International Survey to Establish Prioritized Outcomes for Trials in People With Coronavirus Disease 2019

Abstract

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.

Core Outcome Measures for Trials in People With Coronavirus Disease 2019: Respiratory Failure, Multiorgan Failure, Shortness of Breath, and Recovery

“…Respiratory failure, multiple organ failure, shortness of breath, recovery, and mortality were identified as critically important core outcome domains by patients with COVID-19, their family members, the general public, and health professionals ( 17 , 22 ). Here, we have identified the core outcome measures for all core outcome domains, except mortality, as the core measures have already been defined in the WHO Clinical Progression Scale ( 20 ).…”

“…During each workshop, we presented the COVID-19-COS process and core outcome domains ( 17 , 22 ), definitions (for respiratory failure [26], multiple organ failure [27–29], shortness of breath [30, 31], and recovery [17, 22, 32]), an overview of the measurement properties and feasibility considerations (24, 33), and a summary of existing measures based on a review of existing core outcome measures (20, 21, 27, 28, 34–38), registered and published trials in COVID-19 (19), and reviews of trials and measures in respiratory disease and critical illness (39–44). Existing measures were assessed using the COMET initiative and COnsensus-based Standards for the selection of health Measurement INstruments (COSMIN) framework (24, 33) to identify a proposed core outcome measure for discussion.…”

“…The WHO Clinical Progression Scale includes mechanical ventilation and vasopressors, dialysis, or ECMO ( 22 ). Other common measures frequently used in trials in COVID-19 included the Sequential Organ Failure Assessment (SOFA) or quick SOFA (systolic blood pressure, respiratory rate, and Glasgow coma scale) and the Multiple Organ Dysfunction Score (MODS).…”

Challenges in defining Long COVID: Striking differences across literature, Electronic Health Records, and patient-reported information

“…185 Some work has been done to create various types of CDSs and COSs for clinical trials of acute COVID-19. 170,[186][187][188] While this work is important for the acute period of COVID-19, these efforts do not focus on the long-term outcomes associated with Long COVID. To date no work has been done to explore what is important to patients with Long COVID.…”

Predicting critical illness on initial diagnosis of COVID-19 based on easily-obtained clinical variables: Development and validation of the PRIORITY model

“…10,24 Moreover, this composite outcome captures the prioritized outcomes included in the COVID-19 core outcomes set. 25…”