Study protocol for the Innovative Support for Patients with SARS-COV-2 Infections Registry (INSPIRE): A longitudinal study of the medium and long-term sequelae of SARS-CoV-2 infection.
<h4>Background</h4>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 patient-reported...
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Public Library of Science (PLoS)
2022-01-01
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| Online Access: | https://journals.plos.org/plosone/article/file?id=10.1371/journal.pone.0264260&type=printable |
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| author | Kelli N O'Laughlin Matthew Thompson Bala Hota Michael Gottlieb Ian D Plumb Anna Marie Chang Lauren E Wisk Aron J Hall Ralph C Wang Erica S Spatz Kari A Stephens Ryan M Huebinger Samuel A McDonald Arjun Venkatesh Nikki Gentile Benjamin H Slovis Mandy Hill Sharon Saydah Ahamed H Idris Robert Rodriguez Harlan M Krumholz Joann G Elmore Robert A Weinstein Graham Nichol INSPIRE Investigators |
| author_facet | Kelli N O'Laughlin Matthew Thompson Bala Hota Michael Gottlieb Ian D Plumb Anna Marie Chang Lauren E Wisk Aron J Hall Ralph C Wang Erica S Spatz Kari A Stephens Ryan M Huebinger Samuel A McDonald Arjun Venkatesh Nikki Gentile Benjamin H Slovis Mandy Hill Sharon Saydah Ahamed H Idris Robert Rodriguez Harlan M Krumholz Joann G Elmore Robert A Weinstein Graham Nichol INSPIRE Investigators |
| author_sort | Kelli N O'Laughlin |
| collection | DOAJ |
| description | <h4>Background</h4>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 patient-reported outcomes with data from digital health records to understand predictors and impacts of SARS-CoV-2 infection.<h4>Methods</h4>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 patient-reported 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.<h4>Results</h4>Participating sites obtained institutional review board approval. Enrollment and follow-up are ongoing.<h4>Conclusions</h4>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. |
| format | Article |
| id | doaj-art-b08a57d0010d4dc89b02a853f1d9aee8 |
| institution | DOAJ |
| issn | 1932-6203 |
| language | English |
| publishDate | 2022-01-01 |
| publisher | Public Library of Science (PLoS) |
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| spelling | doaj-art-b08a57d0010d4dc89b02a853f1d9aee82025-08-20T02:46:25ZengPublic Library of Science (PLoS)PLoS ONE1932-62032022-01-01173e026426010.1371/journal.pone.0264260Study protocol for the Innovative Support for Patients with SARS-COV-2 Infections Registry (INSPIRE): A longitudinal study of the medium and long-term sequelae of SARS-CoV-2 infection.Kelli N O'LaughlinMatthew ThompsonBala HotaMichael GottliebIan D PlumbAnna Marie ChangLauren E WiskAron J HallRalph C WangErica S SpatzKari A StephensRyan M HuebingerSamuel A McDonaldArjun VenkateshNikki GentileBenjamin H SlovisMandy HillSharon SaydahAhamed H IdrisRobert RodriguezHarlan M KrumholzJoann G ElmoreRobert A WeinsteinGraham NicholINSPIRE Investigators<h4>Background</h4>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 patient-reported outcomes with data from digital health records to understand predictors and impacts of SARS-CoV-2 infection.<h4>Methods</h4>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 patient-reported 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.<h4>Results</h4>Participating sites obtained institutional review board approval. Enrollment and follow-up are ongoing.<h4>Conclusions</h4>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.https://journals.plos.org/plosone/article/file?id=10.1371/journal.pone.0264260&type=printable |
| spellingShingle | Kelli N O'Laughlin Matthew Thompson Bala Hota Michael Gottlieb Ian D Plumb Anna Marie Chang Lauren E Wisk Aron J Hall Ralph C Wang Erica S Spatz Kari A Stephens Ryan M Huebinger Samuel A McDonald Arjun Venkatesh Nikki Gentile Benjamin H Slovis Mandy Hill Sharon Saydah Ahamed H Idris Robert Rodriguez Harlan M Krumholz Joann G Elmore Robert A Weinstein Graham Nichol INSPIRE Investigators Study protocol for the Innovative Support for Patients with SARS-COV-2 Infections Registry (INSPIRE): A longitudinal study of the medium and long-term sequelae of SARS-CoV-2 infection. PLoS ONE |
| title | Study protocol for the Innovative Support for Patients with SARS-COV-2 Infections Registry (INSPIRE): A longitudinal study of the medium and long-term sequelae of SARS-CoV-2 infection. |
| title_full | Study protocol for the Innovative Support for Patients with SARS-COV-2 Infections Registry (INSPIRE): A longitudinal study of the medium and long-term sequelae of SARS-CoV-2 infection. |
| title_fullStr | Study protocol for the Innovative Support for Patients with SARS-COV-2 Infections Registry (INSPIRE): A longitudinal study of the medium and long-term sequelae of SARS-CoV-2 infection. |
| title_full_unstemmed | Study protocol for the Innovative Support for Patients with SARS-COV-2 Infections Registry (INSPIRE): A longitudinal study of the medium and long-term sequelae of SARS-CoV-2 infection. |
| title_short | Study protocol for the Innovative Support for Patients with SARS-COV-2 Infections Registry (INSPIRE): A longitudinal study of the medium and long-term sequelae of SARS-CoV-2 infection. |
| title_sort | study protocol for the innovative support for patients with sars cov 2 infections registry inspire a longitudinal study of the medium and long term sequelae of sars cov 2 infection |
| url | https://journals.plos.org/plosone/article/file?id=10.1371/journal.pone.0264260&type=printable |
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