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Published on: November 10, 2023
International Survey to Establish Prioritized Outcomes for Trials in People With Coronavirus Disease 2019
Nicole Evangelidis1,2, Allison Tong1,2, Martin Howell1,2
1Sydney School of Public Health, The University of Sydney, Sydney, NSW, Australia.
Objectives:
There are over 4,000 trials conducted in people with coronavirus disease 2019. However, the variability of outcomes and the omission of patient-centered outcomes may diminish the impact of these trials on decision-making. The aim of this study was to generate a consensus-based, prioritized list of outcomes for coronavirus disease 2019 trials.
Design:
In an online survey conducted in English, Chinese, Italian, Portuguese, and Spanish languages, adults with coronavirus disease 2019, their family members, health professionals, and the general public rated the importance of outcomes using a 9-point Likert scale (7-9, critical importance) and completed a Best-Worst Scale to estimate relative importance. Participant comments were analyzed thematically.
Setting:
International.
Subjects:
Adults 18 years old and over with confirmed or suspected coronavirus disease 2019, their family members, members of the general public, and health professionals (including clinicians, policy makers, regulators, funders, and researchers).
Interventions:
None.
Measurements:
None.
Main Results:
In total, 9,289 participants from 111 countries (776 people with coronavirus disease 2019 or family members, 4,882 health professionals, and 3,631 members of the public) completed the survey. The four outcomes of highest priority for all three groups were: mortality, respiratory failure, pneumonia, and organ failure. Lung function, lung scarring, sepsis, shortness of breath, and oxygen level in the blood were common to the top 10 outcomes across all three groups (mean > 7.5, median ≥ 8, and > 70% of respondents rated the outcome as critically important). Patients/family members rated fatigue, anxiety, chest pain, muscle pain, gastrointestinal problems, and cardiovascular disease higher than health professionals. Four themes underpinned prioritization: fear of life-threatening, debilitating, and permanent consequences; addressing knowledge gaps; enabling preparedness and planning; and tolerable or infrequent outcomes.
Conclusions:
Life-threatening respiratory and other organ outcomes were consistently highly prioritized by all stakeholder groups. Patients/family members gave higher priority to many patient-reported outcomes compared with health professionals.
Insights
Prioritizing outcomes in coronavirus disease 2019 (COVID-19) trials is crucial. This study identified key outcomes like mortality and respiratory failure, emphasizing patient-centered results for better decision-making.
Area of Science:
- Clinical Research
- Public Health
- Epidemiology
Background:
- Over 4,000 clinical trials for coronavirus disease 2019 (COVID-19) exist.
- Variability in outcomes and lack of patient-centered data may limit trial impact.
- A consensus-based list of prioritized outcomes is needed for COVID-19 research.
Purpose of the Study:
- To generate a consensus-based, prioritized list of outcomes for COVID-19 trials.
- To ensure trial outcomes align with patient and stakeholder priorities.
- To improve the relevance and impact of COVID-19 research.
Main Methods:
- An international online survey was conducted in multiple languages.
- Participants included adults with COVID-19, family members, health professionals, and the public.
- Outcomes were rated using a 9-point Likert scale and a Best-Worst Scale; comments were thematically analyzed.
Main Results:
- 9,289 participants from 111 countries completed the survey.
- Mortality, respiratory failure, pneumonia, and organ failure were top priorities for all groups.
- Patients/family members prioritized symptoms like fatigue and anxiety higher than health professionals.
Conclusions:
- Life-threatening respiratory and organ outcomes are consistently prioritized across stakeholder groups.
- Patient-reported outcomes, such as fatigue and anxiety, received higher priority from patients/family members.
- Prioritization was driven by fear of severe consequences, knowledge gaps, and preparedness needs.
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