TY - JOUR
T1 - Study protocol for the Innovative Support for Patients with SARS-COV-2 Infections Registry (INSPIRE)
T2 - A longitudinal study of the medium and long-term sequelae of SARS-CoV-2 infection
AU - O'Laughlin, Kelli N.
AU - Thompson, Matthew
AU - Hota, Bala
AU - Gottlieb, Michael
AU - Plumb, Ian D.
AU - Chang, Anna Marie
AU - Wisk, Lauren E.
AU - Hall, Aron J.
AU - Wang, Ralph C.
AU - Spatz, Erica S.
AU - Stephens, Kari A.
AU - Huebinger, Ryan M.
AU - McDonald, Samuel A.
AU - Venkatesh, Arjun
AU - Gentile, Nikki
AU - Slovis, Benjamin H.
AU - Hill, Mandy
AU - Saydah, Sharon
AU - Idris, Ahamed H.
AU - Rodriguez, Robert
AU - Krumholz, Harlan M.
AU - Elmore, Joann G.
AU - Weinstein, Robert A.
AU - Nichol, Graham
N1 - Publisher Copyright:
© 2022 This is an open access article, free of all copyright, and may be freely reproduced, distributed, transmitted, modified, built upon, or otherwise used by anyone for any lawful purpose. The work is made available under the Creative Commons CC0 public domain dedication.
PY - 2022/3
Y1 - 2022/3
N2 - Background Reports on medium and long-term sequelae of SARS-CoV-2 infections largely lack quantification of incidence and relative risk. We describe the rationale and methods of the Innovative Support for Patients with SARS-CoV-2 Registry (INSPIRE) that combines patientreported outcomes with data from digital health records to understand predictors and impacts of SARS-CoV-2 infection. Methods INSPIRE is a prospective, multicenter, longitudinal study of individuals with symptoms of SARS-CoV-2 infection in eight regions across the US. Adults are eligible for enrollment if they are fluent in English or Spanish, reported symptoms suggestive of acute SARS-CoV-2 infection, and if they are within 42 days of having a SARS-CoV-2 viral test (i.e., nucleic acid amplification test or antigen test), regardless of test results. Recruitment occurs in-person, by phone or email, and through online advertisement. A secure online platform is used to facilitate the collation of consent-related materials, digital health records, and responses to self-administered surveys. Participants are followed for up to 18 months, with patientreported outcomes collected every three months via survey and linked to concurrent digital health data; follow-up includes no in-person involvement. Our planned enrollment is 4,800 participants, including 2,400 SARS-CoV-2 positive and 2,400 SARS-CoV-2 negative participants (as a concurrent comparison group). These data will allow assessment of longitudinal outcomes from SARS-CoV-2 infection and comparison of the relative risk of outcomes in individuals with and without infection. Patient-reported outcomes include self-reported health function and status, as well as clinical outcomes including health system encounters and new diagnoses. Results Participating sites obtained institutional review board approval. Enrollment and follow-up are ongoing. Conclusions This study will characterize medium and long-term sequelae of SARS-CoV-2 infection among a diverse population, predictors of sequelae, and their relative risk compared to persons with similar symptomatology but without SARS-CoV-2 infection. These data may inform clinical interventions for individuals with sequelae of SARS-CoV-2 infection.
AB - Background Reports on medium and long-term sequelae of SARS-CoV-2 infections largely lack quantification of incidence and relative risk. We describe the rationale and methods of the Innovative Support for Patients with SARS-CoV-2 Registry (INSPIRE) that combines patientreported outcomes with data from digital health records to understand predictors and impacts of SARS-CoV-2 infection. Methods INSPIRE is a prospective, multicenter, longitudinal study of individuals with symptoms of SARS-CoV-2 infection in eight regions across the US. Adults are eligible for enrollment if they are fluent in English or Spanish, reported symptoms suggestive of acute SARS-CoV-2 infection, and if they are within 42 days of having a SARS-CoV-2 viral test (i.e., nucleic acid amplification test or antigen test), regardless of test results. Recruitment occurs in-person, by phone or email, and through online advertisement. A secure online platform is used to facilitate the collation of consent-related materials, digital health records, and responses to self-administered surveys. Participants are followed for up to 18 months, with patientreported outcomes collected every three months via survey and linked to concurrent digital health data; follow-up includes no in-person involvement. Our planned enrollment is 4,800 participants, including 2,400 SARS-CoV-2 positive and 2,400 SARS-CoV-2 negative participants (as a concurrent comparison group). These data will allow assessment of longitudinal outcomes from SARS-CoV-2 infection and comparison of the relative risk of outcomes in individuals with and without infection. Patient-reported outcomes include self-reported health function and status, as well as clinical outcomes including health system encounters and new diagnoses. Results Participating sites obtained institutional review board approval. Enrollment and follow-up are ongoing. Conclusions This study will characterize medium and long-term sequelae of SARS-CoV-2 infection among a diverse population, predictors of sequelae, and their relative risk compared to persons with similar symptomatology but without SARS-CoV-2 infection. These data may inform clinical interventions for individuals with sequelae of SARS-CoV-2 infection.
UR - https://www.scopus.com/pages/publications/85125691122
UR - https://www.scopus.com/pages/publications/85125691122#tab=citedBy
U2 - 10.1371/journal.pone.0264260
DO - 10.1371/journal.pone.0264260
M3 - Article
C2 - 35239680
AN - SCOPUS:85125691122
SN - 1932-6203
VL - 17
JO - PloS one
JF - PloS one
IS - 3 March
M1 - e0264260
ER -