Core Outcome Measures for Trials in People With Coronavirus Disease 2019: Respiratory Failure, Multiorgan Failure, Shortness of Breath, and Recovery.
Tong A., Baumgart A., Evangelidis N., Viecelli AK., Carter SA., Azevedo LC., Cooper T., Bersten A., Cervantes L., Chew DP., Crowe S., Douglas IS., Flemyng E., Elliott JH., Hannan E., Horby P., Howell M., Ju A., Lee J., Lorca E., Lynch D., Manera KE., Marshall JC., Gonzalez AM., McKenzie A., Mehta S., Mer M., Morris AC., Needham DM., Nseir S., Povoa P., Reid M., Sakr Y., Shen N., Smyth AR., Simpson AJ., Snelling T., Strippoli GFM., Teixeira-Pinto A., Torres A., Turner T., Webb S., Williamson PR., Woc-Colburn L., Zhang J., Craig JC., COVID-19-Core Outcomes Set Investigators None.
ObjectivesRespiratory failure, multiple organ failure, shortness of breath, recovery, and mortality have been identified as critically important core outcomes by more than 9300 patients, health professionals, and the public from 111 countries in the global coronavirus disease 2019 core outcome set initiative. The aim of this project was to establish the core outcome measures for these domains for trials in coronavirus disease 2019.DesignThree online consensus workshops were convened to establish outcome measures for the four core domains of respiratory failure, multiple organ failure, shortness of breath, and recovery.SettingInternational.PatientsAbout 130 participants (patients, public, and health professionals) from 17 countries attended the three workshops.InterventionsNone.Measurements and main resultsRespiratory failure, assessed by the need for respiratory support based on the World Health Organization Clinical Progression Scale, was considered pragmatic, objective, and with broad applicability to various clinical scenarios. The Sequential Organ Failure Assessment was recommended for multiple organ failure, because it was routinely used in trials and clinical care, well validated, and feasible. The Modified Medical Research Council measure for shortness of breath, with minor adaptations (recall period of 24 hr to capture daily fluctuations and inclusion of activities to ensure relevance and to capture the extreme severity of shortness of breath in people with coronavirus disease 2019), was regarded as fit for purpose for this indication. The recovery measure was developed de novo and defined as the absence of symptoms, resumption of usual daily activities, and return to the previous state of health prior to the illness, using a 5-point Likert scale, and was endorsed.ConclusionsThe coronavirus disease 2019 core outcome set recommended core outcome measures have content validity and are considered the most feasible and acceptable among existing measures. Implementation of the core outcome measures in trials in coronavirus disease 2019 will ensure consistency and relevance of the evidence to inform decision-making and care of patients with coronavirus disease 2019.