Quality of life and long-term outcomes after hospitalization for COVID-19: Protocol for a prospective cohort study (Coalition VII)

Rosa, Regis Goulart; Robinson, Caroline Cabral; Veiga, Viviane Cordeiro; Cavalcanti, Alexandre Biasi; de Azevedo, Luciano César Pontes; Machado, Flávia Ribeiro; Berwanger, Otavio; Avezum, Álvaro; Lopes, Renato Delascio; Lisboa, Thiago Costa; Teixeira, Cassiano; Zampieri, Fernando Godinho; Tomazini, Bruno Martins; Kawano-Dourado, Letícia; Schneider, Daniel; de Souza, Denise; dos Santos, Rosa da Rosa Minho; da Silva, Sabrina Souza; Trott, Geraldine; Gimenes, Bruna dos Passos; de Souza, Ana Paula; Barroso, Bruna Machado; Costa, Lauren Sezerá; Brognoli, Liége Gregoletto; Pelliccioli, Melissa Pezzetti; Studier, Nicole dos Santos; Schardosim, Raíne Fogliati de Carli; Haubert, Tainá Aparecida; Pallaoro, Victoria Emanuele Lobo; de Oliveira, Debora Mariani; Velho, Pedro Isaacsson; Medeiros, Gregory Saraiva; Gazzana, Marcelo Basso; Zavascki, Alexandre Prehn; Pitrez, Paulo Márcio; de Oliveira, Roselaine Pinheiro; Polanczyk, Carisi Anne; Nasi, Luiz Antônio; Hammes, Luciano Serpa; Falavigna, Maicon

INTRODUCTION: The long-term effects caused by COVID-19 are unknown. The present study aims to assess factors associated with health-related quality of life and long-term outcomes among survivors of hospitalization for COVID-19 in Brazil. METHODS: This is a multicenter prospective cohort study nested in five randomized clinical trials designed to assess the effects of specific COVID-19 treatments in over 50 centers in Brazil. Adult survivors of hospitalization due to proven or suspected SARS-CoV-2 infection will be followed-up for a period of 1 year by means of structured telephone interviews. The primary outcome is the 1-year utility score of health-related quality of life assessed by the EuroQol-5D3L. Secondary outcomes include all-cause mortality, major cardiovascular events, rehospitalizations, return to work or study, physical functional status assessed by the Lawton-Brody Instrumental Activities of Daily Living, dyspnea assessed by the modified Medical Research Council dyspnea scale, need for long-term ventilatory support, symptoms of anxiety and depression assessed by the Hospital Anxiety and Depression Scale, symptoms of posttraumatic stress disorder assessed by the Impact of Event Scale-Revised, and self-rated health assessed by the EuroQol-5D3L Visual Analog Scale. Generalized estimated equations will be performed to test the association between five sets of variables (1- demographic characteristics, 2- premorbid state of health, 3- characteristics of acute illness, 4- specific COVID-19 treatments received, and 5- time-updated postdischarge variables) and outcomes. ETHICS AND DISSEMINATION: The study protocol was approved by the Research Ethics Committee of all participant institutions. The results will be disseminated through conferences and peer-reviewed journals.