public in the policy response to covid-19. The same could be said for research. Patients and the public want access to valid and reliable information that addresses what matters to them, and thus should be involved as partners in developing core outcomes.

In such an unprecedented public health emergency, there are unique challenges in forming a patient-public-professional partnership in research—time, engagement, and empowerment. The process of establishing core outcomes usually takes at least 12 months, but now must be compressed to a few weeks and there is a danger that patient and public involvement is missed out in the process. People are focussed on saving lives and protecting the safety of themselves and the whole community and may not have to think about being involved in research. Someone on Twitter posted, “I’m seeing a lot of “of course [patient and public involvement] is necessary. We’re just so swamped with covid-19 work that no one has time to involve anyone.’” Some members of the public do not feel they have the expertise or knowledge to prioritise outcomes—“How would I know what should be a priority? Seems dangerous throwing it to non-medicos like me.” (feedback from a member of the general public on the covid-19-COS project).

Covid-19 should compel us to innovate and push the boundaries in patient and public involvement. In the COVID-19-COS project, we have developed strategies to ensure that involvement is flexible (e.g. convening a larger Steering Committee to “spread” the workload and allow contribution as is feasible for members, and to broaden access to networks to engage different stakeholders groups); to maximise confidence and buy in from the general community (e.g. making the concept of core outcomes accessible to the public); and harnessed the power of technology to enable participation (using video conferencing to convene multiple stakeholder workshops).

The voice of patients and the public must be heard. This is key to increasing the value of research in covid-19 to the entire community. As Tessa Richards summarises in her recent article, consistent reporting of outcomes that are critically important to all stakeholders reduces research waste, selective reporting of outcomes, and the “failure to include ones which matter and are relevant to patients.”

We are calling on the global community to give their opinion on what outcomes are most important for research in covid-19. The survey is available in English, Spanish, Italian and Chinese. For more information and to take part, please visit: www.covid-19-cos.org 

Allison Tong is a professor of Public Health at the Sydney School of Public Health, The University of Sydney and is principal investigator of the COVID-19-COS project (www.covid-19-cos.org) and the Standardised Outcomes in Nephrology (SONG) Initiative (www.songinitiative.org). She also established and chairs the Patient-centre Research (PACER) network (www.pacernetwork.org.au) 

Contributors: I would like to thank Jonathan Craig, Julian Elliot, Sally Crowe and the COVID-19-COS Steering Committee and Investigators for their feedback and contribution.

Competing interests: None declared

Twitter: @allisontong1