Institutional research databank of multidisciplinary follow-up assessments after discharge

Follow-up assessments have been conducted with over 800 patients 6 to 11 months after hospital admission. Both symptom questionnaires and objective assessments have been conducted, with results organized in a REDCap-based dataset fully integrated with data from the hospital admissions and the COVID-19 Biobank. All ethical and data security principles have been applied following current standards of data protection and confidentiality. Individually identifiable data is never released.

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In June 2020, part of the donation funds received by HCFMUSP in the #HCCOMVIDA campaign, through the ViralCure platform, were allocated to the emergency support group for infrastructure and logistics coordinated by the Research Laboratories Executive Board. At that time, discussion began about investing part of these resources for an institutional program aimed at conducting periodic waves of multidisciplinary reassessments of the cohort of patients with COVID-19 who survived hospitalization at HCFMUSP, involving as many disciplines of the HCFMUSP System as possible.


In July-August 2020, scientific meetings were held to plan the first wave of re-evaluation of the above cohort (6 months after hospitalization), with the participation of representatives of the Scientific Committee of the LIMs, the Research Committee of FMUSP, and the Scientific Committees of all HCFMUSP Institutes. Exhaustive strategies were defined to invite research groups to participate in the initiative, and an alignment was made between the Executive Board of LIMs and the Heart Institute team headed by Carlos Roberto Ribeiro de Carvalho so that the proposals for individual follow-up projects that had already been gathered by that institute could be integrated into the institutional initiative.


More than 20 research groups joined this institutional initiative, bringing human and operational resources to make the collection of multidisciplinary data from hundreds of patients feasible without the need for much more external financial resources besides those raised through the donations mentioned above. Given the large number of visits planned, two re-evaluation centers were prepared to receive the patients: the Clinical Research Center of the Heart Institute (for patients with more severe conditions who were admitted to ICUs); and a center set up by the Superintendence of HCFMUSP and by the Clinical Board of HCFMUSP in the former area of the Servidor's Medical and Social Service - SAMSS (for inpatients with less severe conditions).


The components of the multidisciplinary follow-up assessments program were documented through an interconnected set of research projects, all of which were previously approved by the Ethics Committee for the Analysis of Research Projects of HCFMUSP.


Between October 2020 and April 2021, over 800 adults were reassessed by different teams between 6 and 11 months after hospitalization using a structured multidisciplinary protocol published in an international journal. The data collected has been used in several publications, and is accessible for new studies led by our groups and their external partners. Using similar principles, multidisciplinary re-evaluations of children and adolescents have also been conducted at the Children's Institute.


In June 2022, the Steering Committee COVID-19 approved a proposal for the FMUSP Library to manage for the first time in the institution the definition of the metadata regarding the material already used for publications arising from this action front. This work covers the formatting, thematic indexing, and organization of the repository of the datasets resulting from the use of COVID-19 institutional databases in studies published by researchers from the HC-FMUSP Complex, using Dataverse type software.


After completing the first wave of reevaluations, the follow-up work of the cohort is currently moving forward under the overall coordination of Carlos Roberto Ribeiro de Carvalho and Michelle Louvaes Garcia of the Heart Institute, in constant communication with the COVID-19 Steering Committee, and the post-doctoral fellow Ana Paula Ritto, who works full-time in the strategic and executive management of the institutional initiatives described herein, in constant communication with the management team of INOVA-HC, which funds her fellowship and supervised by the COVID-19 Steering Committee. A thematic project proposal has been submitted to FAPESP and is awaiting judgment, and our work is included among the post-COVID follow-up cohorts supported by the Instituto Todos pela Saúde.

Ethical and legal disclaimer

All ethical and data security principles have been applied following current standards of data protection and confidentiality. No identification of patients' personal information is made available. No individually identifiable data is shared with the researchers (i.e., data is "anonymized"). Researchers sign a legal agreement not to make any attempt to identify participants. Research projects applying for access to the HCFMUSP institutional databases must be approved in advance by the Ethics Committee of the institution to which the researcher is affiliated.


The sharing of data and samples for additional research studies is conditional on the strict need for confidentiality of individual participants’ data and samples. Access to our institutional data and samples requires agreement from the researcher in assuming their ethical and legal responsibility. Individually identifiable data is never released.