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

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

Abstract

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.

Conflict of interest statement

Conflicts of interest: None.

Figures

Figure 1
Figure 1
Schedule of enrollment, assessments and follow-up.

References

    1. Huang C, Wang Y, Li X, Ren L, Zhao J, Hu Y, et al. Clinical features of patients infected with 2019 novel coronavirus in Wuhan, China. Lancet. 2020;395(10223):497–506.
    1. Mahase E. Covid-19: most patients require mechanical ventilation in first 24 hours of critical care. BMJ. 2020;368:m1201–m1201.
    1. Yang X, Yu Y, Xu J, Shu H, Xia J, Liu H, et al. Clinical course and outcomes of critically ill patients with SARS-CoV-2 pneumonia in Wuhan, China: a single-centered, retrospective, observational study. Lancet Respir Med. 2020;8(5):475–481.
    1. Wang D, Hu B, Hu C, Zhu F, Liu X, Zhang J, et al. Clinical characteristics of 138 hospitalized patients with 2019 novel coronavirus-infected pneumonia in Wuhan, China. JAMA. 2020;323(11):1061–1069.
    1. Pun BT, Badenes R, Heras La Calle G, Orun OM, Chen W, Raman R, Simpson BK, Wilson-Linville S, Hinojal Olmedillo B, Vallejo de la Cueva A, van der Jagt M, Navarro Casado R, Leal Sanz P, Orhun G, Ferrer Gómez C, Núñez Vázquez K, Piñeiro Otero P, Taccone FS, Gallego Curto E, Caricato A, Woien H, Lacave G, O'Neal HR Jr, Peterson SJ, Brummel NE, Girard TD, Ely EW, Pandharipande PP, COVID-19 Intensive Care International Study Group Prevalence and risk factors for delirium in critically ill patients with COVID-19 (COVID-D): a multicentre cohort. study. Lancet Respir Med. 2021 Jan 08; S2213-2600(20)30552-X.
    1. Grasselli G, Zangrillo A, Zanella A, Antonelli M, Cabrini L, Castelli A, Cereda D, Coluccello A, Foti G, Fumagalli R, Iotti G, Latronico N, Lorini L, Merler S, Natalini G, Piatti A, Ranieri MV, Scandroglio AM, Storti E, Cecconi M, Pesenti A, COVID-19 Lombardy ICU Network Baseline characteristics and outcomes of 1591 patients infected with SARS-CoV-2 admitted to ICUs of the Lombardy Region, Italy. JAMA. 2020;323(16):1574–1581.
    1. Bein T, Bienvenu OJ, Hopkins RO. Focus on long-term cognitive, psychological and physical impairments after critical illness. Intensive Care Med. 2019;45(10):1466–1468.
    1. Herridge MS, Cheung AM, Tansey CM, Matte-Martyn A, Diaz-Granados N, Al-Saidi F, Cooper AB, Guest CB, Mazer CD, Mehta S, Stewart TE, Barr A, Cook D, Slutsky AS, Canadian Critical Care Trials Group One-year outcomes in survivors of the acute respiratory distress syndrome. N Engl J Med. 2003;348(8):683–693.
    1. Wright JC, Plenderleith L, Ridley SA. Long-term survival following intensive care: subgroup analysis and comparison with the general population. Anaesthesia. 2003;58(7):637–642.
    1. Cuthbertson BH, Roughton S, Jenkinson D, Maclennan G, Vale L. Quality of life in the five years after intensive care: a cohort study. Crit Care. 2010;14(1):R6–R6.
    1. Rosa RG, Falavigna M, Robinson CC, Sanchez EC, Kochhann R, Schneider D, Sganzerla D, Dietrich C, Barbosa MG, de Souza D, Rech GS, Dos Santos RDR, da Silva AP, Santos MM, Dal Lago P, Sharshar T, Bozza FA, Teixeira C, Quality of Life After ICU Study Group Investigators and the BRICNet Early and late mortality following discharge from the ICU: a multicenter prospective cohort study. Crit Care Med. 2020;48(1):64–72.
    1. Zhou F, Yu T, Du R, Fan G, Liu Y, Liu Z, et al. Clinical course and risk factors for mortality of adult inpatients with COVID-19 in Wuhan, China: a retrospective cohort study. Lancet. 2020;395(10229):1054–1062.
    1. Richardson S, Hirsch JS, Narasimhan M, Crawford JM, McGinn T, Davidson KW, et al. Presenting characteristics, comorbidities, and outcomes among 5700 patients hospitalized with COVID-19 in the New York City Area. JAMA. 2020;323(20):2052–2059.
    1. Cavalcanti AB, Zampieri FG, Rosa RG, Azevedo LCP, Veiga VC, Avezum A, Damiani LP, Marcadenti A, Kawano-Dourado L, Lisboa T, Junqueira DLM, de Barros E Silva PGM, Tramujas L, Abreu-Silva EO, Laranjeira LN, Soares AT, Echenique LS, Pereira AJ, Freitas FGR, Gebara OCE, Dantas VCS, Furtado RHM, Milan EP, Golin NA, Cardoso FF, Maia IS, Hoffmann Filho CR, Kormann APM, Amazonas RB, Bocchi de Oliveira MF, Serpa-Neto A, Falavigna M, Lopes RD, Machado FR, Berwanger O, Coalition Covid-19 Brazil I Investigators Hydroxychloroquine with or without azithromycin in mild-to-moderate Covid-19. N Engl J Med. 2020;383(21):2041–2052.
    1. Furtado RH, Berwanger O, Fonseca HA, Corrêa TD, Ferraz LR, Lapa MG, Zampieri FG, Veiga VC, Azevedo LC, Rosa RG, Lopes RD, Avezum A, Manoel AL, Piza FM, Martins PA, Lisboa TC, Pereira AJ, Olivato GB, Dantas VC, Milan EP, Gebara OC, Amazonas RB, Oliveira MB, Soares RV, Moia DD, Piano LP, Castilho K, Momesso RG, Schettino GP, Rizzo LV, Neto AS, Machado FR, Cavalcanti AB, COALITION COVID-19 Brazil II Investigators Azithromycin in addition to standard of care versus standard of care alone in the treatment of patients admitted to the hospital with severe COVID-19 in Brazil (COALITION II): a randomised clinical trial. Lancet. 2020;396(10256):959–967.
    1. Tomazini BM, Maia IS, Cavalcanti AB, Berwanger O, Rosa RG, Veiga VC, Avezum A, Lopes RD, Bueno FR, Silva MV, Baldassare FP, Costa EL, Moura RA, Honorato MO, Costa AN, Damiani LP, Lisboa T, Kawano-Dourado L, Zampieri FG, Olivato GB, Righy C, Amendola CP, Roepke RM, Freitas DH, Forte DN, Freitas FG, Fernandes CC, Melro LM, Junior GF, Morais DC, Zung S, Machado FR, Azevedo LC, COALITION COVID-19 Brazil III Investigators Effect of dexamethasone on days alive and ventilator-free in patients with moderate or severe acute respiratory distress syndrome and COVID-19: the CoDEX randomized clinical trial. JAMA. 2020;324(13):1307–1316.
    1. Tomazini BM, Maia IS, Bueno FR, Silva MV, Baldassare FP, Costa EL, Moura RA, Honorato MO, Costa AN, Cavalcanti AB, Rosa RG, Avezum A, Veiga VC, Lopes RD, Damiani LP, Machado FR, Berwanger O, Azevedo LC, COALITION COVID-19 Brazil III Investigators COVID-19-associated ARDS treated with DEXamethasone (CoDEX): study design and rationale for a randomized trial. Rev Bras Ter Intensiva. 2020;32(3):354–362.
    1. Farias DL, Prats J, Cavalcanti AB, Rosa RG, Machado FR, Berwanger O, et al. Rationale and design of the "Tocilizumab in patients with moderate to severe COVID-19: an open-label multicentre randomized controlled" trial (TOCIBRAS) Rev Bras Ter Intensiva. 2020;32(3):337–347.
    1. Brasil. Ministério da Saúde. Secretaria de Ciência, Tecnologia, Inovação e Insumos Estratégicos em Saúde. Departamento de Gestão e Incorporação de Tecnologias e Inovação em Saúde. Coordenação-Geral de Gestão de Tecnologias em Saúde. Coordenação de Gestão de Protocolos Clínicos e Diretrizes Terapêuticas . Diretrizes para diagnóstico e tratamento da COVID-19. Brasília, DF: Ministério da Saúde; 2020. [2020 Mai 22]. Disponível em: .
    1. Santos M, Cintra MA, Monteiro AL, Santos B, Gusmão-Filho F, Andrade MV, et al. Brazilian valuation of EQ-5D-3L health states: results from a saturation study. Med Decis Making. 2016;36(2):253–263.
    1. Coretti S, Ruggeri M, McNamee P. The minimum clinically important difference for EQ-5D index: a critical review. Expert Rev Pharmacoecon Outcomes Res. 2014;14(2):221–233.
    1. Santos RL, Virtuoso Jr JS. Reliability of the Brazilian version of the Scale of Instrumental Activities of Daily Living. Rev Bras Prom Saúde. 2008;21(4):290–296.
    1. Bestall JC, Paul EA, Garrod R, Garnham R, Jones PW, Wedzicha JA. Usefulness of the Medical Research Council (MRC) dyspnoea scale as a measure of disability in patients with chronic obstructive pulmonary disease. Thorax. 1999;54(7):581–586.
    1. Zigmond AS, Snaith RP. The hospital anxiety and depression scale. Acta Psychiatr Scand. 1983;67(6):361–370.
    1. Caiuby AV, Lacerda SS, Quintana MI, Torii TS, Andreoli SB. Cross-cultural adaptation of the Brazilian version of the Impact of Events Scale-Revised (IES-R) Cad Saúde Publica. 2012;28(3):597–603. Portuguese.
    1. Harris PA, Taylor R, Thielke R, Payne J, Gonzalez N, Conde JG. Research electronic data capture (REDCap)--a metadata-driven methodology and workflow process for providing translational research informatics support. J Biomed Inform. 2009;42(2):377–381.
    1. Restrepo MI, Faverio P, Anzueto A. Long-term prognosis in community-acquired pneumonia. Curr Opin Infect Dis. 2013;26(2):151–158.
    1. R Development Core Team . R: A language and environment for statistical computing. Vienna, Austria: R Foundation for Statistical Computing; 2016. [2020 May 22]. Available from:
    1. Brasil. Ministério da Saúde. Conselho Nacional de Saúde (Brasil) Resolução no 466, de 12 de dezembro de 2012. Brasília: DF; 2012. [2020 Mai 22]. Disponível em: .
    1. ICH Harmonised Guideline Integrated Addendum to ICH E6(R1): Guideline for Good Clinical Practice ICH E6(R2) ICH Consensus Guideline International Conference on Harmonisation of technical requirements for registration of pharmaceuticals for human use. Guideline for good clinical practice. E6(R1) 2016. [2021 Feb 5]. Available from: .
    1. Herridge MS, Moss M, Hough CL, Hopkins RO, Rice TW, Bienvenu OJ, et al. Recovery and outcomes after the acute respiratory distress syndrome (ARDS) in patients and their family caregivers. Intensive Care Med. 2016;42(5):725–738.
    1. Ruhl AP, Huang M, Colantuoni E, Karmarkar T, Dinglas VD, Hopkins RO, Needham DM, With the National Institutes of Health, National Heart, Lung, and Blood Institute Acute Respiratory Distress Syndrome Network Healthcare utilization and costs in ARDS survivors: a 1-year longitudinal national US multicenter study. Intensive Care Med. 2017;43(7):980–991.
    1. Oeyen SG, Vandijck DM, Benoit DD, Annemans L, Decruyenaere JM. Quality of life after intensive care: a systematic review of the literature. Crit Care Med. 2010;38(12):2386–2400.
    1. Rosa RG, Kochhann R, Berto P, Biason L, Maccari JG, De Leon P, et al. More than the tip of the iceberg: association between disabilities and inability to attend a clinic-based post-ICU follow-up and how it may impact on health inequalities. Intensive Care Med. 2018;44(8):1352–1354.

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